Regulatory

CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System

US Based Pilot Study to enroll patients who develop communicating hydrocephalus following subarachnoid hemorrhage BOSTON, Aug. 9, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food […]

Rapid Medical Gains FDA Clearance for the Smallest & Only Adjustable Thrombectomy Device

TIGERTRIEVER™13 is designed to reduce vessel tension during ischemic stroke treatment YOKNEAM, Israel & TORONTO–(BUSINESS WIRE)–Rapid Medical, a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting […]

CardiAi Inc. launches “BPAro” a Brand New FDA & Health Canada approved Clinically validated 24-hour Ambulatory Blood Pressure Monitoring System with all new features including Bluetooth, Diabetes setting & Auto Interpretation of results

CALGARY, AB, July 27, 2022 /PRNewswire/ – CardiAI Inc. is pleased to announce the Global launch & distribution of their brand new 24-hour Ambulatory Blood Pressure monitoring system. BPAro is a compact, portable, German-manufactured, self-monitoring blood pressure device that uses Bluetooth for […]

First and Only Peripheral Tri-axial 4-French Low-Profile Self-Expanding Stent System Receives FDA Approval

BIOTRONIK Launches its Pulsar-18 T3 Self-Expanding Stent System in the U.S. LAKE OSWEGO, Ore., July 26, 2022 /PRNewswire/ — BIOTRONIK, LAKE OSWEGO, USA, announced that it received U.S. Food and Drug Administration (FDA) approval of its innovative Pulsar®-18 T3 peripheral self-expanding stent system for an improved implantation procedure for […]

Neovasc Announces FDA Approval of Planned COSIRA II Sub-studies and Single Arm Registry to Allow Inclusion of Additional Specified Patient Populations

VANCOUVER and MINNEAPOLIS, July 26, 2022 (GLOBE NEWSWIRE) — via NewMediaWire – Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced the United States Food and Drug Administration (“FDA”) has approved a protocol supplement to the COSIRA-II Investigational Device Exemption (“IDE”) Trial. […]