CVRx has raised $50 million in its latest round of equity financing — money the company will use to support the U.S. commercialization of its Barostim Neo heart failure treatment device. New investors Strategic Healthcare Investment Partners and Vensana Capital led the new funding round — with participation from other new investors, Hatteras Venture Partners […]
Berlin Heart touts pediatric heart device post-approval performance
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 […]
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 […]
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. […]
Foldax closes $20m Series D
Heart valve designer and manufacturer Foldax announced today that it closed a Series D funding round with proceeds of $20 million. MemorialCare Innovation Fund led the round, which also included new investors Angel Physicians Fund and Sayah Bioventures. All existing investors, including BioStar Capital, Kairos Ventures and Caltech, participated as well. Salt Lake City-based Foldax […]
Medtronic wins CE mark for TAVI system in low-risk patients
Medtronic (NYSE:MDT) announced today that it received CE Mark approval for its Evolut transcatheter aortic valve implantation (TAVI) system. Evolut TAVI, now commercially launched in Europe, is now indicated for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The system’s indications in Europe now cover all risk categories for […]
Neovasc closes $11.5m offering
Neovasc (NSDQ:NVCN) annunced that it closed a previously announced registered direct offering worth approximately $11.5 million. The offering includes nearly 3.9 million units, consisting of one common share of the company and three-quarters of one warrant to purchase one common share. Each warrant entitles the holder to acquire one common share of the company at $2.88 […]
Medtronic lands CE Mark for Micra AV transcatheter pacing system
Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its Micra AV transcatheter pacing system (TPS). The Fridley, Minn.-based medtech giant touts its Micra AV as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The system is indicated for treating patients with AV block, adding to its CE Mark-approved leadless pacemaker portfolio. […]
FDA approves Abiomed’s Impella ECP clinical trial
Abiomed (NSDQ:ABMD) announced today that it received FDA investigational device exemption approval to begin a clinical trial for the Impella ECP heart pump. Impella ECP (expendable cardiac power) will be studied in the early feasibility, first-in-human trial for high-risk percutaneous coronary intervention (PCI) patients, according to a news release. The prospective, multi-center, non-randomized trial will assess […]
FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure
Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure. The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data […]
LivaNova touts results of sutureless aortic valve study
LivaNova (NSDQ:LIVN) said today that its Perceval sutureless implant is safe and effective compared to standard aortic valve replacement, according to a clinical study. The study, presented at the 100th annual meeting of the American Association of Thoracic Surgery (AATS), revealed that the Perceval sutureless surgical aortic valve demonstrated freedom from major adverse cerebral and cardiovascular […]
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