Paige Lymph Node is recognized by the FDA as a breakthrough device to assist pathologists in the detection of breast cancer metastases in lymph node tissue NEW YORK--(BUSINESS WIRE)--Paige, a global leader in end-to-end digital...

Lumea: The FDA's recent move to treat Laboratory Developed Tests (LDTs) as medical devices has sent ripples through the industry. With the absence of a passed legislation in 2022, the FDA has taken a pivotal step, emphasizing its...

SigTuple: This innovative solution automates the microscopic examination of blood samples, enhancing efficiency and enabling remote pathology review. SigTuple, a medtech company that develops artificial intelligence (AI)-powered digital...

Dave Fornell | February 06, 2023 - There are now more than 520 marker-cleared artificial intelligence (AI) medical algorithms available in the United States, according to the U.S. Food and Drug Administration (FDA)...

Empatica: We are happy to announce the clearance of the Empatica Health Monitoring Platform by the U.S. Food and Drug Administration (FDA). The Empatica Health Monitoring Platform is our full-stack remote health monitoring and data...

Another manufacturer has FDA clearance for primary diagnosis for clinical use. Be sure to check out the NanoZoomer S260MD slide scanner for primary diagnostics.  Hamamatsu Photonics K.K., a global leader in imaging technology, today...