Getinge announced today that it received EU MDR certification for its Advanta V12 covered stent system for patients with aortoiliac occlusive disease (AIOD). The balloon-expandable covered stent’s indication aligns with AIOD, which includes treating lesions at the aortic bifurcation. Getinge said EU MDR certification highlights its dedication to providing safe, effective, high-quality products. With the […]
Raydiant Oximetry wins FDA IDE nod for fetal pulse oximeter
Raydiant Oximetry announced that the FDA granted investigational device exemption (IDE) to its Lumerah technology. IDE enables an early feasibility study evaluating the technology for pregnant women during labor and delivery. The company designed Lumerah to improve the detection of fetal distress during labor and delivery. A non-invasive, transabdominal fetal pulse oximeter, it measures the […]
Nectero Medical closes $96M Series D
Nectero Medical announced today that it closed a Series D financing round to support its abdominal aortic aneurysm treatment. Norwest Venture Partners led the round. Boston Scientific, BioStar Capital, Cadence Healthcare Ventures, Aphelion Capital and other firms contributed large investments to the $96 million money raise. The funds add to a $19.5 million Series C […]
Osso VR launches medical training app for Apple Vision Pro
Osso VR announced today that it launched Osso Health, a medical training app for use on the Apple Vision Pro system. The offering leverages the power of Apple Vision Pro to blend digital content with the physical world. Osso VR aims to bring the operating experience to live through detailed, clinically accurate workflows of common […]
Dexcom, MD Revolution partner to integrate CGM into remote care platform
MD Revolution today announced a partnership with Dexcom to integrate CGM into its remote care management platform. Dexcom develops continuous glucose monitoring technology (CGM), including its latest-generation G7. The system pairs with smartphones — and now Apple Watches — to monitor the glucose levels of people with diabetes. MD Revolution’s remote care management platform integrates […]
Shockwave Medical opens IVL production plant in Costa Rica that will add 1,200 jobs
Shockwave Medical (Nasdaq:SWAV) announced today that it opened a new production plant for its intravascular lithotripsy (IVL) technology in Costa Rica. The company shared news of the new plant, located in San José, in a post on LinkedIn. It marks another recent positive development for the company, which agreed to be acquired for $13.1 billion by […]
Illumina CFO departs, replacement named along with chief strategy officer
Illumina (Nasdaq:ILMN) announced that it appointed Ankur Dhingra as CFO following the departure of Joydeep Goswami. The company also announced the appointment of Jakob Wedel as chief strategy and corporate development officer. Its c-suite continues to undergo a makeover following the appointment of a new CEO last year amid its long-running battle to acquire Grail. Goswami, […]
Biotronik unveils new AI-powered insertable cardiac monitor
Biotronik announced that it received CE mark approval and completed the first European implant of its latest insertable cardiac monitor (ICM). The BioMonitor IV features AI capabilities for false positive reduction. The AI cuts false positives for AFib, bradycardia, tachycardia and pause. According to Biotronik, its SmartECG reduces 86% of false detections across all major […]
Medtronic unveils next-gen GI Genius software, partners with ModMed on AI-powered colonoscopy
Medtronic today announced advancements for its AI-powered GI Genius system, as well as a new collaboration. The company unveiled its ColonPRO latest-generation software for the GI Genius intelligent endoscopy system. GI Genius, a computer-aided polyp detection system powered by AI, has been available in the U.S. since 2021. Medtronic designed it to redefine GI screening by […]
Philips comes to consent decree agreement with DOJ, FDA over Respironics recall
Philips today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ). The consent decree primarily focuses on its Philips’ Pennsylvania-based Respironics business — the subject of a major recall over the past several years. That includes manufacturing facilities in Murrysville and New Kensington, a service center in […]
OM1, Medtronic partner on drug-eluting implant study
OM1 today announced positive results from its partnership with Medtronic (NYSE:MDT) evaluating the Propel corticosteroid-eluting implants. The Propel bioabsorbable implant family came to Medtronic through its acquisition of IntersectENT in 2022. OM1 and Medtronic partnered on their study to focus on healthcare resource use and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent […]