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PDUFA First: Fees To Support US FDA Device Center Staff

 
• By Derrick Gingery

To enhance combination product reviews, drug-fee revenue will pay for related positions in the agency's Center for Devices and Radiological Health.

Drug user-fees will support staff in US FDA's device center for the first time beginning in fiscal year 2018.

The move does not stem from altruism by pharmaceutical sponsors and FDA signing on to the PDUFA VI agreement

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Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

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EU Pilots Streamlined Approach To Multinational Combination Product Trials

 
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EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

More from Device Area

The Value Of Consumer Wearables Within The Clinic Is Currently Unknown, Says Cardiologist

 
• By Natasha Barrow

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
• By Marion Webb

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.