This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
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....
Corify Care has received clearance from the US Food and Drug Administration for its ACORYS® System, a breakthrough non-invasive cardiac mapping platform designed to provide real-time four-dimensional electroanatomical mapping of the heart....
Xodus Medical has received FDA 510(k) clearance for the Hot Pink Pad®, a novel patient temperature management and positioning system developed to improve surgical safety and operating room efficiency....
GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration for its Photonova Spectra photon-counting CT system, marking a key step towards its commercial launch in the United States....
Algernon Health Inc. has launched NovaScan Neuroimaging Clinics™ as the new brand for its planned network of brain PET scanning centres in the United States....
Hyperfine, Inc has obtained CE Marking and UK Conformity Assessment (UKCA) approval for its next-generation Swoop® system and the latest advancement in its Optive AI™ software....
Neuropacs™ Corp has received De Novo classification from the U.S. Food and Drug Administration (FDA) for neuropacs™, a diffusion MRI–based diagnostic aid designed to support the evaluation of Parkinsonian syndromes....
