The Latest Cardiac and Vascular News
FREMONT, Calif., July 17, 2019 /PRNewswire/ — Q’Apel Medical announced today that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC). In the neurovascular space where speed, reliability and performance are so critical to patient outcomes, physicians and patients demand that innovative technologies are best-in-class. The walrus BGC, […]
SAN DIEGO, July 16, 2019 /PRNewswire/ — Ambrx Inc. today announced that Bristol-Myers Squibb Company (“BMS”) has initiated a phase I clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of long-acting Relaxin for the potential treatment of heart failure (“HF”). Long-acting Relaxin is an investigational biologic produced using Ambrx’ proprietary expanded genetic code […]
BOSTON, July 16, 2019 /PRNewswire/ — Biofourmis, a fast-growing global leader in digital therapeutics, has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). Biofourmis’ mobile platform BiovitalsHFTM will be leveraged in a study of patients with heart failure to monitor functional capacity and quality of life […]
Pending U.S. Food and Drug Administration (“FDA”) Humanitarian Use Device (“HUD”) Classification and Approval as a HUD, Company Expects to Begin Commercializing Reducer in U.S. by Early 2020 A potential HUD Reducer designation for Canadian Cardiovascular Society (“CCS”) Class IV would, by statute, allow the treatment of a limited number of […]
PETAH-TIKVA, Israel, July 16, 2019 /PRNewswire/ — Leviticus Cardio today announced the appointment of Prof. Mandeep R. Mehra to its Scientific Advisory Board. “We are very excited that Prof. Mehra has joined our Scientific Advisory Board. He is recognized as one of the world’s leading cardiologists in advanced heart failure and cardiac transplantation, and he will provide immediate […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. Derived from more than 20 years of life support experience with TandemLife, LifeSPARC […]
Westport, CT, July 15, 2019 (GLOBE NEWSWIRE) — 1) New units to be prepped for next phase of targeted commercial launch strategy 2) Company includes 3 additional hospitals to its list of medical institutions for delivery in 2019 to demonstrate the technology 3) Proprietary device is designed to record and display […]
LISLE, Ill., July 15, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial, in Europe. The 60-patient study will evaluate safety and efficacy of the Cordella™ Pulmonary Artery Pressure Sensor System […]
Filterlex won the best innovation award at the EuroPCR 2019 conference in Paris and was awarded $200,000 prize by the Jon DeHaan Foundation YOKNEAM, Israel, July 15, 2019 /PRNewswire/ — Filterlex Medical is a medical device start-up company, developing an innovative embolic protection device (CAPTIS) for reducing the risk of stroke and other complications during catheter-based structural heart procedures. […]
WHIPPANY, N.J., July 15, 2019 /PRNewswire/ — Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadavist is […]
