by admin | Sep 17, 2019 | FDA
GE Healthcare has received 510(k) clearance for AI algorithms designed to detect a type of collapsed lung on x-ray images. The FDA clearance covers a set of algorithms that GE has embedded in its Optima XR240amx mobile x-ray device, thereby enabling hospitals to...
by admin | Sep 14, 2019 | FDA
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in...
by admin | Sep 12, 2019 | FDA
Checkpoint Surgical, a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief...
by admin | Sep 6, 2019 | FDA
Prescient Metabiomics has received FDA breakthrough status for its non-invasive colorectal cancer test. The test, called LifeKit Prevent, identifies microbial DNA and RNA biomarkers associated with the new, abnormal growth of tissue in the gastrointestinal tract. By...
by admin | Aug 11, 2019 | FDA
Binx Health, the pioneer in anywhere, anytime testing for women’s health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first-of-kind, highly sensitive and specific, molecular point-of-care...
