MedTech News
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
FDA approves Zeiss software that treats nearsightedness
Zeiss Medical Technology announced that the FDA approved the VisuMax 800 with Smile Pro software.
FDA clears painful diabetic neuropathy neurostim therapy from Neuralace
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment.
Zeta Surgical wins expanded FDA nod for mixed reality navigation system
Zeta Surgical announced today that the FDA granted it a special 510(k) clearance for expanded software functionality.