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US Legislators Weaving Cybersecurity, National Stockpile Care Into Pandemics Bill

 
• By Sue Darcey

House Energy and Commerce Committee members crafting a pandemic-planning reauthorization bill are adding device cybersecurity details to the language to help maintain the nation’s stockpile of countermeasures to infectious disease outbreaks and chemical, nuclear and biological attacks.

US lawmakers working to reauthorize a pandemic preparedness bill known as “PAHPA” plan to add provisions on maintaining cybersecurity in medical devices purchased for the national stockpile of emergency countermeasures. But recent changes in FDA authority over software products raise some questions with the issue.

Devices, personal protective equipment, pharmaceuticals and vaccines are part of the stockpile maintained by federal agencies in the case of...

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Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Scores Of Companies On Board With Medicare Data Interoperability And Digital Health Initiative

 
• By Brian Bossetta

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

More from Digital Technologies

SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test

 
• By Marion Webb

Among early cancer screening tests, SpotitEarly stands out by combining dogs’ superior sense of smell with machine learning. SpotitEarly plans two US clinical trials for breast and lung cancer aiming to seek FDA clearance, but needs more funding to support clinical development and commercialization.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 
• By Natasha Barrow

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Scores Of Companies On Board With Medicare Data Interoperability And Digital Health Initiative

 
• By Brian Bossetta

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.