JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic Regurgitation Indication IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced […]
Author: Ken Dropiewski
FAST BioMedical Announces Successful Completion of Multi-center Acute Congestive Heart Failure Trial in Germany
INDIANAPOLIS and BERLIN and BAD NAUHEIM, Germany, Jan. 9, 2020 /PRNewswire/ — FAST BioMedical announced the completion of the EMPAKT-CHF clinical trial at Charité – Universitätsmedizin Berlin and Kerckhoff Klinik in Bad Nauheim. The trial evaluated the impact of FAST BioMedical’s Blood Volume and Kidney Function measurement technology in patients with acute congestive heart failure and cardiorenal syndrome. This […]
Alucent Biomedical Announces FDA Approval to Proceed with Natural Vascular Scaffolding Clinical Trial
SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. has received U.S. Food and Drug Administration approval to proceed with a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral artery disease (PAD) of the lower extremities, a […]
Penumbra Announces FDA Clearance of Indigo® Aspiration System for Treatment of Pulmonary Embolism
ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the Indigo® Aspiration System. As part of the Indigo Aspiration System, the Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, […]
MicroVention Announces FDA Premarket Approval of a New Flow Diverter for the Treatment of Brain Aneurysms
Aliso Viejo, CA. – January 9, 2020 –MicroVention, Inc., a U.S. based subsidiary of Terumo and a global neurovascular company announced the FDA Premarket Approval (PMA) for the FRED® (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms. The FRED® device is the first flow diverter in the U.S. to use […]
FDA Confirms Non-Exempt Status of Medical Device but No Plans to Inform the Patients as Confirmed by Dr. Rajamannan in Press Conference at Most Sacred Heart of Jesus Cardiology and Valvular Institute
FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens. SHEBOYGAN, Wis., Jan. 9, 2020 /PRNewswire/ — Following recent reporting by Kaiser Health News that the FDA has lifted their exemption laws, Dr. Nalini Rajamannan a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, […]
HeartBeam Appoints Rich Ferrari and Marga Ortigas-Wedekind to its Board of Directors
Industry Veterans Join Diagnostic mHealth Company SANTA CLARA, Calif., Jan. 7, 2020 /PRNewswire/ — HeartBeam, Inc., a cardiac diagnostic mHealth company, today announced it has expanded its Board of Directors adding two seasoned professionals, Rich Ferrari, a Silicon Valley venture capitalist and Marga Ortigas-Wedekind, a marketing executive in the cardiac monitoring space. Rich Ferrari co-founded De […]
Microbot Medical Receives Intention to Grant from European Patent Office for a Patent Application Covering its Self-Cleaning Shunt
HINGHAM, Mass., Jan. 08, 2020 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) has received an official communication from the European Patent Office (EPO) regarding its intention to grant European Patent Application No. 11795301, covering the Company’s Self-Cleaning Shunt (SCS™). Globally, the Company now has 36 patents issued/allowed and 16 […]
CHF Solutions Announces Presentation of Clinical Data with Aquadex FlexFlow® Highlighting Efficacy and Simplicity of Use In Treating Critical Care Patients
EDEN PRAIRIE, Minn., Jan. 08, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced results from an investigator-initiated retrospective analysis of utilization of the Aquadex FlexFlow aquapheresis system at Lenox Hill Hospital in New York City. The study was presented at the American Society of Nephrology’s Kidney Week in […]
BioCardia Announces New U.S. Patent Covering CardiAMP Cell Therapy and Issuance of Two Asian Patents Covering Radial Artery Approach for Cardiac Cell and Gene Therapy Delivery
SAN CARLOS, Calif., Jan. 08, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of three new patents for the company’s technologies in the U.S., China and Japan. The new U.S. patent relates to the cell potency […]
