Other News

Surmodics Receives FDA Approval for the SurVeil™ Drug-Coated Balloon

Surmodics to receive $27 million milestone payment from Abbott EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the receipt of U.S. Food and Drug Administration (FDA) approval for the SurVeil™ drug-coated balloon (DCB). The […]

CorWave Announces Second Closing of Its Series C Funding at €61M to Finance Its First Industrial Deployment

CLICHY, France–(BUSINESS WIRE)–CorWave raised 61 million euros to fund its first industrial deployment and entry into clinical trials. SPI fund, managed by Bpifrance on behalf of the French Government as part of France 2030, and leading family controlled entrepreneurial groups were the main investors of this second closing. Founded in […]

Nuwellis Inc. Announces Pilot Agreement With DaVita Inc.

Supply Agreement to Pilot Ultrafiltration Therapy Services Offering in Select Markets MINNEAPOLIS, June 20, 2023 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced it has entered into a Supply and Collaboration Agreement with DaVita Inc. […]

RhythmScience Partners with MedAxiom

SAN FRANCISCO, June 20, 2023 /PRNewswire/ — RhythmScience, a leader in cardiac data management and services, announced their industry partnership with MedAxiom, the cardiovascular community’s premier source for organizational performance solutions. This significant collaboration signifies an important development for RhythmScience as they partner with MedAxiom to drive transformative changes in the cardiovascular […]

Cytokinetics Announces Start of MAPLE-HCM, a Phase 3 Clinical Trial of Aficamten Compared to Metoprolol in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

First Phase 3 Trial Evaluating Monotherapy with a Cardiac Myosin Inhibitor Compared to Monotherapy with a Beta Blocker in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., June 20, 2023 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a […]

U.S. FDA Approves First Anti-Inflammatory Drug for Cardiovascular Disease

LODOCO® (colchicine, 0.5 mg tablet) Reduces Cardiac Event Risk in Adult Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) by an Additional 31% on Top of Standard of Care. LODOCO Targets Residual Inflammation as an Underlying Cause of ASCVD and Can be Used Alone or in Combination with Cholesterol-Lowering Medications PARSIPPANY, N.J.–(BUSINESS WIRE)–AGEPHA Pharma […]

AccurKardia Announces Final Closing of $2.7 Million Series Seed Round

This investment will support AccurKardia’s mission to deliver world class clinical-grade ECG interpretation software to cardiac monitoring companies, thereby expanding access to the benefits of remote cardiac care to millions of patients worldwide. June 20, 2023 01:11 PM Eastern Daylight Time NEW YORK–(BUSINESS WIRE)–AccurKardia, Inc., a medical AI software company […]

HAYA Therapeutics Adds Douglas L. Mann, M.D. as Chairperson of Clinical Advisory Board

As a recognized cardiologist, clinical investigator, and cardiovascular researcher, Dr. Mann joins as company prepares to advance its lead heart failure candidate HTX-001 towards the clinic LAUSANNE, Switzerland & SAN DIEGO–(BUSINESS WIRE)–HAYA Therapeutics, SA, a company developing RNA-guided programmable precision medicines focused on long non-coding RNAs, today announced that Douglas […]

Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

LEHI, Utah–(BUSINESS WIRE)–Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant health data, having monitored more than 1 million babies, and […]

Mallinckrodt Announces Publication of Real-World Data on the Use of Extracorporeal Photopheresis (ECP) in Heart Transplant Patients

– Results from the largest European and first multicenter, retrospective, observational chart review study investigating the real-world use of ECP in heart transplant patients reinforce its use as a treatment for heart transplant rejection and prevention of rejection1 – DUBLIN, June 19, 2023 /PRNewswire/ — Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today […]