Vuno Inc. has received its third breakthrough device designation from South Korea’s Ministry of Food and Drug Safety (MFDS), for its artificial intelligence (AI)-based electrocardiogram (ECG) analysis software Vuno Med DeepECG. Vuno is the first company to have three such designations to its name. “We developed Vuno Med DeepECG via long-term ECG data analysis research. With this breakthrough designation, we target expanding our market share in the medical AI industry via our bio-signal businesses. Among these is ECG data, which can help diagnose various heart diseases and has high potential,” Yeha Lee, chairman at Vuno, told BioWorld.
The FDA granted Cardialen Inc. an investigational device exemption (IDE) to begin a clinical trial of its Multipulse Therapy (MPT) to treat paroxysmal and persistent atrial fibrillation (AF). MPT is a low-energy electrical pulse therapy aimed at restoring abnormally rapid heart rates, such as AF, to a regular rhythm to reduce the potential for high-energy shocks. Studies have shown that almost 1 in 4 patients experience anxiety or depression after receiving an implantable cardioverter defibrillator (ICD).
PARIS – Incepto Medical SAS, in partnership with Marie-Lannelongue Hospital, is developing an automated system to measure maximum aorta diameter. Called ARVA (Augmented Radiology for Vascular Aneurysm), it’s hosted in the cloud and is CE marked as a class I device. “Our tool uses the first algorithm to provide automatic measurement of external aortic diameter along the entire aorta, from ascending aorta to the iliac arteries,” Antoine Jomier, co-founder and CEO of Incepto, told BioWorld. This new tool for radiologists and surgeons will be used to diagnosis and monitor aneurysms.
Shares of cardiac diagnostics company Heartbeam Inc. (NASDAQ:BEAT) are trading lower than expected after it opened on the Nasdaq on Nov. 11. The digital health company priced its public offering of 2,750,000 units at $6, but as of midday, shares were trading at $4.56. It’s a disappointing start for the Santa Clara, Calif.-based company, which is developing an ECG telemedicine technology to diagnose cardiovascular patients for ambulatory settings.
Endovascular stent grafts for abdominal aortic aneurysms don’t generate the fanfare that other circulatory system devices create, but an FDA advisory panel recently made some extensive recommendations regarding postmarket follow up for these devices.
PARIS – Royal Philips NV has signed a deal to acquire Cardiologs Technologies SAS and its artificial intelligence technology. The financial terms surrounding the transaction have not been disclosed. The two companies expect to close the deal in the coming months.
Ultrasound companies, Caption Health Inc. and Ultromics Ltd. are linking up to jointly offer Caption’s AI software platform with Ultromics’ Echogo deep ultrasound analytics for cardiovascular disease detection.
Two studies presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference directly compared Boston Scientific Corp.’s Watchman 2.5 and Watchman Flx to Abbott Laboratories’ Amplatzer Amulet device. Both showed Amulet had less than half as many leaks, but the clinical impact of the lower rate remained unclear.
Catheter-based delivery of replacement valves is established practice for patients with aortic regurgitation, but the mitral valve has only repair devices to address this condition. However, transcatheter mitral valve replacement (TMVR) devices by Dublin-based Medtronic plc., and triscupid valve replacement devices by Edwards Lifesciences Inc. of Irvine, Calif., made some noise at this year’s edition of Transcatheter Cardiovascular Therapeutics (TCT), suggesting that these patients might soon have a wider range of options.
The U.K. National Institute for Health and Care Excellence said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp. (BSX), are ready for prime time in the U.K. national health system.
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