Neuro

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 […]

Synchron Receives Green Light From FDA to Begin Breakthrough Trial of Implantable Brain Computer Interface in US

Clinical trial to pave the way for Synchron’s StentrodeTM to become first commercially available implantable brain computer interface NEW YORK–(BUSINESS WIRE)–Synchron, a venture-backed brain data transfer company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for its flagship product, the StentrodeTM motor […]

Balt Completes Enrollment in FIRST: A Multi-center, Prospective, International Study of Low Profile Silk Vista Flow Diverters

Study to confirm clinical benefit of Silk Vista and Silk Vista Baby in a wide range of anatomical locations BOSTON, July 28, 2021 (GLOBE NEWSWIRE) — Balt, an innovative neurovascular company focused on developing, designing, and manufacturing solutions for treating complex, life-threatening conditions, including stroke, aneurysms, and arteriovenous malformations, today […]

Ischemia Care Announces Industry and Hospital Program to Support Molecular Diagnostic Testing in Ischemic Stroke

OXFORD, Ohio–(BUSINESS WIRE)–Ischemia Care today announced a new program called “CLASSICS,” which stands for Clinical Laboratory and Strategic Support to Identify Stroke and Cause of Stroke to commercialize a portfolio of hospital-based blood tests across industry leading laboratory platforms for ischemic stroke and underlying causes (such as atrial fibrillation) used in the hospital setting. According to the CDC […]

Robocath and Rennes University Hospital launch co-development research program into treatment of strokes in partnership with Philips France

Rouen and Rennes, France, July 7, 2021 – Robocath, a company that designs, develops and commercializes robotic solutions to treat cardiovascular diseases, and Rennes University Hospital, today announce the launch of a co-development research program using robotics to improve treatment for stroke victims.   With the support of Philips France, this unique […]

Philips announces first patient enrolled in the WE-TRUST global multicenter stroke study to assess the impact of the Direct to Angio Suite workflow in improving patient outcomes

July 7, 2021 First patient enrolled in global multi-center randomized controlled trial with 564 patients at 15 sites comparing the impact of the Direct to Angio Suite workflow (diagnosis and treatment in the angio suite) to the conventional workflow (diagnosis in the CT or MRI suite followed by treatment in […]

Sensome Receives FDA “Breakthrough Device Designation” 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 it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for its Clotild® Smart Guidewire System designed […]

RapidAI Announces New Continuing Education Credits

Leader in Cerebrovascular and Vascular Imaging Expands Clinical Learning and Development Offerings through Rapid U Program SAN MATEO, Calif., June 8, 2021 /PRNewswire/ — RapidAI, the leader in clinical learning and development for stroke, aneurysm, and other cerebrovascular and vascular conditions, today announced the availability of Continuing Education (CE) and Continuing Medical Education […]

ABBOTT RECEIVES EUROPEAN AND CANADIAN APPROVAL FOR AMPLATZER™ STEERABLE DELIVERY SHEATH TO OPTIMIZE LEFT ATRIAL APPENDAGE CLOSURE PROCEDURES FOR PEOPLE AT RISK OF STROKE

– First-of-its-kind steerable delivery system designed for left atrial appendage (LAA) occluder to seal the LAA in people who are at increased risk of stroke due to atrial fibrillation – New delivery system works with Abbott’s leading Amplatzer Amulet™ LAA Occluder device to enable better access to the LAA and […]