Labeling for pulse oximeters should carry warning labels alerting users the equipment may be less reliable in individuals with a darker skin tone, 25 state attorneys general said in a 1 November letter to US Food and Drug Administration commissioner Robert Califf.
News We’re Watching: AGs Push For Pulse Ox Warnings. VP Harris Announces AI Initiatives; FDA Looks At Digital Health And Diabetes
This week, 25 state attorneys general pressed FDA Commissioner Robert Califf to improve pulse oximeter safety warnings; MDIC extended the deadline on an industry cybersecurity benchmark study; and more guilty pleas and settlements were entered in Medicare fraud cases.
More from Regulation
New data-sharing framework signals a new era for health data exchange as EU initiatives to maximize its benefits kick into action.
The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.
Member states reported 309 significant cybersecurity incidents affecting the healthcare sector in 2023 – more than in any other critical sector.
The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.
More from Policy & Regulation
While the UK’s new plan to unlock public health data is a good start, complete, accessible data and regional computational infrastructure are needed to properly train AI for healthcare innovation, AI expert Muhammad Bilal tells Medtech Insight.
Member states reported 309 significant cybersecurity incidents affecting the healthcare sector in 2023 – more than in any other critical sector.
The US FDA has published warning letters to device firms Integra and Hologic. Both letters recount quality systems issues, with Integra’s centering on sterility while Hologic’s addresses a delay in noting safety signals from the company’s recalled BioZorb markers.