01-10-2024 EU drug regulator authorise use of Bavarian Nordic's mpox vaccine, Imvanex for adolescentsBavarian 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 toolThe 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 LyumjevTandem 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 injuriesSmiths 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 AlexaA 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 EuropeRoche 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 techSiemens 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 tubesSmiths 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 AirpodsThe 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 environmentRoche 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 USAbbott 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.1Moderna, 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 acceleratorJohns 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 pumpEmbecta (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 systemAngioDynamics (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 fermentersVFL 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 technologyApotek 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 technologyBoston 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 FDANovavax, 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-DxQiagen 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 riskGSK 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 diseaseScientists 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) 2024Qure.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 systemAccuray 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 SystemPROCEPT 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 diabetesThe 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 useNOWDiagnostics, 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 outbreakRoche 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 HealthRenown 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 validationBeurer 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 deviceFractyl 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 patchHuxley 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 technologyIn 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 issuesSmiths 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 platformJohnson & 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 implantMiRus, 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 therapyInspire 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 systemTerumo 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 technologyRetrieve 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 guidewireHaemonetics 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 woundsMiMedx 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 SystemJohnson & 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: AliveDxAliveDx, 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 systemMiRus, 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 testImmunovia, 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 scannerMahajan 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 glaucomaViaLase, 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 adultsThe 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 subcutaneouslyOneSource 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 statusRestore 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, NeuroLFPositrigo, 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 RegulationInspire 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 diseaseHeartFlow, 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 vaccineNew 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 diseasesBD (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 restartHamilton 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 diseaseHeartFlow 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 injuriesPhilips 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-testThe 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 CGMRoche 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 injuriesPhilips 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 platformMedprime 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 riskThe 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 deviceFischer 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 manufacturingTrivitron 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 smartwatchesZepp 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 riskJohnson & 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 clearanceSignum 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 toolsAvicenna.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 upgradesCarestream 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 systemA 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 solutionInsign 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 testingIndia-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 injuriesPhilips 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 deviceDeveloped 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 ADAEmbecta 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 salesSenseonics 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 sepsisMagnolia 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 robotMeril, 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 ShenliMerit 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 deathsTeleflex 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 ChinaCardinal 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 robotGlobus 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 devicesThe 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 IndiaFischer 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) clearanceInspira 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 pacemakerAbbott 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 robotMoon 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 USApple 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 errorMedtronic 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 problemPhilips 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 SystemAvita 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 injuriesHologic 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 toolMarinHealth 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 IThe 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 useInnoVoyce'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 deathRoute 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 IVyaire 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 certificationTeltonika, 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 baseplatesFX 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 kitBD 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 reportsJohnson & 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 cathetersBoston 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 AccessoryClearPoint 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 robotsStereotaxis, 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 reportedAbbott 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) clearanceThe 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 salesOutset 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 prescriptionMasimo 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 ChinaMedtronic 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 hydrocephalusThe 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 systemUnited 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 detectionOptomed 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 solutionGE 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 pumpsSenseonics 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 deviceBrioHealth 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 diseaseThe 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 deathHealthcare 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 systemExo 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 scaffoldAbbott'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 riskIn 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 stimulatorMedtronic'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 toolLumisystem 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 devicesIn 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 softwareFounded 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 managementAtriCure 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 platformLumicell 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 systemsGE 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 spotlightIntuitive 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 systemThe 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 manufacturerThe 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 robotMedical 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 MedKalogon'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 stentGetinge 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 injuriesHealthcare 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 detectionPrenosis 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 stethoscopeEko 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 deathTeleflex 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 pumpBaxter 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 devicesIn 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 monitorCompetition 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 medicinesHealthCare 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: NeoStandIIT 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 adolescentsDuring 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 roomResearchers 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 clearanceTidepool, 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 reportsAbiomed 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 reportsIn 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 solutionAster 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 CentreFujifilm 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 systemAbbott 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 robotIntuitive 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 2017/745Volta 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 reportsMedtronic 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 capabilitiesRoyal 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 IncisionVirtual 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 studyA 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 ConclaveFujifilm 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: SwandookSanskritech, 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 technologiesMGI 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 2017/745Volta 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 surgeryZimmer 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 HospitalFujifilm 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 carePhilips 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 injurySeaStar 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 ventilatorGetinge, 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 endpointMIVI 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 hearingWidex 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 implantsExactech, 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 approvalIntuiTap 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 decreePhilips 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 detectionMetropolis 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 videosAster 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) approvalStimLabs, 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 devicesThe 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 approvalFresenius 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 CGMInsulet 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 systemHologic 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 painBoston 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 |
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