Author: Ken Dropiewski

Svelte Medical Systems Receives FDA Approval For SLENDER IDS® And DIRECT RX® Bioresorbable Coated Drug-Eluting Stent Systems

World’s Lowest Profile Drug-Eluting Stent Systems with the Lowest Rate of 1 Year Reintervention Reported in a U.S. Pivotal Study Now Approved for Use in U.S. Patients NEW PROVIDENCE, N.J.–(BUSINESS WIRE)–Svelte Medical Systems received U.S. Food and Drug Administration (FDA) approval to commercialize the SLENDER IDS® fixed-wire and DIRECT RX® rapid-exchange drug-eluting […]

HeartFlow Files for FDA Clearance of Next Generation Product Offering to Help Evaluate the Presence of Narrowings and Plaque in the Coronary Arteries

Advanced innovations leverage HeartFlow’s core AI technology and are critical additions to HeartFlow’s product portfolio for delivering complete cardiac care REDWOOD CITY, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced it has submitted a 510k premarket application to the U.S. Food […]

MindMics Announces Successful Clinical Studies with Scripps Health

The new cardiac function studies demonstrate precise medical results with the technology in the form of a consumer wearable BOSTON–(BUSINESS WIRE)–MindMics, the actionable health monitoring company, today, announced the results of two ground-breaking studies reported by Scripps Health at the American Heart Association. Both results demonstrate the effectiveness of MindMics’ technology – Infrasonic […]

Philips to further expand its image-guided therapy devices portfolio through acquisition of Vesper Medical

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG; AEX: PHIA), a global leader in health technology, today announced that it has signed an agreement to acquire Vesper Medical Inc., a US-based medical technology company that develops minimally-invasive peripheral vascular devices. Vesper Medical will further expand Philips’ portfolio of diagnostic and therapeutic devices […]

Dr. Blaise W. Baxter Joins Artio Medical’s Leadership Team

Presents update on novel neurovascular medical device at B.R.A.I.N. Conference PRAIRIE VILLAGE, Kan., Dec. 14, 2021 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, today announced that distinguished neurovascular and peripheral vascular interventional radiologist, Blaise W. Baxter, MD, FRCPC, FSNIC, has […]

InterVene’s BlueLeaf Endovenous Valve Formation (EVF) System Granted Breakthrough Device Designation by the FDA

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–InterVene Inc. announced today that it has received Breakthrough Device Designation by the FDA for the company’s BlueLeaf® Endovenous Valve Formation System. BlueLeaf is the first catheter-based solution developed for deep vein reflux — the failure of venous valves in the legs — which does not require […]

AtaCor Medical Completes Enrollment in its Initial Acute Extravascular Implantable Cardioverter Defibrillator (EV-ICD) Study

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–AtaCor Medical, Inc. announced today that it has completed enrollment in its initial acute Extravascular Implantable Cardioverter Defibrillator (EV-ICD) study. Named the PASS-PULL EV-ICD Study, it is designed for acute evaluation of AtaCor’s EV-ICD lead in connection with commercially-available ICDs. Currently, when patients require ICD therapy, wires or […]

Hyperfine Appoints New Board of Directors

GUILFORD, Conn., Dec. 13, 2021 /PRNewswire/ — Hyperfine Inc., creator of Swoop®, the first FDA-cleared portable magnetic resonance imaging™ (MRI) device, today announced the Board of Directors that will serve subsequent to the closing of the previously announced business combination between Hyperfine, Liminal Sciences, Inc., and HealthCor Catalio Acquisition Corp, subject to […]

Medtronic announces cash dividend for third quarter of fiscal year 2022

DUBLIN, Dec. 10, 2021 /PRNewswire/ — The board of directors of Medtronic plc (NYSE:MDT) on Thursday, December 9, 2021, approved the fiscal year 2022 third quarter cash dividend of $0.63 per ordinary share, representing a 9 percent increase over the prior year. This quarterly declaration is consistent with the dividend announcement made by the company in May […]

Angion and Vifor Pharma Report Topline Results from Phase 2 GUARD Trial of ANG-3777 in Cardiac Surgery-Associated Acute Kidney Injury

— Angion to host a conference call today at 4:30 p.m. EST UNIONDALE, N.Y. and ST. GALLEN, Switzerland, Dec. 09, 2021 (GLOBE NEWSWIRE) — Angion Biomedica Corp. (NASDAQ:ANGN) and Vifor Pharma today announced results from the exploratory Phase 2 GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving […]