MedTech News
.................... by Andrew Celentano
mlHealth 360 Receives FDA Clearance for Scaida BrainCT-ICH: Canada’s First AI Solution for Intracranial Hemorrhage Triage
SURREY, BC, Dec. 4, 2025 /PRNewswire/ – mlHealth 360 today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K250694) for Scaida BrainCT-ICH, an AI-powered triage solution designed to address critical bottlenecks in acute care radiology.
Machine learning reveals how disordered protein regions contribute to cancer-causing condensates
Fusion oncoproteins arise when a gene fuses with another gene and acquires new abilities. Such abilities can include the formation of biomolecular condensates, “droplets” of concentrated proteins, DNA or RNA.
Natus announces FDA 510(k) clearance for electrographic status epilepticus diagnostic indication in BrainWatch point-of-care EEG solution
MIDDLETON, Wis., Dec. 3, 2025 /PRNewswire/ — Natus Medical Incorporated announced the electrographic status epilepticus diagnosis capability of its BrainWatch point-of-care EEG solution, featuring integrated Persyst analysis software which has received 510(k) clearance from the U.S. Food and Drug Administration.
Wingderm® Announces MDR Certification for Renuva 1550nm Non-Ablative Fractional Laser System
BEIJING, Dec. 3, 2025 /PRNewswire/ — Wingderm® announces that its Renuva 1550nm non-ablative fractional laser system has obtained MDR certification in the European Union, marking a significant regulatory milestone for the device within the EU market.
Carlsmed launches Aprevo platform for cervical fusion surgeries
Carlsmed (Nasdaq:CARL) announced today that it began the U.S. launch of its Aprevo technology platform for cervical fusion surgeries.
Medtronic gets FDA nod for Hugo surgical robot in urologic procedures
Medtronic (NYSE: MDT)+
announced today that the FDA cleared its Hugo robotic-assisted surgery system for use in urologic surgical procedures.
MIT chemists synthesize a fungal compound that holds promise for treating brain cancer
Preliminary studies find derivatives of the compound, known as verticillin A, can kill some types of glioma cells.
New bioadhesive strategy can prevent fibrous encapsulation around device implants on peripheral nerves
Inspired by traditional acupuncture, the approach has potential to impact all implantable bioelectronic devices, enabling applications such as hypertension mitigation.