MedTech News
Moon Surgical Receives FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
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.
Lifecare takes next steps in CGM implant development
Lifecare said on social media that it completed a significant milestone in the development of its continuous glucose monitor (CGM) implant.
SonoClear AS Receives FDA Breakthrough Designation for SonoClear® System
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.
EmpNia Receives FDA Clearance for eMotus™ Neuromodulation System
Regulatory Approval Paves the Way for U.S. Market Launch of Innovative Therapy Targeting Chronic Pain and Neurological Disorders
MIT engineers develop electrochemical sensors for cheap, disposable diagnostics
Electrodes coated with DNA could enable inexpensive tests with a long shelf-life, which could detect many diseases and be deployed in the doctor’s office or at home.
Virtual reality software uncovers new details in pediatric heart tumors
New cutting-edge software developed in Melbourne can help uncover how the most common heart tumor in children forms and changes. And the technology has the potential to further our understanding of other childhood diseases, according to a new study.
AI performs virtual tissue staining at super-resolution
Traditional histopathology, crucial for disease diagnosis, relies on chemically staining tissue samples to highlight cellular structures for microscopic examination by pathologists. This labor-intensive “histochemical staining” process is time-consuming, costly, requires chemical reagents, and is destructive to the tissue.
FDA Grants Breakthrough Device Designation to TOBY’s AI-Powered Urine Test for Early Bladder Cancer Detection
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.