FDA Approval

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...

Vabysmo (faricimab-svoa) targets and inhibits two disease pathways that drive wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet...

Interesting paper recently published looking at potential quality issues in breast whole slide images across three scanners used. While it appears there may be tissue missing from an image due to faint staining and often times nearly...