Masimo has received FDA 510(k) clearance for its medical watch for both over-the-counter and prescription use. The FDA clearance is the latest good news for Masimo, which has been making headway in its patent battle with tech giant Apple. MASI shares were up more than 1% to $94.75 apiece by midday trading today on the […]
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Cardiac Implants | Structural Heart | Pulsed-Field Ablation
Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
FDA approves Medtronic’s Symplicity Spyral renal denervation system
Medtronic today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic is now the second company with premarket approval (PMA) to market an RDN system for hypertension in the U.S., following Recor Medical’s approval earlier this […]
Element Science has positive data for patch-wearable defibrillator
Element Science announced positive data from a study of its Jewel patch-wearable cardioverter defibrillator (P-WCD). The FDA investigational device exemption evaluated Jewel for sudden cardiac arrest (SCA) prevention across 305 patients. San Francisco-based Element Science developed Jewel with patient experience in mind, creating a low-profile, lightweight design. The water-resistant device allows patients to comfortably wear […]
Teleflex enrolls first patient in registry of vascular closure device for TAVR
Teleflex announced today that it enrolled the first patient in a clinical registry evaluating its Manta vascular closure device (VCD). The company aims for the registry to examine and collect data on outcomes of contemporary on-label use of Manta in standard of care transcatheter aortic valve replacement (TAVR) procedures. It includes appropriate patient selection and […]
Inari Medical closes LimFlow acquisition
Inari Medical announced that it completed its acquisition of chronic limb-threatening ischemia (CLTI) treatment maker LimFlow. The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to $415 million. The deal came just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough CLTI treatment. Inari Medical intends to […]
Eko reports improved heart disease detection with its AI tech
Eko Health today announced new clinical data demonstrating the real-world clinical efficacy of its AI-enabled Sensora platform. Data presented at the 2023 American Heart Association Scientific Sessions highlighted Sensora’s ability to quickly and accurately detect structural murmurs associated with valvular heart disease. The study evaluated the performance of an Eko digital stethoscope paired with the […]
Boston Scientific has more positive Farapulse pulsed-field ablation data
Researchers shared positive data from a large, real-world registry of patients treated with the Boston Scientific Farapulse system. Data from more than 17,000 patients in the MANIFEST 17K registry reinforced the real-world safety profile for the pulsed-field ablation (PFA) system. Results included no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury. […]
Recor Medical launches renal denervation system, announces first commercial cases
Recor Medical announced the first commercial uses of its Paradise ultrasound renal denervation (uRDN) system for treating hypertension. The first commercial uses follow the company’s landmark FDA approval for Paradise last week. Approval allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to control a patient’s blood […]
Elucid raises $80M Series C for AI-powered imaging analysis software
Elucid announced today that it raised $80 million in a Series C funding round to support its AI-powered imaging analysis software. Boston-based Elucid says the funding could help to expand its commercialization efforts. With a $27 million Series B raised last year, the company has now raised $121 million in total since inception. Elevage Medical […]
Acutus Medical is laying off more than half of its workers
Acutus Medical (Nasdaq:AFIB) announced today that it will lay off 65% of its workforce as part of a major restructuring. The Carlsbad, California–based company’s most recent annual report lists 225 workers at the end of 2022, which means the layoff could involve roughly 146 workers. Restructuring will involve winding down Acutus Medical’s EP mapping and […]
Intracardiac pressure monitoring device startup Acorai raises €2.3M
Acorai announced today that it received a $2.5 million (€2.3 million) grant to support its non-invasive intracardiac pressure monitoring system. The European Innovation Council (EIC) selected Helsingborg, Sweden-based Acorai for the grant. It also features a follow-on investment offer worth $10.7 million (€10 million) for the maximum funding amount. Acorai develops a first-of-its-kind device aimed […]
