(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)
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 |