Year in review

FDA AI medical device clearances in 2019

2019 has 80 AI devices, 23.1% more than 2018 (65). They come from 65 companies. Radiology accounted for 51 (63.8%). The newest decision was BriefCase from Aidoc Medical, Ltd. on December 20, 2019.

80Decisions in 2019
65Companies
63.8%Share in Radiology
44First-time companies

By specialty

Top companies

Decisions by month

Jan: 3Feb: 3Mar: 5Apr: 6May: 6Jun: 6Jul: 11Aug: 7Sep: 7Oct: 5Nov: 11Dec: 10
JanFebMarAprMayJunJulAugSepOctNovDec
FDA AI device decisions by month in 2019: Jan 3, Feb 3, Mar 5, Apr 6, May 6, Jun 6, Jul 11, Aug 7, Sep 7, Oct 5, Nov 11, Dec 10

Pathways

510(k): 80 (100%). The first decision in 2019 was MRCP+ v1.0 (January 9, 2019).

Companies with a first AI clearance in 2019

44 companies have their earliest device on this list dated 2019. The busiest of those first-timers is Ge Medical Systems, LLC, with 3 decisions in 2019. Showing 8 of 44.

Ge Medical Systems, LLC3Biofourmis Singapore Pte. Ltd2Canon Medical Systems Corporation2Perspectum Diagnostics Ltd2RaySearch Laboratories AB (PUBL)23D Systems, Inc.17D Surgical Inc.1AliveCor, Inc.1

Newest decisions in 2019

The full 2019 set is split by specialty above. Radiology in 2019 · Cardiovascular in 2019 · Neurology in 2019

2020114201865All yearsStatistics

Frequently asked questions

How many AI medical devices did the FDA authorize in 2019?

The FDA list has 80 AI-enabled devices with a final decision dated 2019, from 65 companies.

Which specialty had the most AI clearances in 2019?

Radiology led with 51 devices, 63.8% of 2019.

Which company had the most FDA AI devices in 2019?

Siemens Medical Solutions USA, Inc. had the most, with 5. Next: Aidoc Medical, Ltd. (3), Ge Medical Systems, LLC (3).

How did 2019 compare with 2018?

2019 has 80 AI devices, 23.1% more than 2018 (65).

How many companies received their first AI-device decision in 2019?

44 companies have their earliest AI-device decision dated 2019.

Cite as: AI Device Radar, “FDA AI medical device clearances in 2019,” https://ai-device-radar.vercel.app/year/2019 (FDA list through 2026-06-29).