Scopio Labs, an imaging and analysis focused medtech company based in Israel, have received De Novo FDA clearance for its artificial intelligence (AI)-driven bone marrow aspirate analysis software.
Bone marrow samples are important for diagnosing a range of different blood disorders such as different blood cancers, but standard methods of analyzing these samples are time consuming and rely on the skills, knowledge and in-person presence of trained hematopathologists to ensure accuracy.
Scopio produces two machines, one designed for smaller labs and lower throughput and a higher throughput machine, that are able to image blood and other cells in high detail.
The newly approved full-field bone marrow aspirate application uses AI to analyze thousands of cells in each bone marrow sample quickly and provide decision support for clinicians and lab scientists.
The company already has a similar, approved application based on peripheral blood smear that also uses AI to help provide decision making support. According to Scopio, this application reduces turnaround time for peripheral blood smear reviews by 60%. Both applications are designed to work with imaging scans from the company’s machines.
A key advantage of this system is that the 100x cell images from either application can be securely reviewed externally, meaning a second opinion can be sought without the expert needing to be there in person.
This is the first time a bone marrow analysis digital analysis application has been FDA approved and for this reason, the company applied for a De Novo classification request, which the regulatory authority defines as “a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.”
There is a known shortage of trained pathologists in the U.S. so technology like this that can help speed up the diagnostic process while also retaining accuracy is valuable.
“By harnessing AI and full-field imaging, labs can streamline workflows, reduce operational costs, and enhance patient care,” said Itai Hayut, CEO of Scopio Labs, in a press statement.
“Scopio’s full field bone marrow aspirate application addresses the urgent need for digital innovation amid the rising prevalence of hematologic conditions and healthcare demands,” added Adam Bagg, a professor of pathology and laboratory Medicine in the Perelman School of Medicine at the University of Pennsylvania and a lead investigator in the bone marrow aspirate study that was submitted to the FDA.
“By optimizing digital workflows and enabling unique remote review of entire smears, we are hopeful this technology can help enhance efficiency across the board.”
