Berlin Heart announced today that it completed the post-approval surveillance process for its Excor pediatric ventricular assist device (VAD). Post-approval surveillance is a requirement of the post-market approval that Berlin Heart’s Excor received from the FDA in June 2017. The company’s final report to the FDA confirmed positive results in pediatric heart failure patients treated […]
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
Abiomed touts results of U.S. study of its latest Impella heart pump
Abiomed (NSDQ:ABMD) says a study of U.S. patients receiving the new Impella 5.5 with SmartAssist found that 84% survived to explant and 76% experienced native heart recovery. The study — published in the July edition of the American Society for Artificial Internal Organs (ASAIO) Journal — examined the outcomes of the first 55 patients treated with Impella […]
Kardium lands CE Mark for mapping and ablation device
Kardium announced that it received CE Mark approval in Europe for its Globe mapping and ablation system for treating atrial fibrillation (AF). Vancouver, B.C.-based Kardium’s spherical Globe catheter is comprised of 122 electrodes to provide electrophysiologists with single-shot pulmonary vein isolation, high-definition mapping and atrial ablation, according to a news release. Approval in Europe came […]
Ancora Heart wins IDE for ventricular restoration system
Ancora Heart announced today that it received FDA investigational device exemption (IDE) for its AccuCinch ventricular restoration system. AccuCinch is designed to treat patients with heart failure and reduced ejection fraction (HFrEF) by directly reshaping the left ventricle of the heart to address the fundamental issue in the progression of systolic heart failure, according to […]
Protaryx Medical raises $8.3m
Protaryx Medical announced today that it raised $8.3 million for the development of its first-in-class device for transseptal access to the left atrium. The Baltimore-based company’s funding includes non-dilutive grants and a seed round totaling $3.2 million, along with a recently closed $5.1 million Series A round led by Ajax Health, with participation from returning […]
CVRx reports positive six-month trial results for Barostim Neo
CVRx announced today that it observed positive six-month results from its BeAT-HF trial for the Barostim Neo device for improving symptoms of heart failure. Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery in an effort to restore balance to the automatic nervous system and improve […]
Philips HeartStart XL defibrillator therapy selector switch may fail
The United Kingdom issued a warning on potential failures with the therapy selector switch for the HeartStart XL defibrillator from Royal Philips (NYSE:PHG). According to a notice from the U.K. government, Philips’ defibrillator’s rotary therapy selector switch (energy select knob) may fail, resulting in unexpected device behavior that may include not switching on, not performing the […]
BioSig closes $17.5m offering
BioSig Technologies (NSDQ:BSGM) announced today that it closed a registered direct offering of common stock worth $17.5 million. The Westport, Conn.-based company and its majority-owned subsidiary, ViralClear Pharmaceuticals, sold nearly 2.2 million shares of common stock at $8 per share, closing the offering on June 26. Proceeds from the offering reached $17.5 million before deducting placement […]
Boston Scientific wins FDA clearance for insertable cardiac monitor
Boston Scientific (NYSE:BSX) today said it received FDA 510(k) clearance for its Lux-Dx Insertable Cardiac Monitor System. The system is a long-term diagnostic device that is implanted into patients to detect arrhythmias associated with atrial fibrillation, cryptogenic stroke and syncope. Lux-Dx is designed with a dual-stage algorithm that can detect and verify potential arrhythmias before sending […]
20 medical device startups you need to know
The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention. Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects. […]
$4.2m project with GE would develop air transport vital-signs patch
The Nano-Bio Materials Consortium (NBMC) announced this week that it has launched a project with GE Research to develop a medical-grade wireless patch that monitors the vital signs of medical patients during emergency air transport. The device would advance medical care coordination, records management and patient outcomes in aeromedical evacuation and help drive advances in consumer-based telehealth, according to […]