MedTech News
New hope for early pancreatic cancer intervention via AI-based risk prediction
MIT CSAIL researchers develop advanced machine-learning models that outperform current methods in detecting pancreatic ductal adenocarcinoma.
FDA approves expanded MRI labeling for Abbott Proclaim neurostim
Abbott (NYSE: ABT)+
announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system.
Imvaria and Darmiyan receive FDA authorizations for AI-enabled diagnostic tools
The de novo classifications cover software for detecting a lung condition and assessing dementia risk.
NeuroSigma Announces FDA Clearance of its Second-Generation Monarch eTNS System for Treating Pediatric ADHD
NeuroSigma today announced that the U.S. Food and Drug Administration (FDA) cleared use of NeuroSigma’s second-generation Monarch eTNS System for treating pediatric attention deficit hyperactivity disorder (ADHD)
Clarius wins CE mark for handheld full-body ultrasound tech
Clarius Mobile Health announced today that it received CE mark approval for its wireless handheld whole-body ultrasound scanner.
FDA clears DermaSensor AI-powered skin cancer detection device
DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.
Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions
Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System.
ClearPoint Neuro Announces FDA Clearance for SmartFrame OR™ Stereotactic System
Limited Market Release of First Purpose-Built OR Product to Begin in First Half of 2024