Author: Ken Dropiewski

Acutus Medical Announces Acceptance of the AcQForce Flutter Abstract for Presentation during the Late-Breaking Clinical Trials and First Report Investigations sessions at the 2023 AF Symposium

CARLSBAD, Calif., Dec. 29, 2022 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the acceptance of the AcQForce Flutter abstract titled “AcQForce Flutter Trial Clinical Results: Force Sensing RF Ablation with Low […]

Inspira™ Technologies Signs Strategic OEM Agreement with Terumo Cardiovascular

Terumo Cardiovascular is a division of Terumo Corporation, a leading medical device company operating in 160+ countries and regions RA’ANANA, Israel, Dec. 27, 2022 /PRNewswire/ — Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the “Company” or “Inspira Technologies”), a groundbreaking respiratory support technology company, announced today that it has signed an exclusive OEM (Original Equipment Manufacturing) agreement […]

Koya Medical Announces the Addition of Chief Medical Officer Dr. Thomas Maldonado to Their Executive Leadership Team

Dr. Maldonado joins Koya as Chief Medical Officer and member of the Medical Advisory Board OAKLAND, Calif., Dec. 27, 2022 /PRNewswire/ — Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, today announced the addition of Dr. Thomas Maldonado as Chief […]

TAVI or TAVR is a Boon for Patients with Critical Heart Valve-Related Conditions – Opine Experts at Manipal Hospital Sarjapur

BENGALURU, India, Dec. 26, 2022 /PRNewswire/ — In the field of Cardiac science, a relatively new but safe and successful non-surgical technique (TAVI/TAVR) is advocated, giving new hope for life to patients with specific heart-valve-related conditions. Patients who have Aortic Stenosis, meaning narrowed aortic valves can be benefitted from this procedure. The aortic valve […]

Owlet Announces FDA Software-as-a-Medical Device Submission for Heart Rate and Oxygen Displays and Notifications

Owlet submitted a de novo classification request to the FDA for an over-the-counter software-as-a-medical-device that offers heart rate and oxygen displays and notifications in conjunction with Owlet’s existing Dream Sock sleep monitoring capabilities. December 22, 2022 04:05 PM Eastern Standard Time LEHI, Utah–(BUSINESS WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. […]

ITC Rules Apple Violated AliveCor’s Patents

Limited Exclusion Order would bar Apple from importing infringing Apple Watches MOUNTAIN VIEW, Calif., Dec. 22, 2022 /PRNewswire/ — AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, today announced that the International Trade Commission (ITC) has issued its Final Determination ruling that Apple Watch infringed AliveCor’s patented technology. The ITC issued a Limited […]

Acticor Biotech Provides an Update on the Us Regulatory Discussion with the FDA

PARIS–(BUSINESS WIRE)–Regulatory News: Acticor Biotech, (ISIN: FR0014005OJ5 – ALACT) (Paris:ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, is discussing with FDA to set up a Type C meeting for early 2023 with the same objective as for the recent meeting with the […]

CARMAT Announces the Appointment of Alexandre Conroy as Chairman of the Board of Directors

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced the co-option of Alexandre Conroy to the Company’s Board of Directors in place of Jean-Pierre Garnier, […]

New ISHLT Guidelines Support Use of CareDx’s HeartCare Solutions, AlloMap and AlloSure, in Routine Monitoring of Heart Transplant Patients

ISHLT Guidelines Recommend Earlier Use of AlloMap Heart Starting 2 Months Post-Transplant Based on Strength of Clinical Studies ISHLT Guidelines Recommend Remote Use of GEP and dd-cfDNA Heart Transplant Surveillance, as in HeartCare, May be Used to Reduce the Need for Biopsies and Hospital Visits BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: […]

BioCardia Letter to Shareholders

SUNNYVALE, Calif., Dec. 22, 2022 (GLOBE NEWSWIRE) — BioCardia, Inc. (Nasdaq: BCDA), a clinical-stage developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases issued the following letter to shareholders: Dear Shareholders, BioCardia is now advancing four novel cell therapies, with three focused on heart disease, a leading […]