Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
The developers of an artificial intelligence-based diagnostic tool for musculoskeletal and neurological disorders need to change its marketing or stop distributing the product until it is approved under a PMA, a 10 February warning letter posted to the US Food and Drug Administration’s website this week states.
The Exer Scan from Denver-based Exer Labs Inc. is a mobile app that gathers real-time motion data to help clinicians...
The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
Worldwide medtech sales totaled $8.5bn in Q2, up 6.1%. Sales grew 8% in the US and 4.1% outside the US. Cardiovascular, surgery and vision were the primary growth drivers. Acquisitions and divestitures had net positive impact of 200 basis points, largely due to the acquisition of Shockwave Medical.
A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.
