SUNNYVALE, Calif., May 02, 2022 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that that the U.S. Food and Drug Administration (FDA) approved expanded […]
Regulatory
Boston Scientific Receives FDA Clearance for the EMBOLD™ Fibered Detachable Coil
MARLBOROUGH, Mass., April 28, 2022 – Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the EMBOLD™ Fibered Detachable Coil, which is indicated to obstruct or reduce the rate of blood flow in the peripheral […]
U.S. Food and Drug Administration Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms
Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the source of obstructive HCM Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) […]
FDA Clears Caretaker Medical’s Wireless Monitor for NonInvasive & Continuous Cardiac Output, Stroke Volume, and Advanced Hemodynamics
VitalStream™, Featuring Patented Pulse Decomposition Analysis™ technology becomes the World’s First Wireless Wearable Monitor for Continuous Blood Pressure and Advanced Hemodynamics – All with a single, easy-to-apply Finger Sensor Caretaker Medical, a digital health leader in continuous “beat by beat” […]
TransMedics Receives FDA PMA Approval of OCS™ DCD Heart Indication
ANDOVER, Mass., April 28, 2022 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has […]
BIOTRONIK Announces FDA Approval of Renamic Neo with LiveSupport Software
LAKE OSWEGO, Ore., April 26, 2022 /PRNewswire/ — BIOTRONIK, Inc. announced today it has received U.S. Food and Drug Administration (FDA) approval of Renamic Neo, the company’s state-of-the-art programmer for implanted cardiac rhythm management devices such as ICDs, pacemakers, and implantable cardiac […]
FDA Clearance Granted for New Dual Lumen Catheter That Enables Precise Visualization and Treatment Access to the Left Heart
SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Franklin Mountain Medical announced today that the company has received FDA clearance of its patented UltraNav Transseptal Catheter System for controlled access and delivery of cardiovascular catheters and guidewires to the heart chambers via transseptal puncture. The success […]
BENDIT Technologies Receives U.S. Food and Drug Administration 510(k) Clearance of its Bendit 021″ steerable microcatheter
TEL AVIV, Israel, April 18, 2022 /PRNewswire/ — BENDIT Technologies, a company focused on the development of a steerable microcatheter platform, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bendit21 microcatheter for treatment in the […]
FDA Clears Four New Coronary Micro Support Catheters
Non-tapered metal-alloy support catheter platform receives FDA clearance for use in coronary and peripheral vasculature. Transit Scientific now has one of the largest platforms of FDA cleared microcatheters in the industry. PARK CITY, Utah, April 12, 2022 /PRNewswire/ — Transit Scientific announced […]
TRUVIC Announces 510(k) Clearance for the Prodigy™ Thrombectomy System
First regulatory milestone as part of a strategy to advance patient care CAMPBELL, Calif.–(BUSINESS WIRE)–Truvic Medical, Inc., a wholly owned subsidiary of Imperative Care, Inc., today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for […]