Medical Device Newsletter

01-10-2024

EU drug regulator authorise use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents

Bavarian Nordic A/S, a vaccine company focused on protecting lives through innovative vaccines, has announced that the European Commission has approved the Committee fo

30-09-2024

Avicenna.AI gets 510(k) clearance for CINA-CSpine tool

The U.S. Food and Drug Administration (FDA) has approved Avicenna.AI’s CINA-CSpine tool under the 510(k) clearance. This AI-driven solution is designed to automat

30-09-2024

Tandem obtains approval for t:slim X2 insulin pump to use with Lyumjev

Tandem Diabetes Care has received European Union (EU) approval for its t:slim X2 insulin pump, featuring Control-IQ automated insulin delivery technology, to be used wi

30-09-2024

Smiths Medical recalls airway tubes because of defect linked to more than 10 injuries

Smiths Medical has recalled tracheostomy kits, including the Portex Bluselect, Blugriggs, and Bluperc kits, due to a manufacturing defect that may cause the balloon to

30-09-2024

Synchron integrates brain-computer interface tech to Amazon Alexa

A patient with amyotrophic lateral sclerosis has successfully used Synchron’s brain-computer interface (BCI) technology to control his smart home. Utilizing the B

27-09-2024

Lexogen launches LUTHOR HD Pool high-throughput single-cell RNA-Seq kit and LUTHOR single cell dispenser.

Lexogen, a leader in RNA sequencing technologies, has launched two innovative products to enhance single-cell RNA sequencing: the LUTHOR HD Pool high-throughput RNA-Seq

25-09-2024

Roche to launch new CGM in Europe

Roche is set to launch its Accu-Chek Smartguide in the Netherlands, Switzerland, and Germany, aiming to differentiate itself with hypoglycemia prediction features. The

25-09-2024

Medtronic collaborates with Siemens Healthineers for spine surgery tech

Siemens Healthineers will integrate its robotic X-ray imaging system with Medtronic’s spine surgery suite to enhance pre- and post-operative imaging technologies

24-09-2024

Smiths Medical associates 1 death, 35 injuries to defective airway tubes

Smiths Medical, now part of ICU Medical, has issued a recall for certain Bivona adult and pediatric tracheostomy tubes due to a manufacturing defect that could lead to

23-09-2024

Apple obtains FDA nod for hearing aid software for selected Airpods

The FDA has authorized a hearing aid feature for select Apple AirPods Pro models, making Apple the first company to gain approval for over-the-counter (OTC) hearing aid

20-09-2024

Roche bolsters AI-driven cancer diagnostics by advancing its digital pathology open environment

Roche has expanded its digital pathology open environment by integrating over 20 advanced AI algorithms from eight new partners. These collaborations aim to enhance can

19-09-2024

A new Device to tone facial muscles and reverse aging unveiled in India.

Dr. Rickson's Dermatherapie Clinic introduced a groundbreaking device in India to tone facial muscles and combat aging. The launch was attended by Julia Belianskaia, CE

16-09-2024

Abbott launches Lingo over-the-counter CGM in the US

Abbott has introduced Lingo, its first over-the-counter glucose sensor in the U.S., shortly after Dexcom launched its similar product. Lingo, priced at $49 for one 14-d

15-09-2024

Abbott collaborates with maker of ‘bionic pancreas’

In May 2022, Abbott received FDA clearance for its FreeStyle Libre 3 continuous glucose monitor (CGM), and introduced the FreeStyle Libre 3 Plus with longer wear time a

14-09-2024

FDA (Taiwan) authorise Moderna’s Covid-19 mRNA vaccine targeting the SARS-COV-2 variant JN.1

Moderna, Inc., a pioneer in mRNA medicine, announced that Taiwan's Food & Drug Administration (FDA) has approved a new version of the Spikevax Covid-19 mRNA vaccine

09-09-2024

CareFirst, Johns Hopkins, Techstars introduce healthcare AI accelerator

Johns Hopkins University and CareFirst BlueCross BlueShield have teamed up with Techstars to launch an accelerator focused on healthcare AI startups. The 13-week progra

09-09-2024

Embecta obtains FDA clearance for disposable insulin patch pump

Embecta (Nasdaq: EMBC), a spinoff from BD Diabetes, has received FDA 510(k) clearance for its new disposable insulin delivery system. Intended for adults with type 1 an

06-09-2024

AngioDynamics received CE mark for atherectomy system

AngioDynamics (Nasdaq: ANGO) won CE mark approval for its Auryon atherectomy system, designed to treat peripheral artery disease (PAD), including critical limb ischemia

06-09-2024

VFL Sciences declares foray into bioreactors and fermenters

VFL Sciences Private Limited has launched the GreatFlo series of benchtop fermenters/bioreactors, including the GreatFlo Expert and Proficient models. These versatile s

06-09-2024

CurifyLabs and APL collaborate to support critically ill patients with 3D printing medicine technology

Apotek Produktion & Laboratorier (APL), a major producer of extemporaneous medicines and a top CDMO in Sweden, has partnered with Finnish health tech company Curify

05-09-2024

Boston Scientific gets CE mark for upgraded TAVR technology

Boston Scientific has received a CE mark for Acurate Prime, its latest transcatheter aortic valve replacement (TAVR) device. This new system is an upgrade from the Neo2

02-09-2024

Emergency Use Authorization to Novavax 2024-2025 Formula Covid-19 vaccine to prevent Covid-19 in individuals aged 12 and older: US FDA

Novavax, Inc. announced that its Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the US Food

31-08-2024

Qiagen expands collaboration with AstraZeneca to develop and commercialize companion diagnostics, QIAstat-Dx

Qiagen has expanded its Master Collaboration Agreement with AstraZeneca to develop companion diagnostics (CDx) for AstraZeneca’s chronic disease therapies. Qiagen

31-08-2024

European Commission authorises expanded age indication for GSK’s Arexvy: The first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk

GSK plc announced that the European Commission has approved Arexvy (a recombinant adjuvanted RSV vaccine) for preventing lower respiratory tract disease (LRTD) caused b

30-08-2024

IASST scientists design new smart sensor for adjustment of drug dosage to manage Parkinson’s disease

Scientists at the Institute of Advanced Study in Science and Technology (IASST) have developed a portable, smartphone-based fluorescence sensor to manage Parkinson's di

30-08-2024

Qure.ai introduces FDA-cleared AI solution for advanced lung nodule quantification on CT scans at AABIP (American Association for Bronchology and Interventional Pulmonology) 2024

Qure.ai, a leader in medical imaging AI, has secured a significant 510(k) FDA clearance for its AI-powered chest CT solution, qCT LN Quant. This tool is designed to ass

28-08-2024

Accuray Helix receives CE Mark-Accuray’s new helical radiation delivery system

Accuray Incorporated announced the CE Mark approval for Accuray Helix, a CT-guided helical radiotherapy system designed for high performance and efficiency. Targeting e

28-08-2024

US FDA approves the next-generation, AI-powered platform for Aquablation therapy-PROCEPT BioRobotics’ HYDROS Robotic System

PROCEPT BioRobotics Corporation has received FDA 510(k) clearance for its next-generation HYDROS Robotic System. This advanced platform, designed for Aquablation therap

28-08-2024

US FDA clears Insulet SmartAdjust technology, a device to power automated insulin dosing for individuals with type 2 diabetes

The FDA has expanded the use of Insulet SmartAdjust technology to manage type 2 diabetes in individuals 18 and older. Previously approved only for type 1 diabetes, Smar

26-08-2024

NOWDiagnostics First To Know Syphilis Test gets US FDA De Novo marketing authorization for OTC use

NOWDiagnostics, Inc. (NOWDx) has received FDA authorization for its First To Know Syphilis Test, the first OTC rapid syphilis test in the US. This test provides results

23-08-2024

Roche responds to WHO’s declaration of a global health emergency because of the ongoing mpox outbreak

Roche is supporting the global response to mpox, formerly monkeypox, with its diagnostic tests. Declared a Public Health Emergency of International Concern by the WHO o

22-08-2024

HistoSonics’ technology to treat liver tumours : Renown Health

Renown Health recently reported the successful use of HistoSonics' Edison System histotripsy technology in treating liver tumors. This system is designed for non-invasi

21-08-2024

Materna’s device successfully prevents first-time mothers from pelvic floor injury.

Materna Medical has showcased positive results from its pelvic floor dilator designed to reduce muscle injury during first-time vaginal deliveries. Published in the *In

19-08-2024

Beurer blood pressure monitors earns US validation

Beurer announced receiving validation for four of its blood pressure monitors and being listed as US Blood Pressure Devices, meeting the Validated Device Listing (VDL)

18-08-2024

Fractyl Health reported favourable year-long weight loss outcomes for Revita device

Fractyl Health has announced promising outcomes for its hydrothermal ablation device, Revita, positioning it as a competitor to the growing pharmaceutical weight loss m

18-08-2024

Huxley Medical acquires FDA clearance for its sleep apnoea diagnostic patch

Huxley Medical has received FDA 510(k) clearance for its SANSA sleep apnea diagnostic patch. This innovative, chest-worn device simplifies the diagnosis of sleep apnea,

17-08-2024

Abbott collaborates with Medtronic for diabetes technology

In April 2023, Medtronic received FDA approval for its MiniMed 780G insulin pump. Medtronic has announced a partnership with Abbott to develop an integrated continuous

17-08-2024

Injuries trigger Medtronic to recall its nerve monitoring system.

Medtronic initiated recalling a nerve monitoring system linked to 10 reported injuries. Although the devices remain on the market, Medtronic has cautioned that the syst

16-08-2024

Smiths Medical recalls infusion pumps due to software issues

Smiths Medical has recalled CADD-Solis ambulatory infusion pumps due to issues linked to outdated software, according to the FDA. Problems include failures to emit alar

15-08-2024

J&J introduces Velys Spine surgical robotics and navigation platform

Johnson & Johnson has launched the Velys Spine, a surgical robot and navigation platform developed with eCential Robotics. The 510(k)-cleared system assists in scre

12-08-2024

MiRus gets US FDA Breakthrough Device Designation for EUROPA PCF system- spine implant

MiRus, a life sciences company, has received FDA Breakthrough Device Designation for its EUROPA Posterior Cervical System, which uses proprietary rhenium alloys for cer

12-08-2024

Inspire obtains FDA approval for obstructive sleep apnea neurostimulator therapy

Inspire Medical Systems has received FDA approval for its Inspire V neurostimulator therapy for obstructive sleep apnea (OSA). A soft launch is planned for late 2024, w

12-08-2024

Terumo India introduces TREO abdominal stent-graft system

Terumo India, a subsidiary of Terumo Corporation, has launched the TREO Stent-Graft System, an advanced solution for endovascular aneurysm repair (EVAR). This system, d

07-08-2024

Retrieve Medical partners with OnPoint Healthcare to integrate AI-powered Retrieve Medical engine into OnPoint’s proprietary IRIS platform technology

Retrieve Medical, Inc., a leader in healthcare technology, has announced a partnership with OnPoint Healthcare Partners, Inc. to integrate its AI-powered engine into On

05-08-2024

Haemonetics obtains CE Mark certification for SavvyWire pre-shaped pressure guidewire

Haemonetics Corporation, a global medical technology leader, has received CE Mark certification for its SavvyWire pre-shaped pressure guidewire, marking the first comme

05-08-2024

MiMedx launches Heliogen Fibrillar Collagen Matrix for management of moderately to heavily exudating wounds

MiMedx Group, Inc. has launched Heliogen Fibrillar Collagen Matrix, a new particulate xenograft designed to treat complex wounds, especially in surgical settings. This

05-08-2024

DePuy Synthes launches active spine robotics and navigation platform, VELYS Active Robotic-Assisted System

Johnson & Johnson MedTech has announced that DePuy Synthes is launching the VELYS Active Robotic-Assisted System (VELYS SPINE), developed in partnership with eCenti

03-08-2024

Microarray immunoassay in allergy diagnostics obtains IVDR CE marking: AliveDx

AliveDx, a global in vitro diagnostics company, has received IVDR CE mark certification for its groundbreaking microarray immunoassay, designed to detect specific IgE a

02-08-2024

MiRus obtains US FDA Breakthrough Device Designation for spine implant, EUROPA PCF system

MiRus, a life sciences company based in Atlanta, Georgia, has received Breakthrough Device Designation from the FDA for its EUROPA Posterior Cervical System, which util

02-08-2024

Immunovia completes development of its pancreatic cancer detection test

Immunovia, a pancreatic cancer diagnostics company, has announced enhanced performance for its next-generation test, designed to detect stage 1 and 2 pancreatic ductal

02-08-2024

Mahajan Imaging & Labs launches AI integrated advanced cardiac screening and head to toe imaging low dose dual energy Spectral CT scanner

Mahajan Imaging & Labs has introduced a state-of-the-art Dual Energy Spectral CT scanner at its Gurugram center, offering advanced diagnostic capabilities. This sca

01-08-2024

ViaLase obtains CE Mark for its ViaLase Laser, a femtosecond laser for treatment of glaucoma

ViaLase, Inc., a clinical-stage medical technology company, has received CE Mark approval in the European Union for its ViaLase Laser, designed to treat adult patients

31-07-2024

UK MHRA approves Pfizer/BioNTech’s Comirnaty JN.1 Covid-19 vaccine for children from infancy and adults

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new version of the Pfizer/BioNTech Covid-19 vaccine, Comirnaty, targeting the JN.1 Covi

30-07-2024

OneSource & Bhami’s Research Lab signs licensing agreement for technology to deliver high-concentration biologics subcutaneously

OneSource Specialty Pharma, an associate company of Strides and India’s first specialty pharma pure-play CDMO (contract development and manufacturing organization

29-07-2024

Restore Medical’s ContraBand device gets FDA’s breakthrough status

Restore Medical has received breakthrough device designation from the FDA for its ContraBand system to treat left ventricle (LV) failure. This system is the first trans

27-07-2024

US FDA approves Positrigo’s brain PET system, NeuroLF

Positrigo, a Swiss company developing nuclear medical imaging devices, has achieved a milestone with FDA clearance for its NeuroLF brain PET system. This ultra-compact

27-07-2024

Inspire Medical Systems obtains CE mark certification of full-body MRI compatibility under the European Union’s Medical Device Regulation

Inspire Medical Systems, Inc. (Inspire) has announced that the European Union Medical Device Regulation (EU MDR) now approves full-body MRI scans for patients using its

27-07-2024

HeartFlow exhibits plaque analysis platform ‘HeartFlow Plaque Analysis’ to analyse patient risk in suspected coronary artery disease

HeartFlow, a leader in non-invasive AI heart care, has launched an advanced version of HeartFlow Plaque Analysis featuring an interactive experience. This updated tool

27-07-2024

OHSU-led research highlights promise for a universal flu vaccine

New research from Oregon Health & Science University (OHSU) explores a potential universal influenza vaccine that could offer lifetime protection against evolving f

26-07-2024

BD, Quest Diagnostics colloborate forces to develop companion diagnostics for cancer, other diseases

BD (Becton, Dickinson and Company) and Quest Diagnostics have announced a global partnership to advance flow cytometry-based companion diagnostics (CDx) for cancer and

25-07-2024

Hamilton recalls ventilators due to failure to restart

Hamilton Medical has recalled ventilators due to a potential failure to restart, as reported by the FDA. This issue can cause low blood oxygen, slow heart rate, and oth

24-07-2024

HeartFlow introduces plaque analysis platform for coronary artery disease

HeartFlow has launched the next-generation HeartFlow Plaque Analysis platform to improve clinical decision-making for suspected coronary artery disease (CAD). This adva

23-07-2024

Philips recall of imaging coils associated with 12 injuries

Philips has recalled several models of its Sense XL Torso coils due to the risk of overheating during MRI scans, which can cause burns to patients. The FDA's recall not

22-07-2024

World Health Organization prequalifies hepatitis C virus's OraQuick HCV self-test

The World Health Organization (WHO) has prequalified the first hepatitis C virus (HCV) self-test, enhancing testing access and global hepatitis C elimination efforts. T

21-07-2024

Roche wins CE mark for its first CGM

Roche has received a CE mark for its Accu-Chek Smartguide continuous glucose monitor (CGM), enabling it to compete with Abbott and Dexcom in the European market. Roche

19-07-2024

Philips recall of imaging coils linked to 12 injuries

Philips has recalled several Sense XL Torso coil models due to overheating risks during MRI scans, which can cause patient burns. An FDA recall notice issued Monday upd

15-07-2024

Medprime Technologies introduces Micalys, an innovative AI-integrated digital microscopy platform

Medprime Technologies has launched Micalys, an AI-integrated digital microscopy platform set to revolutionize digital pathology in India. Founded in 2014 by IIT Bombay

15-07-2024

Medtronic recalls endotracheal tubes due to blockage risk

The FDA has advised healthcare providers to stop using Medtronic's Nerve Integrity Monitoring (NIM) Standard and Contact EMG endotracheal tubes due to blockage risks. M

14-07-2024

Fischer Medical Ventures and Nervotec collaborate globally to enable haemoglobin, blood pressure, and HbA1C screening through camera- enabled device

Fischer Medical Ventures Limited, via its subsidiary Time Medical International Ventures (India) Private Limited, has partnered with Singapore-based Nervotec Pte Ltd to

13-07-2024

Trivitron Healthcare introduces Terrene CT scanner; becomes first Indian company to get BIS, AERB & CDSCO approvals for CT scanner manufacturing

Trivitron Healthcare, a leading global medical technology company, has launched the "Terrene" CT scanner, the first in India to receive certifications from BIS, AERB, a

13-07-2024

Zepp Health launches Zepp OS 4: redefining wearable intelligence by integration of OpenAI's GPT-4o into its Amazfit smartwatches

Zepp Health Corporation (Zepp Health) has launched Zepp OS 4, an advanced wearable technology integrating OpenAI’s GPT-4o system to enhance Amazfit smartwatches.

12-07-2024

J&J limits use of Megadyne electrodes over burn risk

Johnson & Johnson (J&J) has restricted the use of three Megadyne patient return electrodes due to burn risks, specifying they should only be used for individual

08-07-2024

Signum Surgical’s BioHealx technology obtains FDA clearance

Signum Surgical has received De Novo clearance from the US Food and Drug Administration (FDA) for its BioHealx technology, designed to treat anal fistulas. BioHealx is

06-07-2024

Avicenna.AI obtains EU-MDR certification for five AI tools

Avicenna.AI, a medical imaging firm, has obtained Medical Device Regulation (MDR) certification for five AI algorithms used to screen severe conditions, certified as Cl

06-07-2024

Carestream introduces new imaging software and system upgrades

Carestream Health has upgraded its ImageView Software and DRX-Evolution Plus System to enhance technologist efficiency and patient workflow.

05-07-2024

HKUST researchers develop AI-based microscopic imaging system

A research team from the Hong Kong University of Science and Technology (HKUST) has developed an AI-powered microscopic imaging system called Computational High-through

05-07-2024

Insign Medical collaborates with AAEON to develop AI colonoscopy solution

Insign Medical Technology has partnered with AAEON to create "EndoDASS," an AI-enhanced endoscopic technology designed to improve the precision and safety of colonoscop

05-07-2024

India’s Dhiti Omics establishes SOPHiA DDM platform for solid tumour testing

India-based Dhiti Omics Technologies, a precision molecular diagnostics provider, has implemented the SOPHiA DDM Platform from Sophia Genetics, a cloud-native software

02-07-2024

Philips BiPAP recall now associated with 65 deaths, 952 injuries

Philips has reported 10 severe injuries and seven deaths linked to its A30 and A40 devices from 2011 to 2023, with no serious harm reported for V30 devices. The recall

02-07-2024

Abbott and Dexcom are introducing the first over-the-counter CGMs.

Dexcom is set to launch its first over-the-counter continuous glucose monitor, Stelo, in late August. This summer will see the release of the first OTC glucose sensors

02-07-2024

Edinburgh University student introduces new 15-minute HPV diagnostic device

Developed by a single postgraduate student at the University of Edinburgh, the non-invasive at-home test detects human papillomavirus (HPV) strains in menstrual blood w

30-06-2024

Embecta showcases its insulin patch pump at ADA

Embecta has submitted an open-loop version of its first patch pump to the FDA and is developing a closed-loop version. At the American Diabetes Association Scientific S

30-06-2024

Senseonics states 365-day CGM to double 2025 sales

Senseonics aims to double its user base and sales in 2025 with the launch of its 365-day continuous glucose monitor (CGM) implant. Currently a minor player with project

30-06-2024

Magnolia Medical introduces new technology-enabled service for sepsis

Magnolia Medical has launched Magnolia Analytics, a technology-driven service aimed at enhancing data capture and evaluating the clinical and cost-effectiveness of inte

25-06-2024

Meril introduces MISSO – knee replacement robot

Meril, an India-based medical device company, has launched MISSO, an advanced surgical robotic system for knee replacement procedures. MISSO, entirely made in India, of

25-06-2024

Merit Medical recalls plastic syringes manufactured by Jiangsu Shenli

Merit Medical Systems has recalled products containing plastic syringes from Chinese manufacturer Jiangsu Shenli Medical Production, per the FDA. The recall affects kit

24-06-2024

Teleflex catheter kit recall associated with 31 injuries, 3 deaths

Teleflex has recalled nearly 17,000 intra-aortic balloon catheter kits distributed in the U.S. between May 2022 and April 2024 due to concerns over a manufacturing erro

24-06-2024

Cardinal Health recalls procedure kits over plastic syringes made in China

Cardinal Health has recalled procedure kits containing plastic syringes from China's Jiangsu Shenli Medical Production, according to the Food and Drug Administration (F

24-06-2024

Globus Medical obtains FDA nod for ortho robot

Globus Medical has received FDA 510(k) clearance for its ExcelsiusFlex orthopedic robot ahead of schedule, according to an agency posting. The clearance was anticipated

24-06-2024

FDA creates transparency principles for AI in medical devices

The Food and Drug Administration (FDA), alongside Canada and the U.K., has established guiding principles for transparency in machine learning-enabled medical devices.

09-06-2024

Fischer Medical launches in global healthcare with affordable MRI system made in India

Fischer Medical Ventures, based in Chennai, has pioneered the cost-effective, high-quality production of Magnetic Resonance Imaging (MRI) systems, making it the first c

07-06-2024

Inspira Technologies’ cardiopulmonary bypass system, Inspira ART100 gets US FDA 510(k) clearance

Inspira Technologies OXY B.H.N. Ltd., a pioneering company in medical technology, has announced that it has received 510(k) class II clearance from the US Food and Drug

07-06-2024

Abbott obtains CE mark for dual-chamber leadless pacemaker

Abbott has received a CE mark for its dual-chamber leadless pacemaker, enabling sales in Europe. The Aveir DR system, with synchronized pacemakers for the right atrium

07-06-2024

Moon Surgical obtains FDA nod for commercial soft tissue robot

Moon Surgical has gained FDA clearance to market its Maestro soft tissue surgical robot commercially in the U.S., challenging Intuitive Surgical’s da Vinci system

07-06-2024

Dexcom pairs G7 CGM directly to Apple Watch in US

Apple Watch and Dexcom's G7 now offer real-time glucose readings on users' wrists, independently of their iPhones.

Dexcom's G7 CGM

06-06-2024

Medtronic recalls neurosurgery navigation system due to software error

Medtronic recalled its surgical navigation system for neurosurgery due to a software error causing incorrect biopsy tip stop measurements. The FDA reported 28 complaint

04-06-2024

Philips reports 7 deaths linked with BiPAP alarm problem

Philips Respironics has recalled certain BiPAP ventilators due to false alarm issues potentially causing shutdowns. Affected models include BiPAP A30, A40, and V30, alo

03-06-2024

Avita obtains FDA approval for cell harvesting device Recell GO System

Avita Medical has received FDA approval for its next-generation autologous cell harvesting device, the Recell GO System, designed for burns and skin defects. This syste

03-06-2024

Hologic recalls more than 53,000 radiographic markers associated with 71 injuries

Hologic has recalled over 53,000 radiographic markers linked to 71 reported injuries, as per the FDA. While the devices remain available, Hologic urges reporting any ad

03-06-2024

MarinHealth Medical Center introduces cardiac MRI tool

MarinHealth Medical Center has expanded its cardiac care services by launching cardiac magnetic resonance imaging (MRI) technology through the Haynes Cardiovascular Ins

03-06-2024

FDA declares OptumHealth’s infusion system recall as Class I

The FDA has issued a Class I recall for OptumHealth's infusion systems, the most severe classification, affecting 208 devices distributed in the US between August 2020

02-06-2024

FDA approves InnoVoyce’s VYLO Laser System for medical use

InnoVoyce's VYLO Laser System has obtained 510(k) clearance from the US Food and Drug Administration (FDA). The VYLO Laser System, using a 455nm blue light laser, deliv

29-05-2024

Route 92 catheter recall associated with 2 injuries, 1 death

Route 92 Medical has recalled about 1,000 catheters in the U.S. due to malfunctions linked to two patient injuries and one death, as per the FDA. Physicians use these c

28-05-2024

FDA declares Vyaire’s twin tube recall as Class I

Vyaire Medical faces another FDA setback, this time regarding tubes in its cardiopulmonary exercise test (CPET) system, following a prior Class I recall this year. The

27-05-2024

Teltonika’s TeltoHeart smart wristband gets CE MDR certification

Teltonika, a Lithuanian company, has obtained European CE MDR (Class IIa) certification for its TeltoHeart smart wristband, meeting medical device standards. This wrist

27-05-2024

FX Shoulder gets FDA 510(k) clearance for glenoid baseplates

FX Shoulder Solutions has received FDA 510(k) clearance for its full-wedge augmented glenoid baseplates, adding six new options to its portfolio. This expands the total

27-05-2024

BD obtains FDA approval for cervical cancer screening self-collection kit

BD has received FDA approval for a kit enabling self-collection of specimens for human papillomavirus (HPV) testing, allowing individuals to collect vaginal specimens i

20-05-2024

J&J’s Megadyne discontinues pediatric electrode pad after burn reports

Johnson & Johnson's Megadyne business has ceased production of a pediatric electrode pad due to reports of patient burns during procedures. Initially part of a Dece

19-05-2024

Boston Scientific : Recalls more than 1M angiographic catheters

Boston Scientific has globally recalled over 1 million angiographic catheters due to increased complaints about difficulties advancing the guidewire through the device&

17-05-2024

ClearPoint Neuro gets US FDA 510(k) clearance for its Prism Bone Anchor Accessory

ClearPoint Neuro, Inc., a global leader in device and therapy enablement for brain and spine, has received 510(k) clearance for its Prism Bone Anchor Accessory, marking

16-05-2024

Stereotaxis signs APT buyout to gain catheters for surgical robots

Stereotaxis, a surgical robot developer, is acquiring Access Point Technologies (APT) to bolster its capabilities in creating robotically steered diagnostic catheters f

16-05-2024

Abbott recalls Heartmate pump following 70 injuries, 2 deaths reported

Abbott recalled the Heartmate 3 left ventricular assist system due to blood leakage or air entering device seals. The FDA noted 81 incidents, including 70 injuries and

11-05-2024

US Medical Innovations’ ablation system gets FDA issues 510(k) clearance

The US Food and Drug Administration (FDA) has granted 510k clearance to US Medical Innovations for its Canady Helios Cold Plasma (CHCP) Ablation System, a novel technol

11-05-2024

Outset Medical receives FDA nod for dialysis accessory months after halting sales

Outset Medical has obtained 510(k) clearance for TabloCart with prefiltration, an accessory designed to eliminate sediment and minerals from water prior to entering the

11-05-2024

Masimo’s at-home baby monitor approved for use without prescription

Masimo has obtained FDA approval for its Stork baby monitor, enabling over-the-counter purchase without a prescription. This at-home system, utilizing pulse oximetry te

11-05-2024

Medtronic gets approval to sell renal denervation device in China

Medtronic has secured the first approval for a renal denervation system from China’s National Medical Products Administration (NMPA). This approval allows Medtron

10-05-2024

FDA approves CereVasc’s eShunt system study for hydrocephalus

The US Food and Drug Administration (FDA) has authorized investigational device exemption (IDE) for CereVasc to commence the STRIDE pivotal study, evaluating its eShunt

08-05-2024

United Imaging gets FDA clearance for uMR Jupiter 5T MRI system

United Imaging, a manufacturer of medical imaging and radiotherapy equipment, has obtained clearance from the US Food and Drug Administration (FDA) for its uMR Jupiter

07-05-2024

Optomed introduces AI fundus camera for instant diabetic retinopathy detection

Optomed USA launches Optomed Aurora AEYE, a handheld AI fundus camera for diabetic retinopathy's rapid detection beyond mild stages. Developed with AEYE Health, it faci

07-05-2024

GE HealthCare introduces radiation therapy computed tomography solution

GE HealthCare has unveiled Revolution RT, a radiation therapy computed tomography (CT) solution aimed at enhancing imaging precision while simplifying the simulation wo

06-05-2024

Senseonics obtains FDA clearance to pair CGM implant with insulin pumps

Senseonics announced it obtained an integrated continuous glucose monitoring (iCGM) designation from the FDA via the de novo pathway, enabling integration of its implan

06-05-2024

BrioHealth obtains FDA nod to trial BrioVAD ventricular assist device

BrioHealth Solutions has received FDA approval for its BrioVAD system under an investigational device exemption (IDE). The company aims to assess the BrioVAD's efficacy

30-04-2024

NeuroSmart Portable MER system paves way for improved treatments in Parkinson’s disease

The integration of brain pacemakers and the NeuroSmart Portable MER system marks a significant leap in Parkinson’s disease treatment, offering precise deep brain

30-04-2024

Infutronix infusion pump recall associated with 6 injuries, 1 death

Healthcare professionals rely on Infutronix's Nimbus infusion pump systems, also marketed as Halo, for administering medications and fluids. These devices deliver liqui

30-04-2024

Exo received FDA-clearance for AI tools and adds to handheld ultrasound system

Exo received FDA clearance for its Iris device in 2021 and expanded its capabilities in 2022. These clearances apply to handheld portable diagnostic ultrasound systems,

30-04-2024

Abbott received FDA approval for Esprit resorbable scaffold

Abbott's Esprit resorbable scaffold system gained FDA approval for treating blocked arteries below the knee (BTK). While angioplasty is favored over vein bypass surgery

29-04-2024

Fresenius Medical Care recalls 2M dialysis devices due to toxin exposure risk

In 2022, the FDA alerted healthcare providers to potential toxin exposure from Fresenius Medical Care hemodialysis systems, involving non-dioxin-like (NDL) polychlorina

29-04-2024

Medtronic received FDA approval for Inceptiv closed-loop spinal cord stimulator

Medtronic's Inceptiv closed-loop spinal cord stimulator (SCS) received FDA approval for chronic pain treatment, aiming to minimize overstimulation compared to open-loop

28-04-2024

FDA approves Lumicell’s breast cancer imaging tool

Lumisystem comprises two integral components: Lumisight and Lumicell DVS. Lumisight is a molecular entity sensitive to enzymes predominantly present in and around 

27-04-2024

Exactech recalls shoulder devices

In 2021, Exactech initiated a recall due to premature wear in hip replacement products, later identifying defective packaging lacking an essential oxygen barrier layer.

20-04-2024

Scopio Labs obtains de novo nod for bone marrow analysis software

Founded in 2015, Scopio aimed to revolutionize microscopy and has since achieved significant milestones. These include obtaining CE marks and FDA clearances, raising $6

19-04-2024

AtriCure launches cryoSPHERE+ probe for pain management

AtriCure has introduced the cryoSPHERE+ cryoablation probe to enhance post-operative pain management. This device, part of the cryoICE platform, received 510(K) clearan

19-04-2024

Lumicell secures FDA approval for imaging platform

Lumicell has obtained FDA approval for its LUMISIGHT optical imaging agent (NDA) and Lumicell Direct Visualization System (DVS) (PMA). Together known as LumiSystem, the

19-04-2024

GE HealthCare launches AI-enhanced ultrasound systems

GE Healthcare introduces Voluson Signature 20 and 18 ultrasound systems, integrating AI for women's health imaging. These systems aim to streamline exams and enhance di

19-04-2024

Intuitive’s introduction of new da Vinci 5 robot steals Q1 spotlight

Intuitive Surgical saw strong growth in robot procedures and system placements in Q1, but the focus of the earnings call was on the launch plans for the da Vinci 5 plat

13-04-2024

Simpson obtains FDA breakthrough device designation for Acolyte system

The Acolyte system assists in accurately placing guidewires and catheters within coronary vessels. Simpson Intervention's Acolyte Image Guided Crossing and Re-Entry Cat

12-04-2024

FDA extends import alert to block all plastic syringes from Chinese manufacturer

The FDA enforces import alerts to enable the detention of products without physical examination, typically when a company is found to violate good manufacturing practic

12-04-2024

MMI receives de novo nod for microsurgery robot

Medical Microinstruments (MMI) secured de novo authorization for its Symani Surgical System, assisting surgeons in reconnecting small blood vessels. The FDA cleared the

12-04-2024

Kalogon launches custom wheelchair cushion Orbiter Med

Kalogon's Orbiter Med is a bespoke wheelchair cushion catering to individual seating needs. Approved by the Centers for Medicare & Medicaid Services (CMS) under HCP

12-04-2024

Getinge received EU MDR certification for Advanta V12 stent

Getinge has obtained the European Union (EU) Medical Device Regulation (MDR) certificate for its Advanta V12-covered stent system, confirming compliance with EU standar

09-04-2024

Smiths Medical recalls thousands of ventilators due to fault linked to 8 serious injuries

Healthcare professionals rely on gas-powered portable ventilators for oxygen administration in various settings, including during transportation and at accident scenes.

09-04-2024

FDA grants de novo nod to AI tool for sepsis detection

Prenosis secured de novo clearance for a predictive tool assessing sepsis risk within 24 hours, featuring a prioritized list of influencing parameters. Sepsis, a severe

09-04-2024

Eko wins FDA nod for AI to detect signs of heart failure using stethoscope

Eko Health received 510(k) clearance for a stethoscope feature detecting a heart failure indicator during routine exams. In primary care, echocardiography and other tra

09-04-2024

Teleflex catheterization kit recall due to 10 injuries, 1 death

Teleflex is recalling about 335,000 catheterization kits in the U.S. following the Food and Drug Administration's announcement of an issue linked to 10 injuries and one

09-04-2024

Baxter secures FDA clearance for delayed Novum IQ infusion pump

Baxter has secured 510(k) clearance for its large-volume infusion pump (LVP) Novum IQ after a three-year process with the FDA.

Init

31-03-2024

FDA re-issues ban on electric shock devices

In January, human rights groups urged the FDA and the Department of Health and Human Services to promptly release a proposed ban on electric shock devices, now that Con

31-03-2024

Abbott receives a CE mark for the 6-year insertable cardiac monitor

Competition in insertable cardiac monitors (ICMs) has surged recently. Boston Scientific debuted Lux-Dx ICM's initial version in Europe in 2022 and gained U.S. clearanc

30-03-2024

HCG designs a Patient App, to enable seamless access to doctors and medicines

HealthCare Global Enterprises Ltd., India's largest cancer care network, introduces the HCG Care app, a groundbreaking tool in oncology care. Developed in collaboration

30-03-2024

IIT Madras designs customizable, indigenous electric standing wheelchairs: NeoStand

IIT Madras has unveiled NeoStand, India’s most adaptable electric standing wheelchair, catering to the needs of wheelchair users. NeoStand features a compact desi

30-03-2024

Neuronetics received FDA clearance for the device to treat depression in adolescents

During an August earnings call, Neuronetics announced submitting a 510(k) application to expand Neurostar transcranial magnetic stimulation (TMS) device's eligible popu

28-03-2024

J&J Medtech, Nvidia associate to bring AI to the operating room

Researchers advocate for AI integration in surgery to aid navigation, enhance surgical robots, and refine operations, with companies like Intuitive Surgical already imp

26-03-2024

Deka’s automated insulin delivery system, powered by a patient-led app, acquires FDA clearance

Tidepool, a nonprofit born from grassroots efforts by diabetes patients, obtained 510(k) clearance for Tidepool Loop in early 2023, allowing users to pair preferred ins

26-03-2024

Abiomed’s latest Impella recall related to 129 injuries, 49 death reports

Abiomed recalled its Impella pumps due to the risk of catheter rupture through the left ventricle wall, posing serious health risks, per the FDA. Over 66,000 devices di

26-03-2024

Vyaire Medical recalls Airlife resuscitators over defect connected to 2 death reports

In January, Vyaire advised customers and distributors to discard Airlife manual resuscitators made in 2017 or earlier or lacking a manufacturing date. Though the fault

23-03-2024

Aster MIMS Kozhikode collaborates with Qure.ai to implement an AI-powered stroke care solution

Aster MIMS Hospital in Kozhikode has partnered with Qure.ai, a provider of AI solutions for medical imaging, to enhance stroke care and diagnosis. This collaboration in

23-03-2024

Fujifilm India inaugurates Open MRI machine in Hyderabad at Vijaya Diagnostic Centre

Fujifilm India has introduced its advanced Open MRI machine, "APERTO Lucent," at Vijaya Diagnostic Centre, India’s leading B2C diagnostic chain, enhancing access

18-03-2024

Abbott recalls the Heartmate LVAD communication system

Abbott issued a recall for a communication system that monitors heart failure patients implanted with its Heartmate 3 left ventricular assist device (LVAD) because of t

18-03-2024

Intuitive gets FDA clearance for new da Vinci robot

Intuitive Surgical has obtained 510(k) clearance from the Food and Drug Administration for its fifth-generation robotic surgery system, aimed at maintaining its leading

16-03-2024

Volta Medical’s AF-Xplorer obtains a CE Mark as per European Medical Device Regulation MDR 2017/745

Volta Medical, a leading health tech company, has obtained CE Mark for its Volta AF-Xplorer under the new European Medical Device Regulation MDR 2017/745. This AI tool

16-03-2024

Medtronic recalls more than 45,000 catheter tubing units following injury reports

Medtronic is recalling over 45,000 cerebrospinal fluid (CSF) drainage and sampling tubes in the U.S. due to issues linked to 26 injuries. The FDA categorized the recall

15-03-2024

Royal Philips presents an AI-enabled CT 5300 system equipped with advanced capabilities

Royal Philips, a leader in healthcare technology, launches the Philips CT 5300 system with advanced AI capabilities for diagnostics, interventions, and screenings. This

07-03-2024

US FDA marketing authorization for miniaturized robotic-assisted surgery device: Virtual Incision

Virtual Incision, a subsidiary of cultivate (MD), has received marketing authorization from the US FDA for the MIRA Surgical System (MIRA), marking a significant milest

07-03-2024

Digital app improves speech in stroke patients: NIHR study

A recent NIHR-supported study highlights the effectiveness of iTalkBetter, a digital platform that improves speech for those with aphasia. Developed by the Neurotherape

07-03-2024

Fujifilm India embarked on Echelon Synergy at CT & MRI User Conclave

Fujifilm India introduced the Echelon Synergy MRI Machine during its CT & MRI User event, focusing on the future of CT and MRI technologies. This system incorporate

06-03-2024

Sanskritech introduces CDSCO-approved ultra-portable anytime health monitoring bag: Swandook

Sanskritech, an Indian health-tech company backed by Mylab, has launched Swandook, an innovative health monitoring bag approved by CDSCO. It's touted as the world's fir

06-03-2024

MGI Tech, Eurofins Genomics associate to advance precision health with revolutionary DNBSEQ-T20×2 sequencer and affiliated technologies

MGI Tech, a leader in life science tools, has partnered with Eurofins Genomics Europe Genotyping A/S (Eurofins Genomics). Eurofins Genomics placed the first corporate o

01-03-2024

Volta Medical’s AF-Xplorer obtains CE Mark as per European Medical Device Regulation MDR 2017/745

Volta Medical has obtained the CE Mark for its Volta AF-Xplorer under the new European Medical Device Regulation MDR 2017/745, allowing sales in the European Union. Thi

29-02-2024

US FDA clearance to Zimmer Biomet’s ROSA Shoulder System for robotic-assisted shoulder replacement surgery

Zimmer Biomet Holdings, Inc., a global medical technology leader, has gained FDA clearance for its ROSA Shoulder System, marking it as the world's premier robotic surge

29-02-2024

Fujifilm India creates its first installation with endoscopic ultrasound machine Aloka Arietta 850 at Fortis Hospital

Fujifilm India has installed its first Aloka Arietta 850 endoscopic ultrasound system (EUS) at Fortis Hospital, Bengaluru, aiming to enhance treatment for patients with

29-02-2024

Philips’ high-powered & fast motorized mobile C-arm, Zenition 90 enables surgeons provide high-quality patient care

Philips has introduced the Image Guided Therapy Mobile C-arm System 9000 – Zenition 90 Motorized, enhancing surgical care accessibility. Tailored for intricate va

28-02-2024

US FDA awards humanitarian device exemption approval to SeaStar Medical’s Selective Cytopheretic Device for paediatric acute kidney injury

SeaStar Medical Holding Corporation, a leader in medical technology, announces FDA approval of the Selective Cytopheretic Device (SCD) Paediatric (SCD-PED) under a Huma

22-02-2024

Getinge bolsters commitment to Indian healthcare as it unveils Servo-c ventilator

Getinge, a global leader in medical technology, has introduced its cutting-edge Servo-c mechanical ventilator to the Indian market, catering to diverse respiratory need

19-02-2024

MIVI seeks FDA approval for stroke catheter as trial fulfils primary endpoint

MIVI Neuroscience showcased encouraging results at the 2024 International Stroke Conference in Phoenix, Arizona, USA, in February. They have submitted data to the US Fo

19-02-2024

Widex brings SmartRIC devices for natural hearing

Widex has launched the WidexSmartRIC hearing aid, aiming to improve natural hearing. Its unique L-shaped design optimizes microphone placement for better speech capture

19-02-2024

Exactech and Statera collaborate to design smart reverse shoulder implants

Exactech, based in the US, collaborates with Canadian medical device developer Statera Medical to innovate the world’s first smart reverse shoulder implant. This

19-02-2024

IntuiTap’s VerTouch device acquires US FDA approval

IntuiTap Medical has gained approval from the US Food and Drug Administration (FDA) for VerTouch, its handheld imaging tool. This FDA clearance confirms the device's sa

15-02-2024

Philips blocks sale of sleep, respiratory devices in the US for FDA consent decree

Philips has agreed to cease selling new sleep therapy and respiratory care products in the U.S., following a significant recall launched about two-and-a-half years ago.

15-02-2024

Metropolis collaborates with Singapore-based AI solutions provider ‘Qritive’ to revolutionize cancer detection

Metropolis Healthcare, India’s top diagnostic service provider, partners with Qritive, a global AI solutions leader for pathology labs, to bolster cancer diagnosi

15-02-2024

Aster CMI Hospital’s neurology department devises AI Carpal Tunnel Syndrome to detect median nerve in ultrasound videos

Aster CMI Hospital emerges as a leading advocate for healthcare AI, pioneering innovative technology to support medical professionals in various treatment aspects. It i

15-02-2024

StimLabs’ Corplex P, a human umbilical cord-derived medical device, receives US FDA 510(k) approval

StimLabs, founded in 2015 to advance regenerative medicine, announces FDA clearance of Corplex P, a groundbreaking medical device derived from human umbilical cord tiss

12-02-2024

Edwards acquires FDA clearance for first transcatheter tricuspid valve replacement treatment.

Edwards Lifesciences has gained FDA approval for its Evoque tricuspid valve replacement system, marking a significant advancement as the first transcatheter treatment f

10-02-2024

FDA receives additional reports of casualties linked to Philips’ recalled respiratory devices

The Food and Drug Administration (FDA) has observed a surge in medical device reports (MDRs) concerning Philips’ respiratory products, including instances of fata

09-02-2024

Fresenius brings dialysis technology to the US with FDA approval

Fresenius Medical Care announced 510(k) clearance for its 5008X Hemodialysis System, a high-volume hemodiafiltration dialysis therapy device using diffusion and convect

08-02-2024

Insulet acquires CE mark for integration of insulin pump with Abbott CGM

Insulet has secured a CE mark for integrating its Omnipod 5 insulin pump with Abbott’s Freestyle Libre 2 Plus continuous glucose monitor (CGM) sensor. This cleara

07-02-2024

Hologic wins FDA approval for AI-enabled cervical cancer screening system

Hologic has gained regulatory approval to sell an AI-powered cervical cancer screening system in the U.S. Named the Genius Digital Diagnostics System, it digitizes Pap

07-02-2024

Boston Scientific’s spinal cord stimulators endorsed for non-surgical back pain

Boston Scientific's Wavewriter spinal cord stimulator (SCS) systems have gained FDA approval for non-surgical back pain (NSBP) management. This expands the label to inc