This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
Maverix Medical has received US Food and Drug Administration (FDA) 510(k) clearance for its Maverix Narwhal™ Cryo System, a single-use flexible cryoprobe designed for interventional lung procedures....
Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its investigational SimpleScreen™ Lung blood-based screening test....
Bracco Imaging has secured 510(k) clearance from the US Food and Drug Administration (FDA) and authorisation from Health Canada for VueJect®, a dedicated ultrasound contrast delivery system designed for cardiac imaging....
Atlantic Health and K Health have launched Atlantic Health PatientGPT and Virtual Primary Care to improve digital access to healthcare and help patients connect with appropriate clinical services....
ThinkSono has received 510(k) clearance from the US Food and Drug Administration (FDA) for ThinkSono Guidance, an AI-powered software designed to help non-ultrasound-trained healthcare professionals...
Beacon-Neuro.AI Inc., a Washington University in St. Louis startup, has received FDA Breakthrough Device designation for BeaconPredict, an artificial intelligence (AI)-powered software platform designed to predict malignant cerebral oedema following acute stroke....
Aidoc has received FDA Breakthrough Device Designation for First Read, an artificial intelligence (AI)-powered solution designed to support chest X-ray analysis and generate preliminary radiology report text....
Hilo, a health technology brand developed by Aktiia, has introduced Hilo Core in the U.S., a long-term blood pressure monitoring system designed to provide continuous insights into cardiovascular health....
TETmedical, Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its NSE-FAST® (Neuron Specific Enolase – Functional Activity Stroke Test), a rapid blood-based diagnostic assay developed to support the diagnosis of acute ischaemic stroke....
Florida State University (FSU) and Sky Therapeutics have secured U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Cenextra, a digital therapy designed to improve executive functioning...
