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 and Drug Administration (FDA) has approved an investigational device exemption […]

Bodyport Receives FDA Clearance for the Bodyport Cardiac Scale™

The Bodyport Cardiac Scale is available to monitor heart function and fluid status in a single step at home SAN FRANCISCO–(BUSINESS WIRE)–Bodyport, a digital therapeutics company on a mission to address complex chronic conditions, announced today that its noninvasive biomarker platform, the Bodyport Cardiac Scale™ received U.S. Food & Drug […]

INSERTING and REPLACING Viz.ai Receives FDA 510(k) Clearance for Viz SDH

AI-powered Viz SDH automatically detects subdural hemorrhage, enables effective triage and optimal care SAN FRANCISCO–(BUSINESS WIRE)–Insert after fourth paragraph of release: footnote 2. The updated release reads: VIZ.AI RECEIVES FDA 510(K) CLEARANCE FOR VIZ SDH AI-powered Viz SDH automatically detects subdural hemorrhage, enables effective triage and optimal care Viz.ai, the […]

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 in Toronto. TIGERTRIEVER 13 is the smallest revascularization device in […]

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 wireless data collection, which is uploaded to a secure cloud […]

Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure

NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program Evaluating Sotagliflozin in Almost 12,000 People THE WOODLANDS, Texas, July 27, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and filed its New Drug Application (NDA) 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 endovascular treatments. The company also announced the full U.S. commercial […]

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. The approval expands the number of patients eligible for treatment […]

IRHYTHM GAINS FDA CLEARANCE FOR ITS CLINICALLY INTEGRATED ZEUS SYSTEM

Developed in partnership with Verily, the Zio® Watch and the ZEUS System combine to create a clinical grade watch to detect and characterize AFib and integrate with clinician’s workflow SAN FRANCISCO, July 22, 2022 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, […]

RapidAI Receives FDA Clearance for Rapid Hyperdensity

The new solution allows for quick identification of hyperdense volumes to improve hemorrhage management SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, the newest addition to the RapidAI platform. The tool empowers […]