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Diagnostics Have Evolved, So Too Has the VALID Act, Says FDA’s Hillebrenner

 
• By Brian Bossetta

As diagnostics have become more technologically advanced and are used more frequently in detecting diseases, uniform regulatory standards have become necessary, according to a panel of experts discussing testing reform at the MedTech Conference in Boston.

Lab Testing
• Source: Shutterstock

Lab results inform the majority of healthcare decisions, which is why patients relying on these tests need assurance that diagnostic outcomes are accurate.

At the same time, diagnostics are becoming ever more complex with the rapid advancement of technology

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More from Regulation

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

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

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

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