GlobalData on MSN

Aurenar wins breakthrough designation for cerebral vasospasm neuromodulation platform

Aurenar’s V-Link system uses transauricular vagus nerve stimulation to modulate brain inflammation in patients that have ...

Aid for brain-bleed recovery receives expedited review

A noninvasive neuromodulation technology has received Breakthrough Device Designation from the U.S. Food and Drug ...
GlobalData on MSN

SkylineDX’s predictive melanoma test secures FDA breakthrough designation

SkylineDX’s test stratifies cutaneous melanoma patients into metastatic risk categories to inform treatment decisions.

Aurenar Receives FDA Breakthrough Device Designation for Non-Invasive Neuromodulation Therapy Designed for the Reduction of Cerebral Vasospasm Following Brain Hemorrhage

Aurenar, developer of a non-invasive neuromodulation platform for patients in intensive care, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device ...
Nasdaq

Orchestra BioMed Receives FDA Breakthrough Device Designation for Atrioventricular Interval Modulation Therapy to Address Uncontrolled Hypertension

Orchestra BioMed has announced that the FDA has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating over 7.7 million U.S. patients ...
MedTech Dive

Aidoc wins breakthrough nod for AI that reads chest X-rays

Aidoc is working on an artificial intelligence feature that would analyze chest X-rays and generate preliminary reports for ...
MobiHealthNews

FDA grants Aurenar breakthrough status for brain-bleed device

The V-Link System is designed to reduce cerebral vasospasm after aneurysmal subarachnoid hemorrhage by stimulating the vagus nerve through the outer ear.

Aidoc Receives FDA Breakthrough Device Designation for AI That Drafts Radiology Reports

Aidoc, the clinical AI company supporting diagnostic decisions across nearly 2,000 hospitals worldwide, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device ...
Morningstar

Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss

The Smart Neurostimulation System is the first neurostimulation device to receive Breakthrough designation for TBI-related memory loss; the implant decodes memory states from neural activity on 60 ...
Nasdaq

FDA Grants Breakthrough Device Designation to Guardant Health’s Shield Multi-Cancer Detection (MCD) Test

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted ...