Neuro

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 […]

Synchron Secures $40M in Series B led by Khosla Ventures to Launch U.S. Clinical Trials of Minimally Invasive Brain Computer Interface

Synchron’s flagship StentrodeTM endovascular implant does not require open brain surgery and has obtained FDA Breakthrough Device Designation for the treatment of paralysis The New York based company is already conducting human trials in Australia and is expected to commence a U.S. clinical trial in 2021 NEW YORK–(BUSINESS WIRE)–Synchron, a brain […]

IRRAS Announces Notified Body Transition from GMED to DEKRA, a Global Leader in Inspection and Certifications

STOCKHOLM, May 11, 2021 /PRNewswire/ — IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the CE Mark certificates for its IRRAflow system and the company’s ISO13485:2016 certification have been transferred to a new notified body, DEKRA. After the successful completion of […]