This article has been updated with a response from Boston Scientific. The FDA is apparently allowing medtech companies to submit incomplete reports of device-related deaths, according to a new report by the StarTribune of Minneapolis. The news article says that the agency accepted one summary report covering four deaths related to Boston Scientific’s (NYSE:BSX) Watchman […]
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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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
Latest Cardiology News
InCarda Therapeutics raises $35 million
InCarda Therapeutics — which is developing an inhaled paroxysmal atrial fibrillation drug — filed an SEC Form D confirming the sale of more than $35 million in equity. The Newark, Calif.–based drug-device combo company sold nearly $35.3 million since the first sale of the offering occurred on Oct. 20, 2017, according to yesterday’s filing. InCarda […]
Edwards’ Sapien 3 TAVI wins expanded approval in Europe
Edwards Lifesciences (NYSE:EW) said today that it received CE Mark approval for expanded use of its Sapien 3 transcatheter aortic valve implantation (TAVI) system. The expanded use if for treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 TAVI is the first transcatheter heart valve system to win […]
Okami Medical wins FDA clearance for vascular occlusion system
Okami Medical yesterday said it won FDA 510(k) clearance for its LOBO Vascular Occlusion System. The Low-Profile Braided Occluder (LOBO) system helps patients and physicians with the occlusion of peripheral blood vessels. The system uses HDBraid technology to give physicians a minimally invasive platform for rapid and focal occlusion of a wide range of arterial […]
Abbott recall of CentriMag circulatory support system designated as Class I
Updated Nov. 6 after FDA edited its notice to update on injury and fatality numbers. The U.S. FDA today issued a Class I designation — its most serious — over Abbott’s recall of its CentriMag circulatory support system. By the time Abbott (NYSE:ABT) initiated a recall in August 2019, there were already reports 44 injuries related […]
Boston Sci fires back at judge who imposed sanctions
Boston Scientific (NYSE:BSX) has angrily responded to a judge’s recent sanctions in a whistleblower lawsuit lodged over two of its cardiac rhythm management devices. In an Oct. 16 ruling, Judge Steven Rau lambasted the company for using “shenanigans” in slow-rolling the discovery process. The lawsuit accuses Boston Scientific of defrauding the FDA by not reporting […]
Neovasc to pursue PMA this year for Reducer
Neovasc (NSDQ:NVCN) said today that it plans to seek pre-market approval from the FDA for its Reducer angina device by the end of the year. In July, Vancouver-based Neovasc said it hoped the get the device on the U.S. market in early 2020 via a humanitarian device exemption. Reducer is designed to narrow the coronary sinus […]
AliveCor inks wearables deal with Huami
AliveCor said yesterday that it entered into a strategic partnership with Huami Corp. (NYSE:HMI) to combine each company’s technologies for developing medically functional wearable devices. The financial details of the agreement were not disclosed but the company said the agreement includes the licensing of AliveCor technology and a deal to bring new devices and services to […]
Abiomed jumps on fiscal Q2 earnings beat
Abiomed (NSDQ:ABMD) shares got a pre-market jump today from fiscal second-quarter earnings that topped the consensus forecast once some $35 million in unrealized losses from its stake in Shockwave Medical (NSDQ:SWAV) were factored in. The Danvers, Mass.-based heart pump maker posted profits of $13.1 million, or 28¢ per share, on sales of $205.0 million for […]
Cardiovascular Systems sinks on fiscal Q1 earnings miss
Cardiovascular Systems (NSDQ:CSII) shares sank today after the medical device company missed the consensus earnings forecast for its fiscal first quarter.* Th St. Paul, Minn.-based company doubled its losses to -$5.8 million, or -17¢ per share, on sales growth of 14.6% to $64.5 million for the three months ended Sept. 30, compared with fiscal Q1 2019. […]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” Get the full story at our sister site, […]