Fasikl wins FDA nod for tremor-treating wearable wristband
July 2, 2025
Fasikl announced that it received FDA 510(k) clearance for its first-of-its-kind NeuroAI wristband for essential tremor.
Fasikl announced that it received FDA 510(k) clearance for its first-of-its-kind NeuroAI wristband for essential tremor.
PARIS and SAN FRANCISCO, July 2, 2025 /PRNewswire/ — Moon Surgical, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for two major advancements to its Maestro System: connectivity of the platform to power the Maestro Insights product and a Predetermined Change Control Plan (PCCP) to evolve its AI-powered ScoPilot product.
OSLO, Norway, July 1, 2025 /PRNewswire/ — SonoClear AS today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has designated the SonoClear® System as a Breakthrough Device for use in intracranial ultrasound procedures.
Regulatory Approval Paves the Way for U.S. Market Launch of Innovative Therapy Targeting Chronic Pain and Neurological Disorders
BOSTON, June 30, 2025 /PRNewswire/ — TOBY, Inc., a biotech startup advancing non-invasive cancer detection through urine-based volatilomics and Artificial Intelligence, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its TOBY Test for Bladder Cancer.
New treatment option offers continuous symptom control for patients with advanced Parkinson’s disease, enhancing quality of life through minimally invasive drug delivery
Designed for long-term monitoring and patient comfort, EmbraceMini sets a new benchmark in wearable technology for decentralized and real-world evidence studies.
Next-Generation Ankle Replacement Platform Designed to Improve Surgical Precision and Patient Outcomes in Orthopaedic Care
Breakthrough Integrated Sacral Neuromodulation Device Approved to Treat Urinary Urge Incontinence with a Minimally Invasive, Patient-Centric Approach
Next-Generation Stent Designed to Prevent Stroke by Combining Embolic Protection and Advanced Plaque Management in Carotid Artery Disease