Medical device makers have seen a productive summer with warm receptions at FDA for Artificial intelligence (AI) enabled devices. Over the last five weeks, a number of De Novo classifications and 510(k) clearances granted by FDA cover a number of novel and innovative devices to address conditions related to the detection of cardiovascular abnormalities, cognitive behavioral therapy (CBT) for diabetics, risk assessment for diabetes and improving the availability of cardiovascular ultrasound imaging personnel. These recent clearances include:
Viz.ai HCM AI powered software algorithmically scans 12-lead hospital ECGs to aid in the detection of subtle signs of thickened cardiac tissue in adult patients, which can be indicative of hypertrophic cardiomyopathy (HCM), a serious condition which can be difficult to diagnose and is one of the leading causes of sudden cardiac death for people under age 35. Viz.ai announced the HCM device was developed in partnership with Bristol Myers Squibb, who is developing medications that could reduce the need for surgical intervention to address severe and obstructive HCM.
Better Therapeutics AspyreRx digital therapeutic product is a software device that provides digital behavioral therapy to aid in the management of type 2 diabetes. Current standard of care has patients meet with their clinician to guide them to change behaviors with cognitive behavioral therapy (CBT) to alter the course of their disease. AspyreRx opens the opportunity for patients to receive this interactive experience via a mobile app that uses artificial intelligence to personalize each patient’s CBT treatment plan to help reduce their HbA1c. Better anticipates launching the product in the 4th quarter of this year.
Renalytix KidneyIntelX.Dkd is a prognostic test for the assessment of chronic kidney disease progression, which is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. KidneyIntelX.dkd platform combines blood-based biomarkers with clinical variables using an artificial intelligence enabled algorithm, intended to stratify patients with type 2 diabetes and early stage chronic (diabetic) kidney disease into three risk levels of low, medium or high. The KidneyIntelX.dkd device received a coveted Breakthrough Device Designation prior to this clearance and is based on technology developed at the Icahn School of Medicine at Mount Sinai in New York NY, and licensed to Renalytix.
UltraSight AI Guidance is a radiological acquisition and/or optimization guidance system that is intended to aid in the acquisition and/or optimization of ultrasound images. The UltraSight real-time AI guidance software can aid medical professionals without sonography experience in acquiring cardiac transthoracic echo images in multiple settings, allowing for more widespread detection of heart disease and providing patients easier access to cardiac monitoring.
