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