Israel-based Scopio Labs announced the FDA granted De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) software that provides AI-enabled decision support tools for bone marrow analysis.
The FF-BMA application allows for bone marrow aspirate analysis. It combines full-field imaging and an AI-powered decision support system that allows hematopathologists to analyze bone marrow smears remotely.
Scopio Labs produces machines that process blood and other cells in high detail. The company sells an application that is similar to the newly cleared application called Full-Field Peripheral Blood Smear (FF-PBS) that is based on peripheral blood smears.
“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,” Adam Bagg, professor of pathology and laboratory medicine in the Perelman School of Medicine at the University of Pennsylvania and lead investigator in the bone marrow aspirate study, said in a statement.
“By optimizing digital workflows and enabling unique remote review of entire smears, we are hopeful this technology can help enhance efficiency across the board.”
Salt Lake City-based AI-enabled brain health company Epitel received FDA 510(k) clearance for two devices: REMI Remote Monitoring System for Ambulatory and REMI Vigilenz for Event Detection.
REMI Ambulatory allows for extended EEG recording to allow patients to be monitored while at-home and going about their daily lives. The software, which uses the same sensors as the company’s REMI for Healthcare Facility Use, allows patients and caregivers to mark when a patient has a medical event or suspected event.
REMI Vigilenz AI for Event Detection is meant to help clinicians analyze EEG recordings obtained from the company’s REMI Remote EEG Monitoring System electroencephalogram (EEG). The software makes no diagnostic conclusions, but is supposed to aid clinician’s professional judgment.
“Existing EEG monitoring systems have been cumbersome and restrictive for patients, and technical requirements and limitations have impeded providers’ ability to administer, record, and interpret EEG. REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions,” Mark Lehmkuhle, CEO and cofounder of Epitel, said in a statement.
New Jersey-based digital women’s health company Curio Digital Therapeutics received 510(k) clearance for MamaLift Plus, a prescription digital therapeutic for the treatment of postpartum depression.
MamaLift Plus, available through prescription only, is intended to treat patients 22 and over with mild to moderate postpartum depression using neurobehavioral interventions that focus on addressing routine, maladaptive behaviors and dysfunctional thoughts.
Neurobehavioral treatments include behavioral activation therapy, cognitive behavioral therapy, dialectical behavior therapy and interpersonal therapy.
The offering is intended to be used alongside outpatient care and is available on any smartphone or tablet.
“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health. MamaLift Plus is the first and only digital solution that can help address the serious unmet need uniquely faced by women who have recently delivered,” Shailja Dixit, CEO and founder of Curio Digital Therapeutics, said in a statement.
