Cordis announced today that it supports a new expanded coverage decision from the Centers for Medicare & Medicaid Services (CMS). The expanded CMS coverage widens access to minimally invasive endovascular carotid therapy for patients with carotid artery disease. Cordis develops the Precise Pro Rx carotid stent system for this therapy. In a news release, the […]
Vascular
FDA clears next-gen image-guided therapy tech from GE HealthCare
GE HealthCare announced today that the FDA granted 510(k) clearance to its Allia IGS Pulse system. The latest addition to GE HealthCare’s image-guided system (IGS) offerings features a new imaging chain. GE HealthCare says it engineered this feature to provide exceptional imaging at the right dose. This enables visible impact in complex cardiology interventions regardless […]
MedTech Innovator announces 2023 Grand Prize winner
MedTech Innovator, a global medtech accelerator, today announced that StrokeDx won the grand prize in its 2023 Global Competition. StrokeDx develops a rapid, portable and affordable stroke diagnostic device. The Pasadena, California-based company won a live audience vote at AdvaMed’s The MedTech Conference on Oct. 10. It beat out four other finalists within the 2023 […]
WhiteSwell fluid removal system produces positive study results
WhiteSwell announced positive initial results from its DELTA-HF trial evaluating its eLym system for excess fluid removal. Galway, Ireland-based WhiteSwell designed eLym to treat acute decompensated heart failure (ADHF). It presented data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio. The study evaluates the eLym minimally invasive catheter-based […]
LivaNova adds former NuVasive CEO to its board
LivaNova announced today that it appointed J. Christopher Barry as a new board director. Barry’s appointment becomes effective today and he joins the board’s Audit and Compliance Committee. In turn, Andrea Saia intends to retire from the board on Dec. 31, 2023. Saia initially joined the board of the London-based medtech company as a director […]
Shifamed’s Akura Medical raises $35M for thrombectomy system
Akura Medical, a Shifamed portfolio company, today announced the closing of a $35 million Series B financing round. Los Gatos, California-based Akura develops a differentiated approach to address the challenges of venous thromboembolism (VTE). The company earmarked the funds for supporting its FDA 510(k) clearance submission for the Akura mechanical thrombectomy platform. Other uses include […]
Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B
MedAlliance announced today that Cordis acquired it for a total consideration that could reach up to $1.135 billion. The companies initially announced the planned deal in October of last year. Cordis, which develops interventional cardiovascular and endovascular technologies, made a $35 million investment last year. Its upfront closing payment totals $200 million, with achievement milestones […]
PercAssist treats first patient in heart failure support trial
PercAssist announced today that it successfully completed the first patient treatment in its EUREKA first-in-human clinical study. The study evaluates PercAssist’s minimally invasive extravascular platform that provides hemodynamic support for chronic heart failure patients. Principal investigator Dr. Petr Neuzil completed the first case at the Na Homolce Hospital in Prague, Czech Republic. Also involved were […]
FDA grants IDE to EnCompass for cerebral embolic protection system in TAVR procedures
EnCompass Technologies announced today that it received FDA investigational device exemption for its F2 cerebral embolic protection system. The conditional IDE enables a study of the F2 system for protecting patients from brain injury during cardiovascular procedures. According to a news release, all cardiovascular procedures cause the release of particulate debris and air bubbles — […]
Inspira to unveil new line of cardio-pulmonary bypass devices
Inspira Technologies (Nasdaq:IINN) announced today that it plans to unveil its new Inspira ART line of medical devices. Ra’anana, Israel-based Inspira plans to debut the devices at the Extracorporeal Life Support Organization (ELSO) Conference in Seattle. The line of devices includes the ART100 cardio-pulmonary bypass (CPB) device for patients undergoing CPB procedures. Additionally, the company has […]
Boston Scientific wins FDA nod for intravascular ultrasound system
Boston Scientific announced today that the FDA cleared its Avvigo+ multi-modality guidance system. The next-generation system provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include percutaneous coronary intervention (PCI) procedures. Boston Scientific’s PCI business continues to […]