CorTec gains FDA breakthrough designation for stroke rehabilitation BCI

CorTec's BCI aims to differentiate itself by offering brain-based communication alongside therapeutic neurostimulation.

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation

CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the ...
MobiHealthNews

CorTec becomes first German BCI company to get FDA Breakthrough designation

The company's brain-computer interface uses direct cortical electrical stimulation to help with motor recovery in people with ...
MassDevice

CorTec wins FDA breakthrough nod for BCI system

CorTec today announced that it received FDA breakthrough device designation for its Brain Interchange brain-computer ...
Nasdaq

GeneDx Granted FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ Testing

Designation highlights GeneDx innovation in clinical whole genome and whole exome testing and accelerates the pathway for FDA authorization of these novel diagnostic tests With more than 2.5 million ...
Endovascular Today

MicroPort NeuroScientific Apollo Dream Sirolimus Target-Eluting Stent Granted FDA Breakthrough Device Designation

MicroPort NeuroScientific Corporation announced that the company’s Apollo Dream sirolimus target-eluting stent system has b ...
Morningstar

FDA Grants Breakthrough Device Designation to MeMed BV Flex™ Capillary Blood

—Breakthrough Device Designation to streamline regulatory review and support a pathway toward broader reimbursement coverage— ANDOVER, Mass. and HAIFA, Israel, March 11, 2026 /PRNewswire/ -- MeMed, a ...
pressconnects

Micoy Therapeutics Receives FDA Breakthrough Designation for NeuroLume™ Test to Detect Folate Receptor Autoantibodies

NEW YORK, NY, UNITED STATES, January 12, 2026 /EINPresswire.com/ — Micoy Therapeutics today announced that the NeuroLume™ Test has been granted Breakthrough ...
Morningstar

Airiver Medical Granted FDA's Breakthrough Device Designation for Pulmonary Drug Coated Balloon to Treat Central Airway Stenosis; First Patient Treated in Clinical Trial

BROOKLYN PARK, Minn., March 4, 2026 /PRNewswire/ -- Airiver Medical, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, was granted ...
AZ Central

BioAgilytix Labs, Inc Receives FDA Breakthrough Device Designation for Anti-AAV Antibody Assay

FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for Friedreich ataxia. DURHAM, NC, UNITED ...