November 15, 2018
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
November 8, 2018
Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October.
Results generated by the algorithm-based software are...
July 18, 2018
Healthcare AI company Viz.ai announced today that it has raised $21 million in Series A funding. The investment was led by Kleiner Perkins, with additional participation from GV (formerly Google Ventures).
Viz.ai’s primary product is Contact, the first FDA-cleared clinical decision support (CDS) tool that analyzes CT results and highlights cases that may have experienced a stroke for review by a...
April 11, 2018
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
Since the Medical Device Amendments of 1976, a hallmark of FDA’s regulation of medical devices has been the agency’s risk-based approach....
February 6, 2018
Yesterday the Clinical Decision Support (CDS) Coalition released a comment broadly criticizing the FDA’s recent CDS draft guidance, noting that the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market.
“The resulting overregulation would be to the detriment of patient care,” CDS Coalition Leader...
February 3, 2011
Chilmark Research analyst Cora Sharma recently penned a thoughtful post on how mobiles might impact future meaningful use requirements -- and vice versa. Sharma sees future opportunities for mobile in data capture, advanced clinical processes, data sharing and patient engagement. Each of these have ties back to next stage meaningful use requirements.
"Hospitals worried about the compliance of...