LifeWatch (SWX:LIFE) said yesterday that it won 510(k) clearance from the FDA for its mobile cardiac telemetry patch, a 1-lead electrocardiograph system. Zug, Switzerland-based LifeWatch said the MCT 1-lead patch is capable of “watching every heartbeat for adverse cardiac events and transmitting significant findings, in near-real time, to a clinical service center.” “I am very excited about […]
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
FDA sets panel date for Angel Medical’s implantable cardiac monitor
The FDA is slated to convene an advisory panel meeting to discuss Angel Medical Systems’s pre-market approval application for the AngelMed Guardian implantable heart monitor, the agency said today. The FDA’s Circulatory System Devices Panel is due to meet March 16 to discuss the PMA for the AngelMed Guardian, which is designed to detect the early heart problems […]
Abbott wins FDA panel date for Absorb GT1 bioabsorbable stent
The FDA said today that 1 of its advisory panels is due to convene for a hearing on the Absorb GT1 bioabsorbable stent developed by Abbott (NYSE:ABT). The federal safety watchdog’s Circulatory System Devices Panel is slated to meet March 15 for a vote on Abbott’s pre-market approval for the Absorb GT1 device, a coronary scaffold that’s […]
Prospects for proxy war heat up at HeartWare
HeartWare International (NSDQ:HTWR) is facing another potential proxy battle after a 2nd activist investor firm took out a stake in the implantable heart pump maker. Last month Engaged Capital, which owns about 1.3% of Framingham, Mass.-based HeartWare, said it’s prepared to launch a proxy war over the proposed acquisition of Israeli replacement heart valve maker Valtech Cardio. Engaged […]
Edwards Lifesciences wins FDA nod for new Sapien 3 trial
Edwards Lifesciences (NYSE:EW) said today that the FDA approved a new trial of its Sapien 3 replacement heart valve. The Sapien 3 transcatheter aortic valve replacement was approved last year by the federal safety watchdog for patients at high risk of death from open surgical procedures to replace their aortic valve. The new investigational device exemption […]
Imricor wins CE Mark for MR-conditional recording system
Imricor Medical Systems said today it won CE Mark approval in the European Union for its Advantage-MR EP recorder/stimulator system, designed to allow for MRI-guided electrophysiology procedures. The system, along with MR-compatible ablation catheters, will allow operating physicians to perform cardiac ablations using real-time MRI guidance, which the Minneapolis, Minn.-based company said could improve safety […]
Conavi wins 510(k) for cardiac ultrasound imager
Conavi medical said today it won FDA 510(k) clearance for its Foresight ICE System designed for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy. The device from Toronto-based Conavi, formerly known as Colibri Technologies, also allows for the visualization of other devices in the heart and great vessels of patients, the company […]
Boston Scientific CMO Dawkins: Rivals spent $1.5B on 80 patients and half are dead
Medical device acquirers spent something in the neighborhood of $1.5 billion over the past few months on transcatheter mitral valve replacement acquisitions to treat just 80 patients, half of whom are now dead, Boston Scientific (NYSE:BSX) chief medical officer Dr. Keith Dawkins said today. “There’s been, really [since] a few months ago, $1.5 billion, roughly, spent […]
Update: PE shop Aurora Capital buys Cardiac Science
Update: Added legal information on the bankruptcy sale Private equity firm Aurora Capital Group said today it acquired the assets of Cardiac Science in a court-approved sale. The buy was approved by U.S. Bankruptcy Judge Robert Martin, and included a $65 million credit bid and an agreement from Aurora to take on other liabilities including real […]
St. Jude Medical rejiggers sales reporting
St. Jude Medical (NYSE:STJ) said today that it plans to rejigger the way it reports its sales to better reflect its focus in managing the business, beginning this year. Little Canada, Minn.-based St. Jude, which saw its share price slide today after missing forecasts for its 4th-quarter sales, said it’s focus is shifting to 5 key key areas: Heart failure; atrial […]
J&J joins Edwards in $28m Series B for arterial shunt dev V-Wave
Johnson & Johnson (NYSE:JNJ) joined previous investor Edwards Lifesciences (NYSE:EW) in a $28 million Series B round to support heart failure treating interarterial shunt maker V-Wave, according to a press release posted yesterday. Other groups joining the round included newly-invested TriVentures, Pura Vida Investments and BioStar Ventures, with returning investors Pontifax and the BRM group. “With the […]