NeuroVasc Announces First Patient Enrolled in ENVI™-SR Mechanical Thrombectomy System Clinical Trial in China

Pivotal trial will assess use of the device for blood clot removal in strokes IRVINE, Calif.–(BUSINESS WIRE)–NeuroVasc Technologies, Inc. today announced that the first patient has been treated in a Chinese Pivotal Randomized Controlled Trial to evaluate the safety and efficacy of the ENVI™-SR Mechanical Thrombectomy System (ENVI™-SR), a stent-retriever for […]

MCRA Expands Neurology Division into Neurointerventional Market

– Robert Herrmann, Ph.D, Former U.S. Food & Drug Administration (FDA) Team Lead and Lead Reviewer for Neurointerventional and Neurosurgical Devices joins MCRA as Director, Neurointerventional Regulatory Affairs. WASHINGTON, Sept. 22, 2021 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating U.S. and International […]

Rhaeos, Inc. Awarded $4 Million NIH SBIR Grant to Expand Quantitative Measurement Capabilities of its FlowSense™ Noninvasive Wireless Sensor

EVANSTON, Ill., Sept. 16, 2021 /PRNewswire/ — Rhaeos, Inc., a private medical device company focused on the care of patients with hydrocephalus, announced today it was awarded a $4 million, multi-year grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program through the National Institute of Neurological Disorders and Stroke […]

Sensome Begins Human Trial for Its AI-Powered Stroke Guidewire

PARIS–(BUSINESS WIRE)–Sensome, the company pioneering the connected medical device revolution with the world’s smallest biological tissue sensor, announced today that Gold Coast University Hospital (GCUH) in Australia enrolled the first patients in the Company’s CLOT OUT first-in-human study evaluating safety and performance of the Clotild® Smart Guidewire System in large-vessel acute […]

DiaMedica Therapeutics Initiates Pivotal Trial of DM199 for the Treatment of Acute Ischemic Stroke

 The ReMEDy2 Trial Will Assess the Potential of DM199 to Both Improve Recovery After a Stroke and Prevent Stroke Recurrence Opportunity to Expand Therapeutic Treatment Window and Eligible Patient Population for Acute Ischemic Stroke for the First Time in Decades MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company […]

GNT Pharma Announces Approval of IND Application for the Phase III RODIN Trial of Nelonemdaz for Acute Ischemic Stroke Patients

PIII Study for 496 ischemic stroke patients treated with endovascular thrombectomy First multi-target neuroprotectant for the intervention of ischemic brain injury Safety and efficacy verified in two phase II studies for ischemic stroke patients with recanalization therapy YONGIN, South Korea, Sept. 08, 2021 (GLOBE NEWSWIRE) — GNT Pharma Inc. today […]

FDA Approves First-of-Its-Kind Stroke Rehabilitation System

SILVER SPRING, Md., Aug. 27, 2021 /PRNewswire/ — The U.S. Food and Drug Administration today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow […]

Q’Apel Medical Launches Armadillo – a New Radial Artery Access Platform to Meet the Needs of Physicians and Patients

Nationally there is a trend moving towards radial artery access versus femoral artery access for endovascular procedures, and Q’Apel Medical is leading the way. FREMONT, Calif., Aug. 23, 2021 /PRNewswire/ — Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, announced today […]

Helius Medical Technologies, Inc. Announces FDA Breakthrough Device Designation for the Treatment of Dynamic Gait and Balance Deficits Following a Stroke

NEWTOWN, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS™ device with the proposed indication for […]

Lumosa Therapeutics Announces Positive Results from LT3001 Phase 2a Clinical Trial in Acute Ischemic Stroke

LT3001 met primary safety endpoint. No symptomatic intracranial hemorrhage occurred. LT3001 showed pronounced neurological improvement in the majority of patients with baseline NIHSS ≥6 treated with LT3001. These data suggest that LT3001 has the potential to provide significant clinical benefit to patients up to 24 hours after the onset of […]