The FDA this week approved Angel Medical Systems AngelMed Guardian implantable cardiac monitor system after the device had previously been rejected unanimously by an FDA advisory panel in 2016. The initial rejection came after the Tinton Falls, N.J.-based company presented partial data from its pivotal trial of the device in after having pulled the plug […]
HeartStitch wins CE Mark for CoAp Pro mitral valve repair device
HeartStitch said today it won CE Mark approval in the European Union for its CoAp Pro device designed for mitral valve remodeling and repair. The Fountain Valley, Calif.-based company said its CoAp Pro device is designed to allow physicians to remodel mitral valve leaflets to re-establish proper coaptation. “I am especially pleased to see HeartStitch receive […]
20 medical device startups you need to know
There’s a lot of excitement these days around digital health. But there are actually many medical device startups out there in other spaces that continue to push the overall boundaries of medtech. From neuromodulation to drug delivery, surgical robotics and more, here’s a roundup of 20 medical device startups catching the eye of Medical Design […]
CMS approves expanded MRI coverage for CRM patients
The Centers for Medicare & Medicaid Services have finalized a plan that will cover magnetic resonance imaging scans for patients with implanted cardiac devices, including pacemakers, cardioverter defibrillators and cardiac resynchronization therapy devices, according to a MedPage Today report. The finalized decision, which was released in January, will allow Medicare patients with MR-conditional devices to […]
HeartStitch wins CE Mark for Trans-Apical Access and Closure device
HeartStitch said today it won CE Mark approval in the European Union for its suture-based Trans-Apical Access and Closure device. The Trans-Apical Access and Closure device is designed to provide percutaneous trans-apical access for structural heart procedures and closures. The system emulates surgical closure without need for open heart surgery or limited thoractomy access during left-heart […]
Murj launches OnSite cardiac device management workflow platform
Murj said today it launched the OnSite cloud-based in-office cardiac device management workflow platform. The OnSite software is an extension of the company’s remote transmission management workflow products, and combines both in-office visits and remote transmissions into a single longitudinal patient view, Santa Cruz, Calif.-based company said. “Our mission is to empower clinicians with newfound insight […]
Abbott launches study comparing OCT to angiography in stent placement procedures
Abbott (NYSE:ABT) today announced the launch of new trial exploring long-term outcomes in patients who underwent stent implantation guided by optical coherence tomography as compared to angiography. The first patient in the trial was enrolled by Dr. Franco Fabbiocchi at Milan, Italy’s IRCCS Centro Cardiologico, the Abbot Park, Ill.-based company said. “Today, most of the world […]
HeartSciences touts MyoVista LVDD study
HeartSciences today released results from a clinical study of its MyoVista electrocardiogram system, touting its ability to detect myocardial relaxation abnormalities associated with left ventricular diastolic dysfunction. Results from the trial were published in the Journal of the American College of Cardiology, the Southlake, Texas-based company said. “This study of MyoVista wavelet ECG technology is […]
HeartStitch touts tricuspid repair feasibility cases
Structural heart focused medtech company HeartStitch said today that its HeartStitch Remo Pro suture technique was used in a world first procedure to repair the tricuspid valve of two patients as part of a feasibility trial of the technique and the supporting technology. The procedures were performed by Dr. Yuri Pya at Astana, Kazakhstan’s National Research […]
How CHF Solutions is using health economics to expand product adoption
Two years after CHF Solutions (NSDQ:CHFS) acquired Baxter‘s (NYSE:BAX) Aquadex fluid filtration device for $5 million, the company’s executives are working to weave together the evidence they need to land reimbursement in the U.S. and expand patient access for its technology. The Aquadex system is designed to filter water and salt from patients experiencing fluid overload due […]
Renal denervation: Medtronic wins FDA nod for U.S. pivotal trial
Medtronic (NYSE:MDT) said today that it won an investigational device exemption from the FDA for a pivotal trial of its Symplicity Spyral renal denervation device for treating high blood pressure. Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the nerves around the […]
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