Neuro

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 […]

New Study Shows Triaging Stroke Patients Directly to Level 1 (Comprehensive) Stroke Centers Reduces Time to Treatment and Improves Patient Outcomes

Research bolsters current efforts to update triage and transport protocols around the country TORONTO, July 27, 2022 /PRNewswire/ — Implementing severity-based field triage leads to faster treatment and less disability for stroke patients. The research presented today at the Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting, and now published online in […]

Route 92 Medical’s Monopoint® Operating Platform Shows 82% First Pass Effect in Independent Study

SAN MATEO, Calif., July 25, 2022 (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a private medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the publication of an investigator-initiated, multicenter SLIC study of its proprietary Monopoint® operating platform showing 82% first pass efficacy. Results from 33 […]

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 […]

Acticor Biotech obtains “PRIME” status from the European Medicines Agency for glenzocimab in the treatment of stroke

Strengthening discussions with regulatory authorities to accelerate the clinical development of glenzocimab for its potential benefit in the treatment of stroke 87 patients already enrolled in Europe in the ACTISAVE Phase 2/3 registration study in stroke patients ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT), a clinical-stage biotechnology company developing innovative drugs […]

DiaMedica Therapeutics Announces Clinical Hold of its Phase 2/3 ReMEDy2 Clinical Trial for DM199

MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Company’s Phase 2/3 ReMEDy2 trial studying the use of the Company’s product […]

NeuroVasc Technologies Announces First Patient Treated in Clinical Trial to Evaluate Its Novel Stent-Retriever

IRVINE, Calif.–(BUSINESS WIRE)–NeuroVasc Technologies, Inc. today announced that the first patient has been treated in its US IDE Clinical Trial, ENVI RCT – NeuroVasc Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke. This trial will evaluate the safety and efficacy of the NeuroVasc ENVI™-SR, a stent-retriever intended for the […]

Rapid Medical Marks First Procedures with Numen™ Coil from MicroPort Scientific

Rapid Medical and MicroPort NeuroTech Join Forces to Pair Premium Numen™ Coil with the de Novo Comaneci™ Coil-Assist Device YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, a leading developer of advanced neurovascular devices, announces the expansion of its portfolio in the United States and the first Numen™ coil embolization procedure. Rapid Medical now has an […]

Health Canada Approves Penumbra’s RED Reperfusion Catheters

News from Penumbra Inc. June 23, 2022 ALAMEDA, Calif.–Penumbra Inc. (NYSE: PEN) shared that its latest RED Reperfusion Catheters received approval from Health Canada, expanding on the company’s extensive portfolio of innovative stroke products in Canada. The RED Catheters are designed with optimized trackability to help navigate the complex distal vessel anatomy […]