This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
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....
W. L. Gore & Associates Medical Products has received CE Mark approval under the Medical Device Regulation (MDR) for the GORE® VIABAHN® FORTEGRA Venous Stent. The device is indicated for treating symptomatic inferior vena cava and iliofemoral venous outflow obstruction. The approval follows its recent...
HeartSciences Inc., a healthcare information technology company specialising in artificial intelligence-enabled electrocardiography, has launched MyoVista Insights™ version 1.3. The latest update introduces the MyoVista Insights AI-ECG Algorithm Marketplace, enabling third-party AI-ECG algorithms to be integrated into the platform....
Cardiosense has received De Novo classification from the U.S. Food and Drug Administration for its PCWP Analysis Software™,...
Coredio has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Cardiac Performance Simulation Engine, a software-based platform developed to support heart failure assessment....
FX Shoulder Solutions has obtained U.S. FDA 510(k) clearance for the FX V135® Easytech Shoulder System, an advanced shoulder replacement platform developed to enhance surgical flexibility and efficiency....
RIVANNA has received U.S. FDA 510(k) clearance for its Accuro® XV Diagnostic Ultrasound System, allowing the company to commercially offer the device for musculoskeletal imaging in hospitals and medical clinics....
