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 […]
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
Latest Cardiology News
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, […]
FDA clears HeartVista’s One Click AI-assisted cardiac MRI
HeartVista said today that it won FDA 510(k) clearance for its AI-assisted One Click MRI acquisition software for cardiac exams. The One Click system is designed to use AI-assisted software to prescribe the standard cardiac views with one click in as little as 10 seconds as the patient breathes freely. The system detects when images […]
Medtronic wins FDA breakthrough nod for fully implantable LVAD
Medtronic (NYSE:MDT) said today that it won breakthrough device designation from the FDA for its fully implantable heart pump. The Fridley, Minn.-based medical device giant said its left ventricular assist device is designed to be fully implanted inside the body, with no driveline extending outside the body. Medtronic said the device is still in the […]
Abbott plans $38m Mitraclip plant in Indiana
Abbott (NYSE:ABT) announced yesterday that it plans to spend close to $38 million to open a manufacturing plant for its Mitraclip system in Westfield, Ind. The proposed 120,000-square-foot facility in Westfield’s NorthPoint Industrial Park could cost more than $37.6 million and is slated to employ as many as 477 people by the end of 2024, according […]
Siemens Healthineers closes $1B Corindus Vascular Robotics buy
Siemens Healthineers said it today completed its $1.1 billion buyout of Corindus Vascular Robotics and its robot-assisted device for coronary and peripheral vascular procedures. Last week Corindus shareholders approved the merger, in which the German firm put up $4.28 per common share and $85.60 per Series A convertible preferred share. Today Siemens Healthineers said former […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]