This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure. The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology. In this week’s DeviceTalks Weekly podcast, […]
OneProjects raises $12m for development of its cardiac imaging system
OneProjects — an Irish-German cardiac imaging startup — announced today that it has raised $12 million (€11 million) in a Series A round. LSP, based in the Netherlands, investing from its LSP Health Economics Fund 2, and the Atlantic Bridge University Fund (Ireland), led the round, with participation from Enterprise Ireland and a selection of […]
inHeart raises $4.2m
Cloud-based medical image analysis tech developer inHeart announced today that it closed a funding round worth $4.2 million (€3.7 million). Pessac, France-based inHeart, which provides image analysis for cardiac interventions on patients with arrhythmias, said in a news release that the funding round, led by Elaia, will be used to accelerate commercial development in Europe, […]
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 […]
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 […]
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