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 […]
Author: Ken Dropiewski
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 […]
Johnson & Johnson Completes Acquisition of Abiomed
Broadens MedTech Portfolio with World Leading Solutions for Heart Recovery Strengthens Position in High-Growth MedTech Segments NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson (NYSE: JNJ), the world’s largest, most diversified healthcare products company, today announced it has completed its acquisition of Abiomed, Inc. Abiomed is now part of Johnson & Johnson […]
Acutus Medical Achieves EU MDR Submission Milestone in Sale of Left-Heart Access Portfolio to Medtronic
CARLSBAD, Calif., Dec. 21, 2022 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced that the Company has achieved the second milestone under the asset purchase agreement with Medtronic of […]
FDA Approves Impella ECP Pivotal Heart Pump and First Patients Enrolled in Pivotal Clinical Trial
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (Nasdaq: ABMD) announces the United States Food and Drug Administration (FDA) has approved the version of Impella ECP that will be used in the Impella ECP Pivotal Trial, and the first two patients have been enrolled in the trial. Amir Kaki, MD, director of mechanical circulatory support at […]
CytoSorbents Receives Recommendation from Independent Data and Safety Monitoring Board to Continue Pivotal STAR-T Trial As Planned Without Modifications
PRINCETON, N.J., Dec. 21, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that it has received the recommendation from the independent Data and Safety Monitoring Board (DSMB) to continue the […]
Aerami Therapeutics Announces Completion of Dosing in Phase 1 Trial of AER-901 (inhaled imatinib), a Critical Milestone Toward the Planned Initiation of a Phase 2 Trial in Pulmonary Arterial Hypertension (PAH) During the First Half of 2023
AER-901 (inhaled imatinib), a potential reverse-remodeling therapy, is being developed to address unmet need for PAH treatments that target pulmonary vascular remodeling while supporting ease-of-use for patients. PAH is a rare and progressive disease with no cure; pulmonary vascular remodeling is believed to drive disease progression and poor outcomes, however, […]



