Feb. 12, 2024—Proscia has received FDA 510(k) clearance for its Concentriq AP-Dx diagnostic software for primary diagnosis.
“This regulatory milestone reflects our tireless commitment to our mission of perfecting cancer diagnosis,” David West, CEO of Proscia, said in a press release. “Pathologists are facing more pressure than ever before in the fight against some of humanity’s biggest challenges. With 510(k) clearance, we can help more laboratories improve the pathologist experience and better serve their patients.”
The software is cleared for clinical use with the Hamamatsu NanoZoomer S360MD slide scanner in the United States.