Attune Medical today announced positive data supporting the use of its ensoETM proactive esophageal cooling device. Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA investigational device exemption (IDE) for this indication just over one year ago. The […]
Cardiovascular
LivaNova president of cardiopulmonary is retiring
LivaNova announced today that Marco Dolci intends to retire from his position as president of the cardiopulmonary business unit. Dolci plans to retire by Dec. 31, 2023, continuing in his role to support the transition of responsibilities through the end of the year. The company appointed Franco Poletti to serve as interim GM of cardiopulmonary […]
MedTrace raises $19M for its PET-boosting technology
MedTrace Pharma announced today that it has raised €18.2 million (roughly $19 million) to fund the completion of its Phase 3 trial of its tech to make PET with oxygen-15 labeled water widely available. 15 O-water has a reputation as a gold-standard radioactive tracer for PET imaging, but supply chain problems around the substance have hindered […]
Boston Scientific completes enrollment in next-gen aortic valve registry
Boston Scientific (NYSE:BSX) announced today that its ACURATE Prime XL Nested Registry completed patient enrollment. The registry evaluates the Acurate Prime aortic valve system, the Marlborough, Massachusetts-based company’s next-generation technology. It enhances the Acurate neo2 transcatheter aortic valve replacement (TAVR) system, including a full-sized matrix. The system treats patients with severe symptomatic aortic stenosis across […]
FDA grants IDE to Orchestra BioMed for cardiac neuromod trial in pacemaker patients
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial. BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker. New […]
Biosense Webster begins Omnypulse pulsed-field ablation trial
Johnson & Johnson’s Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial. The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard ablation procedures. Dr. Dr. Mattias Duytschaever performed […]
Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech
Field Medical announced today that it closed an oversubscribed seed round with investments reaching $14 million. Private investors led the funding for the Cardiff-by-the-Sea, California-based cardiac ablation technology developer. Multiple strategic investors also joined the round. The company earmarked the funds to support preclinical-to-clinical development activities. That includes first-in-human studies slated to begin in early […]
Inspira submits cardio-pulmonary bypass device for FDA clearance
Inspira Technologies (Nasdaq:IINN) announced that it submitted its Inspira ART100 cardio-pulmonary bypass device for FDA clearance. Ra’anana, Israel-based Inspira designed the system to transform external breathing, empowering breathing without lungs. The company anticipates potential clearance for the system in the first half of 2024. ART100’s bid for 510(k) clearance is backed by a comprehensive usability […]
TAVR tech developer JenaValve adds J&J vet to its board
JenaValve Technology announced that it appointed cardiovascular industry veteran Shlomi Nachman to its board of directors. Nachman brings more than 25 years of experience to the transcatheter aortic valve replacement (TAVR) system maker’s board. He previously held senior operating roles at Johnson & Johnson. That included serving as company group chair of cardiovascular and specialty […]
FDA clears 14-day ECG patch, cloud platform from SmartCardia
SmartCardia announced today that it received FDA clearance for its seven-lead, real-time ECG monitoring patch and cloud platform. The regulatory nod marks the second this week for wearable ECG technology. Samsung spinoff Wellysis picked up FDA clearance for its own ECG patch on Sept. 13. Lausanne, Switzerland-based SmartCardia designed its easy-to-wear, cable-free, waterproof patch for […]
FDA authorizes Attune Medical’s ensoETM for use in RF ablation procedures
Attune Medical announced today that it received FDA de novo marketing authorization for its ensoETM device in ablation procedures. Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA investigational device exemption (IDE) for this indication just over […]
