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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dexcom's G7 CGM

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Init

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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