FDA Approved Many Medical Devices Without Making Clinical Data Public, Stat Investigation Finds
Companies are pitching their AI devices to patients and doctors who know very little about whether they will work or how they might affect the cost and quality of care, physicians and health data experts told Stat. An FDA official responded that a new “action plan’’ for regulating AI aims to force manufacturers to be more rigorous in their evaluations.
Stat:
As The FDA Clears A Flood Of AI Tools, Missing Data Raise Troubling Questions On Safety And Fairness
Artificial intelligence is the fastest-growing frontier in medicine, but it is also among the most lawless. U.S. regulators have approved more than 160 medical AI products in recent years based on widely divergent amounts of clinical data and without requiring manufacturers to publicly document testing on patients of different genders, races, and geographies, a STAT investigation has found. (Ross, 2/3)
Stat:
Explore STAT’s Database Of FDA-Cleared Artificial Intelligence Tools
The Food and Drug Administration has cleared scores of AI tools for use in the clinic, but there remains little publicly available data on how well those tools work on different groups of patients, a STAT investigation has found. (Ross, 2/3)
In other pharmaceutical and biotech industry news —
Stat:
Amid A Crush Of Covid-19 Research, Scientists Hone AI Tool To Screen Papers
Long before the pace of scientific publishing about Covid-19 broke land speed records, researchers were struggling to keep tabs on new studies in their fields. And to lighten the load, they’re increasingly turning to tools powered by artificial intelligence. (Palmer, 2/1)
Stat:
Who Will Vertex Buy? And How Much Might It Spend?
Who (or what) is Vertex Pharmaceuticals going to buy? The question — asked many different ways by analysts — dominated the company’s year-end earnings conference call on Monday evening. (Feuerstein, 2/2)
Stat:
Verily Spinout Onduo Expands Virtual Care To Spanish Speakers
The virtual care company Onduo is widening its reach: On Tuesday, the Alphabet-owned company announced it was bringing its chronic disease management platform to patients with certain cardiometabolic conditions, including hypertension and prediabetes. (Palmer, 2/2)
