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.

Regulatory News We're Watching
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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.

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Tarver Says Device Shortages For Pediatric Patients A ‘Growing Threat’

 

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.

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Start Using PMS Guidance Ahead Of June Regulation, Says UK MHRA

 
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The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

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UK NHS Must Capture Data For Next Generation Of AI In Healthcare

 

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.

EU Launches First Specific Plan On Cybersecurity For Healthcare Providers

 

Member states reported 309 significant cybersecurity incidents affecting the healthcare sector in 2023 – more than in any other critical sector.

Quality Systems Issues Take Center Stage In Integra, Hologic Warning Letters

 
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