This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
BrainScope® has launched a new generation of its deep learning platform. The company, known for creating the first FDA-cleared AI/machine learning medical device in neurology, is building on its strong machine...
Guardant Health has announced that its Shield multi-cancer detection (MCD) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). ...
BiVACOR, a clinical-stage medical device company, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its innovative Total Artificial Heart (TAH)....
Vanderbilt Health has successfully implanted a novel heart monitoring device, the V-LAP, in a patient for the first time as part of an ongoing clinical trial. The study is currently being conducted at only five centres across the United States....
Elucent Medical, a company specialising in guided surgical technologies, has announced that its EnVisio X1™ In-Body Spatial Intelligence™ System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). ...
Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Anti-Factor Xa test developed for the FINDER® platform. This is the first point-of-care test designed to monitor heparin therapy, delivering results in under 15 minutes using only 50 microlitres of whole blood....
CGBIO has received Investigational Device Exemption approval from the US Food and Drug Administration for its bone graft substitute, NOVOSIS PUTTY. This approval allows the company to begin clinical trials in spinal fusion procedures in the United States....
Proprio has received its second 510(k) clearance from the FDA for its surgical guidance platform, Paradigm. This new clearance allows the inclusion of intraoperative measurements, making Paradigm...
Innoblative Designs has received Investigational Device Exemption approval from the U.S. Food and Drug Administration. This regulatory milestone allows the company to begin a feasibility study in the United States to assess the safety and effectiveness of its SIRA®...
Anuncia Medical has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its ReFlow® EVD. This device is designed to improve external ventricular drains (EVDs), which are used to manage brain...
