SAN CARLOS, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA) (BioCardia or the “Company”) today announced it has entered into definitive agreements with investors for the purchase and sale of 2,038,836 shares of its common stock at a purchase price of $5.15 per share in a registered direct […]
Author: Ken Dropiewski
Centerline Biomedical Kicks Off First Clinical Study of Intra-Operative Positioning System Technology
First surgical case launches multicenter prospective clinical study of FDA-cleared product to support international market entry CLEVELAND, Dec. 15, 2020 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform. The FDA-cleared […]
Corvion Receives Breakthrough Device Designation from FDA
WEBSTER, Texas, Dec. 16, 2020 /PRNewswire/ — Corvion – developer of fully implanted mechanical circulatory support devices – announced today that it has received Breakthrough Device Designation for its fully implanted Left Ventricular Assist Device (LVAD) from the FDA. The designation will allow the company to interact with the FDA’s experts to […]
Okami Medical Announces FDA 510(k) Clearance of the LOBO-5 Vascular Occluder
ALISO VIEJO, Calif., Dec. 16, 2020 /PRNewswire/ — Okami Medical Inc., a medical device company, today announced the expansion of its LOBO™ Vascular Occlusion System product line with the U.S. FDA 510(k) clearance of the LOBO-5 Vascular Occluder. The LOBO (LOw-profile Braided Occluder) system is uniquely designed to provide interventional physicians with a single-device, […]
Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of […]
Covanos Announces Appointment of Iconic Industry Leader Gil Amelio, Ph.D. to Board of Directors
ATLANTA, Dec. 16, 2020 /PRNewswire/ — Covanos, Inc., a privately-held medical technology company that is developing C-HEART, a PC-based software product that uses proprietary advances in computational fluid dynamics to rapidly and non-invasively diagnose the severity of coronary artery blockages, today announced the appointment of Gil Amelio, Ph.D. to the Covanos Board of Directors. “We are […]
Advanced Bifurcation Systems Announces First Closing Of Series A Financing
LIVERMORE, Calif., Dec. 16, 2020 /PRNewswire/ — Advanced Bifurcation Systems, Inc. (ABS), a Livermore, CA-based maker of the ABS System, a proprietary stent delivery system that is specifically designed to efficiently treat coronary bifurcation lesions, is pleased to announce the first closing of an $11 million Series A equity financing. The round was led by […]
FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor
LAKE OSWEGO, Ore., Dec. 16, 2020 /PRNewswire/ — BIOTRONIK today announced FDA clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new BIOMONITOR IIIm injectable cardiac monitor (ICM), as shown in a published case report1. Physicians will now have access to daily reports on […]
Ontrak Announces Follow-On Offering of Non-Convertible Perpetual Preferred Stock
Company to use non-dilutive capital for working capital, M&A, investment in technology SANTA MONICA, Calif.–(BUSINESS WIRE)–Ontrak, Inc. (NASDAQ: OTRK, OTRKP) (“Ontrak” or the “Company”), a leading AI-powered and telehealth enabled, virtualized healthcare company, today announced that it has commenced an underwritten public offering of shares of its Series A Cumulative Perpetual Preferred Stock […]
Two Milestones Achieved Toward Small Bore Access with Impella
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted […]
Recent
Popular
- No commented posts yet