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Proscia: Key regulatory milestone advances company’s mission to perfect cancer diagnosis. PHILADELPHIA – February 12, 2024 – Proscia®, a leading provider of digital and computational pathology solutions, has received 510(k) clearance...

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)...

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