MedTech News
.................... by Andrew Celentano
MED-EL’s cochlear implants secure expanded approval in infants
MED-EL’s cochlear implants are now FDA-approved in children seven months and older with bilateral sensorineural hearing loss (SNHL).
Shoulder Innovations Partners with INS to Introduce a Robotic Platform for Shoulder Arthroplasty
Partnership will expand Shoulder Innovations’ Disruptive Ecosystem with Advanced Enabling Technology, Complementing Surgeon and Patient Needs in the ASC
BD Launches New Cell Analyser Configurations to Bring Cutting-Edge Capabilities to Labs
Three- and Four-Laser BD FACSDiscover A8 Cell Analysers Expand Accessibility of Spectral, Real-Time Imaging Cell Analysis
Biomoneta Healthtech Startup Receives US FDA Approval for Air-Decontamination Medical Device
The approval is a major endorsement of Biomoneta’s scientific breakthrough and an important inflection point for Beyond Next Ventures India (BNV India)
Axogen Announces FDA Approval of Biologics License Application for AVANCE
Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities
NeuroVice Announces PATI Now Available, Launches First FDA-Cleared Device Designed for Seizure Oral Injury Protection and Airway Management
Today, NeuroVice announced that PATI is now commercially available, marking a breakthrough moment for millions of patients living with focal and grand-mal seizures.
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.