medical devices | HiTech Service

A medical imaging machine dissolving from left to right into geometric data blocks, illustrating hardware becoming software

How Software Became a Medical Device

The Therac-25 reached the US market in 1983 by declaring itself equivalent to something already on sale. Forty years later, 97% of AI-enabled medical devices get there the same way. How the category was assembled backwards, one definitional crisis at a time.

On August 5, 2026
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A dominant teal radiology pie slice with an X-ray icon, next to smaller but rapidly growing slices for cardiology, neurology, and pathology with upward arrows

FDA’s AI Medical Device Approvals Aren’t Just Growing — They’re Finally Breaking Out of Radiology

Six AI medical devices got FDA clearance in 2015. Two hundred ninety-five got cleared in 2025. But the real story in the 2026 numbers isn't the growth rate — it's that radiology, which has dominated for a decade, is finally losing share.

On May 31, 2026
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A wearable smartwatch crossing a glowing dividing line on the ground, from a red regulated medical zone to a teal open wellness zone

FDA Just Redrew the Line for What Counts as a Medical Device — and a Lot of AI Health Products Just Landed on the Free Side

A blood glucose wearable can now be marketed as a general wellness product instead of a regulated medical device — the FDA's January 2026 guidance moves the line for AI health software further than most coverage let on.

On May 24, 2026
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