Kallisio recently announced that the FDA has cleared its 3D-printed Stentra, used to protect head and neck cancer patient’s healthy tissue during radiation therapy.
Thirona announced today that it received FDA 510(k) clearance for the latest update of its AI-based LunQ clinical software.
Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device.
Abbott (NYSE: ABT)+
announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system.
The de novo classifications cover software for detecting a lung condition and assessing dementia risk.
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)
DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.
Limited Market Release of First Purpose-Built OR Product to Begin in First Half of 2024
Zeiss Medical Technology announced that the FDA approved the VisuMax 800 with Smile Pro software.
Neuralace Medical announced today that it received FDA clearance for its chronic painful diabetic neuropathy (PDN) treatment.