Neuro

Imperative Care Secures FDA 510(k) Clearance for the Zoom System, Including the First Large-Bore .088” Catheter for Aspiration When Used with the Zoom Catheters, for Stroke Treatment

CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc. today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s Zoom System, making it the first comprehensive stroke thrombectomy system to include large-bore .088” catheters indicated for both access and aspiration when used with a Zoom Catheter. This clearance […]

MedRhythms’ InTandem® Rehabilitation System for Chronic Stroke Gait Impairment Receives Final Medicare Payment Determination from CMS

The pricing determination for HCPCS code E3200 will take effect on April 1, 2025 PORTLAND, Maine, Jan. 16, 2025 /PRNewswire/ — MedRhythms, Inc. today announced that InTandem®, the company’s flagship rehabilitation system for chronic stroke gait impairment, received a final pricing…

Radical Catheter Technologies’ 8F Neurovascular Catheter Receives US FDA 510(k) Clearance, Second for the Best-in-Class Ribbon Technology Platform

Company Announces New Headquarters, a State-of-the-Art Manufacturing Facility to Expand Commercialization of the Radical Neurovascular Catheter Portfolio to Include a Wide Range of Sizes and Indications Enhancing Efficiency and Precision in Neurosurgery Company Announces New Headquarters, a State-of-the-Art Manufacturing Facility to Expand Commercialization of the Radical Neurovascular Catheter Portfolio to Include a Wide Range of Sizes and Indications Enhancing Efficiency and Precision in Neurosurgery

TargED Biopharmaceuticals doses first participant in Phase 1 clinical trial of TGD001, a groundbreaking thrombolytic in acute ischemic stroke (AIS) and TTP

TGD001 is being developed to offer patients with clotting disorders a faster, safer and more effective treatment than today’s standard of care – saving lives and reducing disability Following the Phase 1 safety study, TargED intends to further develop TGD001 in patients with AIS and iTTP…

Neuvotion Expands Partnership with Intelligent Product Solutions and Commercializes NeuStim™ Technology for Stroke and Spinal Cord Injury

STAMFORD, Conn., Dec. 17, 2024 /PRNewswire/ — Neuvotion, Inc. is an early-stage medical device company developing AI-driven neuromodulation technologies and products for use in the neurorehabilitation, brain-computer interface (BCI), and physical therapy markets. Today Neuvotion has…

RapidPulse Receives FDA Approval to Begin IDE Study in Ischemic Stroke Using Innovative Cyclic Aspiration System – Recently Completed Clinical Trial Shows Significantly Higher First Pass and Frontline Success Rates

MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) — RapidPulse, Inc., a Delaware corporation headquartered in Miami, Florida focused on improving the treatment success rate for acute ischemic stroke (AIS) announced that the United States Food and Drug Administration (FDA) agreed that RapidPulse can begin enrollment in an Investigational Device Exemption (IDE) study of its novel and precise cyclic aspiration system. This will allow U.S. and European patient enrollment in 2025 to commence in a study designed to demonstrate the RapidPulse patented method of precisely pulsed aspiration is safe and effective in the treatment of AIS. RapidPulse’s technology is a spin-out of Syntheon 2.0, LLC, an innovative medical device incubator with a long track record of successful exits.

Balt Announces Publication in New England Journal of Medicine of The Squid Trial for the Embolization of the Middle Meningeal Artery (STEM) for the Treatment of chronic Sub-Dural Hematoma

BOSTON, Nov. 21, 2024 (GLOBE NEWSWIRE) — Balt, Inc., a global technology leader in neurovascular devices, today announced the publication of The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma in the New England Journal of Medicine. The study shows that among patients with symptomatic chronic subdural hematoma (cSDH), adjunctive middle meningeal artery (MMA) embolization resulted in a lower risk of treatment failure than standard treatment alone, without resulting in an increased incidence of disabling stroke or death in the short term. STEM is the first randomized prospective IDE trial investigating embolization of the MMA for the treatment of cSDH.