This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
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...
ElectroWire Medical has received U.S. Food and Drug Administration (FDA) clearance for its LightningWire™ Transseptal Puncture System, marking an important regulatory milestone for the company's cardiovascular device portfolio....
Aidoc has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for First Read, an artificial intelligence solution created to assist radiologists by analysing chest radiographs and producing an initial draft of radiology reports. T...
Serenity Medical has secured Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Serenity Shepherd Stent™ System, reinforcing its progress in the development of neurovascular devices for venous sinus disorders....
Grey Matters Health Inc. has installed its first brain-dedicated Positron Emission Tomography (PET) scanner at its flagship NovaScan Neuroimaging Clinics™ facility in Davie, Florida, supporting the company's expansion into specialised neuroimaging services in the US....
United Therapeutics Corporation has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its LungFX device, enabling centralised ex vivo lung perfusion (EVLP) to assess donor lungs outside the body before transplantation....
