FDA-authorised AI-enabled devices, growth

consistent with normal70/95coincident

1What this measures

Year-on-year growth in the cumulative count of AI-enabled medical devices with an FDA final decision, from the FDA's published list. Derived metric fda_ai_devices_yoy.

Why it matters. The clearest regulated-domain speed limit with an official monthly series; the paper predicts slow diffusion in high-consequence tasks and this is the count of what gets through.

Proxy types: policy
Unit: pct_change_yoy
Cadence: quarterly
Valve: adoption to adaptation

2How we track this

derived metric fda_ai_devices_yoy (formula in the semantic layer)

Normal band: ≤ 50.0%
Fast band: ≥ 100.0%
Falsifying: —

Normal = the cumulative count growing under 50% a year (the 2019-2024 pace); fast = doubling or faster, which is what an ungated regulated domain would show. Between is emerging.

Applied to metric:fda_ai_devices_yoy.

3Tracker interpretation

Authorisations are mostly radiology CAD tools; the list says what clears review, not what is used at the bedside.

4Evidence

Latest point

26.7%as of 2026-06-30(2 obs)

Value the bands apply to

26.7%as of 2026-06-30(2 obs)

102 observations. Hollow points are disputed (see counterevidence). Every point links to its observation.

Derived rows (88)

as of	value	inputs
2026-06-30	26.7%	obs:27f07ca3 obs:b4fc2fe6
2026-05-31	27.3%	obs:789cf849 obs:977a533c
2026-04-30	28.6%	obs:0e35d1d5 obs:50166b74
2026-03-31	29.2%	obs:3bd5e45f obs:a413fdf8
2026-02-28	28.2%	obs:617181da obs:fdf2a084
2026-01-31	29.5%	obs:1d6ff47d obs:acb092ca
2025-12-31	30.5%	obs:15d0a1df obs:e19700fe
2025-11-30	30.1%	obs:abfa3e8e obs:bca17f14
2025-10-31	30.6%	obs:535b9098 obs:84d04bdf
2025-09-30	31.1%	obs:2b205bef obs:967b681a
2025-08-31	30.4%	obs:19244a36 obs:ee99e6b5
2025-07-31	31.5%	obs:21394418 obs:598c6bc0
2025-06-30	30.7%	obs:27f07ca3 obs:5770dc35
2025-05-31	29.9%	obs:789cf849 obs:90f28e0f
2025-04-30	28.4%	obs:3f9af2a8 obs:50166b74
2025-03-31	29.0%	obs:3bd5e45f obs:5eac2f03
2025-01-31	27.5%	obs:1d6ff47d obs:a2aec37d
2024-12-31	27.2%	obs:15d0a1df obs:b8bf72db
2024-11-30	28.5%	obs:bca17f14 obs:bf71d97b
2024-10-31	29.1%	obs:535b9098 obs:b4b54cac
2024-09-30	30.8%	obs:967b681a obs:b5dae303
2024-08-31	32.6%	obs:d48a3197 obs:ee99e6b5
2024-07-31	31.0%	obs:2f6fdda7 obs:598c6bc0
2024-06-30	32.8%	obs:48c219f0 obs:5770dc35
2024-05-31	32.5%	obs:90f28e0f obs:bd3a1ae4
2024-04-30	32.7%	obs:3f9af2a8 obs:a6b158f8
2024-03-31	33.8%	obs:58b3d290 obs:5eac2f03
2024-02-29	35.7%	obs:6f8306ad obs:ef6a59c8
2024-01-31	37.3%	obs:a05be204 obs:a2aec37d
2023-12-31	35.5%	obs:060a9920 obs:b8bf72db
2023-11-30	33.4%	obs:71b548d8 obs:bf71d97b
2023-10-31	32.3%	obs:affb110c obs:b4b54cac
2023-09-30	30.3%	obs:2fa07de6 obs:b5dae303
2023-08-31	29.0%	obs:d48a3197 obs:debd7632
2023-07-31	30.1%	obs:2f6fdda7 obs:498dacc8
2023-06-30	30.8%	obs:48c219f0 obs:ff6a9b0a
2023-05-31	33.3%	obs:bd3a1ae4 obs:eb2b092c
2023-04-30	34.3%	obs:a6b158f8 obs:a83d656b
2023-03-31	34.4%	obs:58b3d290 obs:94969583
2023-02-28	32.5%	obs:5e9004cf obs:6f8306ad
2023-01-31	31.7%	obs:647ad4e4 obs:a05be204
2022-12-31	34.1%	obs:060a9920 obs:66fdb539
2022-11-30	36.2%	obs:51bd729d obs:71b548d8
2022-10-31	37.3%	obs:47c9c39e obs:affb110c
2022-09-30	37.3%	obs:2fa07de6 obs:49c5f6f6
2022-08-31	39.1%	obs:14036826 obs:debd7632
2022-07-31	39.3%	obs:498dacc8 obs:a5e8f5a8
2022-06-30	38.9%	obs:f4b76a50 obs:ff6a9b0a
2022-05-31	37.8%	obs:5ec33f3e obs:eb2b092c
2022-04-30	35.7%	obs:3211c7d0 obs:a83d656b
2022-03-31	35.0%	obs:35efd80a obs:94969583
2022-02-28	37.5%	obs:06326e91 obs:5e9004cf
2022-01-31	37.4%	obs:647ad4e4 obs:d82646c2
2021-12-31	37.3%	obs:66fdb539 obs:72ef5d6b
2021-11-30	36.0%	obs:303c5485 obs:51bd729d
2021-10-31	37.1%	obs:47c9c39e obs:910190d6
2021-09-30	39.0%	obs:1c9c08d3 obs:49c5f6f6
2021-08-31	40.5%	obs:14036826 obs:87df77cd
2021-07-31	41.4%	obs:9c414ece obs:a5e8f5a8
2021-06-30	43.3%	obs:273d4fc6 obs:f4b76a50
2021-05-31	44.9%	obs:25a9b168 obs:5ec33f3e
2021-04-30	45.7%	obs:3211c7d0 obs:5885002f
2021-03-31	43.9%	obs:35efd80a obs:60b5bc03
2021-01-31	49.6%	obs:d82646c2 obs:fde47a75
2020-12-31	49.1%	obs:72ef5d6b obs:99ff792f
2020-11-30	52.7%	obs:303c5485 obs:7c34c2eb
2020-10-31	55.9%	obs:910190d6 obs:d151cd73
2020-09-30	54.4%	obs:1c9c08d3 obs:d7f3e8ac
2020-08-31	52.8%	obs:87df77cd obs:ed2ed0cc
2020-07-31	53.6%	obs:9c414ece obs:f3a06d7e
2020-06-30	55.8%	obs:273d4fc6 obs:8b06bef5
2020-05-31	55.4%	obs:25a9b168 obs:f638cfab
2020-04-30	58.0%	obs:5885002f obs:d512c298
2020-03-31	60.7%	obs:4af397cc obs:60b5bc03
2020-02-29	57.0%	obs:59597bcf obs:a0c7669c
2020-01-31	53.5%	obs:6f68dce3 obs:fde47a75
2019-12-31	52.6%	obs:99ff792f obs:f50dc438
2019-11-30	58.6%	obs:3dd80d51 obs:7c34c2eb
2019-10-31	62.3%	obs:24f326c9 obs:d151cd73
2019-09-30	64.8%	obs:12aa72f3 obs:d7f3e8ac
2019-08-31	63.1%	obs:2f31d4ed obs:ed2ed0cc
2019-07-31	61.3%	obs:58011020 obs:f3a06d7e
2019-06-30	57.4%	obs:549b91a8 obs:8b06bef5
2019-05-31	60.6%	obs:06d04cb0 obs:f638cfab
2019-04-30	64.1%	obs:43241d3d obs:d512c298
2019-03-31	64.6%	obs:4af397cc obs:b693982d
2019-02-28	66.3%	obs:350a5721 obs:59597bcf
2019-01-31	68.5%	obs:6f68dce3 obs:efb251b2

5Status and reasoning

consistent with normalsince 2026-09-10 · evaluate

Evaluator: 26.69 (FDA AI-enabled medical device list, 2026-06-30) is inside the consistent band (hi=50). Auto-reason; band rationale: Normal = the cumulative count growing under 50% a year (the 2019-2024 pace); fast = doubling or faster, which is what an ungated regulated domain would show. Between is emerging.

6Timeline notes

2026-06-30 · 26.7%as of 2026-06-30(2 obs)
2026-05-31 · 27.3%as of 2026-05-31(2 obs)
2026-04-30 · 28.6%as of 2026-04-30(2 obs)
2026-03-31 · 29.2%as of 2026-03-31(2 obs)
2026-02-28 · 28.2%as of 2026-02-28(2 obs)
2026-01-31 · 29.5%as of 2026-01-31(2 obs)

7Counterevidence

What cuts against this reading

The list is updated in batches and reclassified; a cleared device is not a deployed one; LLM-based devices are a handful at most.

8Update history

2026-09-10unmeasured to consistent with normalconf — → 70 · evaluate
Evaluator: 26.69 (FDA AI-enabled medical device list, 2026-06-30) is inside the consistent band (hi=50). Auto-reason; band rationale: Normal = the cumulative count growing under 50% a year (the 2019-2024 pace); fast = doubling or faster, which is what an ungated regulated domain would show. Between is emerging.
obs:27f07ca3 obs:b4fc2fe6

9Confidence

70 / 95 — good evidence, some ambiguity

Confidence is independent of status: 90–95 multiple strong independent sources; 70–89 good evidence, some ambiguity; 50–69 mixed or hard to operationalise; below 50 limited or vague.

10Related

Safety brakes inside the labs (events, trailing year) emerging
US state AI bills introduced (legislative year) emerging