The era of regulatory flexibility for laboratory-developed diagnostics is rapidly drawing to a close, fundamentally reshaping the field for digital pathology and AI-driven diagnostic tools.…
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8 min read
The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database has been consolidated into the new Adverse Event Monitoring System (AEMS) as of March 2026.…
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7 min read
Poor user interface design in Software as a Medical Device (SaMD) is not merely an inconvenience. It can lead to catastrophic clinical errors. This makes…
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7 min read
The promise of artificial intelligence in healthcare hinges not just on technological sophistication, but on its equitable application across the diverse patient populations it aims…
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8 min read
Algorithmic drift can quietly compromise patient safety as clinical demographics shift over time, leading to a silent erosion of an AI model’s intended performance. This…
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7 min read
Can a physician legally and safely rely on an AI recommendation they cannot explain? This question, once confined to academic discourse, now sits squarely at…
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7 min read
FDA clearance pathways often feel like a black box, especially for digital health startups. But for any healthcare venture capitalist or corporate strategy lead, the…
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7 min read
The FDA has harmonized its Quality System Regulation (QSR) with the international standard ISO 13485, and the new Quality Management System Regulation (QMSR) is now…
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8 min read
The regulatory field for medical device software is in upheaval, and if you’re a quality assurance manager or on the legal team, you need to…
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8 min read
The line between a health app and a regulated medical device isn’t just for lawyers to debate. For health tech founders, it’s the whole ballgame,…
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9 min read