FDA Approval

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...

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...