Based in Israel Scopio Labs announced that the FDA granted clearance to De Novo for its Full-Field Bone Marrow Aspirate (FF-BMA) software that provides AI-based decision support tools for bone marrow analysis.
The FF-BMA application allows analysis of bone marrow aspirate. 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 great detail. The company sells an app similar to the recently licensed app called Full Field Peripheral Blood Smear (FF-PBS) that is based on peripheral blood smears.
““Scopio’s full-field bone marrow aspiration application addresses the urgent need for digital innovation amid the increasing prevalence of hematologic conditions and healthcare demands,” said Adam Bagg, professor of pathology and laboratory medicine at the College of Perelman Medicine of the University of Pennsylvania and principal investigator on the bone marrow aspirate study said in a statement.
“By streamlining digital workflows and enabling one-time remote review of full swabs, we are hopeful that this technology can help improve efficiency across the board.”
Salt Lake City-based AI-powered brain health company Epitel received 510(k) clearance from the FDA for two devices: the REMI Remote Monitoring System for Outpatient and REMI Vigilenz for Event Detection.
REMI Ambulatory allows for extended EEG recording to allow patients to be monitored while they are at home and going about their daily lives. The software, which uses the same sensors as the company’s REMI for use in healthcare facilities, allows patients and caregivers to flag when a patient has a medical event or a suspicious event.
REMI Vigilenz AI for Event Detection is intended to help clinicians analyze EEG recordings obtained from the electroencephalogram (EEG) of the company’s REMI remote EEG monitoring system. The software does not draw diagnostic conclusions, but is supposed to aid the doctor’s professional judgment.
“Existing EEG monitoring systems have been cumbersome and restrictive for patients, and technical requirements and limitations have impeded providers’ ability to manage, record, and interpret EEGs. “REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions,” Mark Lehmkuhle, CEO and co-founder of Epitel, said in a statement.
Curio Digital Therapeutics, the New Jersey-based women’s digital health company, has received 510(k) clearance for MamaLift Plus, a prescription digital therapeutic for the treatment of postpartum depression.
MamaLift Plus, available by prescription only, is intended to treat patients 22 years of age and older with mild to moderate postpartum depression through neurobehavioral interventions that focus on addressing routine, maladaptive behaviors and dysfunctional thoughts.
Neurobehavioral treatments include behavioral activation therapy, cognitive behavioral therapy, dialectical behavioral therapy, and interpersonal therapy.
The offering is intended to be used in conjunction with 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 faced exclusively by women who have recently given birth,” Shailja Dixit, CEO and founder of Curio Digital Therapeutics, said in a statement.