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To help prevent the approval of AI medical devices that “mirror or exacerbate” existing health disparities, the FDA should develop a “distinct regulatory process” for artificial intelligence (AI)-driven software as a medical device (SaMD), say several academic researchers.
BlueStar Telehealth reported that its in-home remote patient monitoring program (RPM) using SmartMeter’s iBloodPressure cellular-connected blood pressure devices saw improvements in all patients with uncontrolled hypertension.
In a postmarket study, IRRAS’s IRRAflow fluid exchange system more effectively removed blood from chronic subdural hematomas (cSDH) and reduced catheter-related infections when compared to passive drainage alone, researchers reported in the journal Operative Neurosurgery.
aragonix Technologies’ LUNGguard donor lung preservation system recently saw its first use for a pediatric case in which donor lungs procured overnight were preserved with the system, allowing for next day transplant surgery.
Dermalyser, an artificial intelligence (AI) skin cancer diagnostic tool from Swedish start-up AI Medical Technology, diagnosed melanoma-suspected cutaneous lesions with high accuracy in a 240-patient clinical trial conducted at 37 primary care settings in Sweden.
Currently, “there is no clinically accepted method of continuous beat-to-beat blood pressure monitoring that patients can use outside of the hospital setting,” said the consortium’s leader.
Diabetics using LifeScan’s Bluetooth-connected blood glucose monitor (BGM) in conjunction with a diabetes management digital app experienced better blood sugar control, lowered hyperglycemic readings, and significantly reduced mean glucose, the company reported in the Journal of Diabetes and Technology. Read More
Stroke-specific machine learning algorithms were no better at predicting stroke risk than self-reported risk factors and were worse in predicting stroke risk in Black patients than in White patients, according to a new study published in JAMA Network.