This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
Edwards Lifesciences has received US Food and Drug Administration (FDA) approval for the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed for paediatric patients with congenital heart disease who require pulmonary valve replacement. The AUTUS valve is designed to expand as a child grows. Its size can be increased through a minimally invasive transcatheter procedure...
VS3 Medical has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its investigational VS3 System, which is being developed to treat debilitating pulsatile tinnitus associated with venous sinus stenosis. Pulsatile tinnitus is a rhythmic sound that often matches the patient’s heartbeat....
Adaptyx Biosciences, a Stanford University spin-off developing wearable biosensing technology, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its continuous cortisol monitoring device....
Medtronic has received FDA clearance for its LigaSure RAS Maryland instrument for use with the Hugo robotic-assisted surgery (RAS) system in the US....
Powerful Medical has received FDA De Novo authorisation for Queen of Hearts, an AI-powered ECG model designed to identify findings associated with acute coronary syndrome (ACS), including...
Neola Medical AB has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for Neola®, a non-invasive technology designed for continuous lung monitoring in babies born prematurely....
CorTec’s Brain Interchange™ system has received a second Breakthrough Device Designation from the US Food and Drug Administration (FDA), this time for communication applications in people with non-progressive quadriplegia....
Innolitics and BEACON-Neuro.AI Inc. have partnered to advance BEACONPredict, an artificial intelligence (AI)-based software designed to predict the risk of malignant cerebral oedema following acute ischaemic stroke....
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....
