FDA
Aidoc has received FDA 510(k) clearance for its triage and notification of pneumothorax on X-ray exams.
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System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions
Linear Health Sciences has received U.S. FDA clearance and Health Canada approval of its Orchid SRV, a tension-activated breakaway safety release valve designed to reduce the...
Biosensors International has announced both the Japanese PMDA Approval for BioFreedom Ultra and US FDA Approval for BioFreedom.
Aidoc, the leading provider of healthcare AI solutions, announced today that it received its 9th FDA 510(k) clearance for triage and notification of brain...
Aidoc has received FDA 510(k) clearance for its triage and notification of pneumothorax on X-ray exams.
Optellum has attained CE marking for its Virtual Nodule Clinic - an AI-powered clinical decision support software that helps clinicians identify and track patients...
Prairie Village-based Artio Medical secured regulatory clearance for its first medical device. Founder and CEO Dr. Nick Franano talks about what the approval means...
CardioStory, a digital therapeutics start-up that employs non-invasive devices and data analytics to help treat patients, has received Breakthrough Device designation from the FDA...
This concise configuration, the first of its kind, is also expected to help reduce O.R. time and reflect savings related to cleaning and sterilization...
Saluda Medical has received full approval from the FDA for the Evoke Spinal Cord Stimulation (SCS) System.