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'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach

 
• By Shawn M. Schmitt

For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced by three distinct divisions across the US encompassing 20 FDA district offices on May 15. Check out the latest US map from the agency showing where the device divisions will be located, and find out what your firm will be facing at its next facility inspection.

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On the eve of US FDA rolling out an historic overhaul of its approach to facility inspections, the agency is finally offering a peek behind the curtain, giving details on how its "program alignment" scheme will operate and be structured.

The upshot: For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be...

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• By Natasha Barrow

Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.

Warning Letters - August 2025

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NextGen Dx Panel Expects Continued Limbo On LDT Regulation

 
• By Elizabeth Orr

A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.

More from Policy & Regulation

PathAI Expands AISight Dx Label With PCCP-Guided Addition Of Roche Scanners

 
• By Natasha Barrow

Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.

Small, Sleek, Ambitious: ViCentra Raises $85M To Develop Kaleido 2 Insulin Pump, Eyes US Market

 
• By Marion Webb

Dutch insulin pump maker ViCentra secured $85m to scale European manufacturing, preparing for the 2026 launch of its thinner, lighter Kaleido 2 pump and push into US market. CEO Tom Arnold said the pump has more than 3,500 users in Europe and expects “tens of thousands” in the next 18 months.

‘Serious Flaws’ In Medicare’s Proposal To Restart DME Competitive Bidding, AdvaMed Says

 
• By Brian Bossetta

A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.