FDA Approval

The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. This 240-slide scanner produces...

Since the 1990s, many innovators to Fortune 500 and Fortune 50 companies have worked to make digital pathology a reality. While not mainstream and perhaps less than 10% of US based pathology groups have any serious implementations of digital...

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...

Paige and Ohio State Wexner Medical Center: The Multi-Arm Study Will Utilize Paige Prostate Detect, the Only FDA Approved AI in Pathology for Detecting Prostate Cancer NEW YORK--(BUSINESS WIRE)--Paige, a global leader in end-to-end digital...