Lunit INSIGHT DBT receives FDA 510(k) clearance, poised to enter the world's largest DBT market SEOUL, South Korea, Nov. 14, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics...

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...