Year in review

FDA AI medical device clearances in 2017

2017 has 27 AI devices, 50% more than 2016 (18). They come from 26 companies. Radiology accounted for 16 (59.3%). The newest decision was Radiomics App v1.0 from Microsoft Corp. on December 27, 2017.

27Decisions in 2017
26Companies
59.3%Share in Radiology
21First-time companies

By specialty

Top companies

Decisions by month

Jan: 2Feb: 2Mar: 1Apr: 2May: 3Jun: 4Jul: 1Aug: 3Sep: 4Oct: 2Nov: 1Dec: 2
JanFebMarAprMayJunJulAugSepOctNovDec
FDA AI device decisions by month in 2017: Jan 2, Feb 2, Mar 1, Apr 2, May 3, Jun 4, Jul 1, Aug 3, Sep 4, Oct 2, Nov 1, Dec 2

Pathways

510(k): 23 (85.2%) · De Novo: 2 (7.4%) · PMA: 2 (7.4%). The first decision in 2017 was Arterys Cardio DL (January 5, 2017).

Companies with a first AI clearance in 2017

21 companies have their earliest device on this list dated 2017. The busiest of those first-timers is ImpediMed Limited, with 2 decisions in 2017. Showing 8 of 21.

ImpediMed Limited223andMe, Inc.1AmCad BioMed Corporation1Arterys, Inc.1Body Vision Medical Ltd.1Cardiologs Technologies1Cella Vision AB1CorTechs Labs, Inc.1

All 27 decisions

201865201618All yearsStatistics

Frequently asked questions

How many AI medical devices did the FDA authorize in 2017?

The FDA list has 27 AI-enabled devices with a final decision dated 2017, from 26 companies.

Which specialty had the most AI clearances in 2017?

Radiology led with 16 devices, 59.3% of 2017.

Which company had the most FDA AI devices in 2017?

ImpediMed Limited had the most, with 2. Next: 23andMe, Inc. (1), AmCad BioMed Corporation (1).

How did 2017 compare with 2016?

2017 has 27 AI devices, 50% more than 2016 (18).

How many companies received their first AI-device decision in 2017?

21 companies have their earliest AI-device decision dated 2017.

Cite as: AI Device Radar, “FDA AI medical device clearances in 2017,” https://ai-device-radar.vercel.app/year/2017 (FDA list through 2026-06-29).