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, […]
Author: Ken Dropiewski
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 […]
Proximo Medical Named Commercialization Partner for CeloNova BioSciences, Inc. in Select U.S. Markets
CeloNova BioSciences’ COBRA PzF NCS is world’s first and only non drug-eluting, nanocoated coronary stent; specifically designed to treat PCI patients at high risk for bleeding complications CASTLE PINES, Colo., Jan. 8, 2020 /PRNewswire/ — Today Proximo Medical, LLC, a fractional commercial organization for start-up medical device technologies and established medical device companies […]
FDA Approves Less Invasive Surgical Approach for Abbott’s Heart Pump to Help Patients Avoid Open Heart Surgery
– For people battling advanced heart failure, Abbott’s HeartMate 3 heart pump can now be implanted through an incision in the chest wall versus open heart surgery – New, less invasive technique provides cardiac surgeons with the ability to choose the optimal surgical method for their patients ABBOTT PARK, Ill., Jan. […]
Ra Medical Systems Names Dr. Chris Folk Vice President of Engineering
CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focusing on commercializing excimer laser systems to treat vascular and dermatological diseases, announces the appointment of Chris Folk, PhD, as Vice President of Engineering, effective January 13, 2020. With more than 20 years of engineering experience primarily in […]
Zynex Expands Corporate Headquarters to Accommodate Growth
ENGLEWOOD, Colo., Jan. 7, 2020 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, announced today that it has signed an addendum to its corporate headquarters building lease expanding the footprint to 86,000 square […]
Amarin Provides Update to Preliminary 2019 Results and Further Details on 2020 Outlook
Unaudited Full-Year 2019 Net Total Revenue Estimated At or Slightly Above Upper-End of Prior Guidance of $410 to $425 Million U.S. Sales Force Expansion On-Track for Doubling to 800 Sales Professionals in Early 2020 Full-Year 2020 Net Total Revenue Guidance Reiterated at $650 to $700 Million, Predominately from U.S. Sales […]