DENVER–(BUSINESS WIRE)–Cleerly, the company creating a new standard of care to aid in the diagnosis of heart disease, announced that its recently U.S. Food and Drug Administration (FDA)-cleared Cleerly ISCHEMIA software device applied to a non-invasive coronary CT angiogram (CCTA) can be billed using the new Category I CPT® code 75580. The American […]
Other News
Teleflex Reports Fourth Quarter and Full Year 2023 Financial Results
WAYNE, Pa., Feb. 22, 2024 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX) (the “Company”) today announced financial results for the fourth quarter ended December 31, 2023. Fourth quarter financial summary Revenues of $773.9 million, reflective of five fewer shipping days year-over-year, up 2.1% compared to the prior year period; up 0.7% on […]
PrepMD Partners with MediaSphere and Esteemed Cardiac Experts for Groundbreaking Virtual Device Clinic Leadership Summit
BRAINTREE, Mass., Feb. 21, 2024 /PRNewswire/ — PrepMD, as the exclusive sponsor, is thrilled to announce its partnership with MediaSphere and distinguished cardiac professionals, including Beth Davenport and Sallie Gustafson, to present the largest-ever virtual accredited Cardiac Device…
Saghmos Therapeutics Announces Appointment of FDA Veteran Stephen Grant, MD, as Chief Regulatory Officer
GREENWICH, Conn.–(BUSINESS WIRE)–Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced the appointment of Stephen Grant, MD, as Chief Regulatory Officer. Dr. Grant was the former Deputy Director, Division of Cardiology and Nephrology at the FDA. During his more than 20-year career at the FDA, he was responsible for […]
Route 92 Medical Announces Completion of Enrollment in the SUMMIT MAX Clinical Trial
SAN MATEO, Calif., Feb. 21, 2024 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the completion of enrollment in its 250-patient SUMMIT MAX clinical trial (NCT05018650) evaluating the safety and effectiveness of its HiPoint™ 88 […]
FineHeart Widens International IP Protection for FlowMaker®
BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A., a clinical stage medical device company developing innovative devices for cardiology today announced the successful filing of six new international patents for its FlowMaker®, a fully implantable device for the treatment of patients with advanced heart failure. These patents increase the company’s solid international portfolio to 147 […]
X-trodes Receives FDA 510(k) Clearance for Wearable “Skin” Solution that Brings Medical-Grade Electrophysiological Monitoring to the Home
HERZLIYA, Israel, Feb. 20, 2024 /PRNewswire/ — X-trodes, a bio-convergence company bringing wireless monitoring solutions to the home environment, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for X-trodes’ Smart Skin solution (marketed as X-trodes System M), a new wireless wearable technology for advanced electrophysiological monitoring. X-trodes’ Smart Skin is comprised of customizable dry-printed […]
BiVACOR® Receives $13 Million to Support Clinical Trials for the Company’s Total Artificial Heart
GOLD COAST, Australia & HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–BiVACOR®, a clinical-stage medical device company, today announced $13 million (USD) awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support BiVACOR’s Total Artificial Heart program and future product enhancements. Led by Monash […]
Cagent Vascular Raises $30 Million Series C Financing
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, Inc., a rapidly growing commercial stage medical device company, today announced a Series C Financing close in excess of $30M. U.S. Venture Partners (USVP), led the round. Participation included new investor Blue Ridge Medical, LLC and existing investors, including Sectoral Asset Management. “We are pleased with […]
Bayer initiates Phase II study with first-in-class anti-alpha2 antiplasmin antibody in patients with deep vein thrombosis
BERLIN–(BUSINESS WIRE)–Bayer announced today the start of a Phase II clinical trial (SIRIUS study) with BAY3018250, an investigational first-in-class anti-alpha2 antiplasmin (anti-α2ap) antibody in patients with deep vein thrombosis (DVT). The results of this study might provide evidence of anti-α2ap antibody’s potential as a treatment option in indications of high […]



