Year in review

FDA AI medical device clearances in 2016

2016 has 18 AI devices, 200% more than 2015 (6). They come from 17 companies. Radiology accounted for 11 (61.1%). The newest decision was ClearView cCAD from ClearView Diagnostics Inc. on December 28, 2016.

18Decisions in 2016
17Companies
61.1%Share in Radiology
16First-time companies

By specialty

Top companies

Decisions by month

Jan: 2Feb: 0Mar: 0Apr: 0May: 0Jun: 1Jul: 3Aug: 3Sep: 3Oct: 1Nov: 3Dec: 2
JanFebMarAprMayJunJulAugSepOctNovDec
FDA AI device decisions by month in 2016: Jan 2, Feb 0, Mar 0, Apr 0, May 0, Jun 1, Jul 3, Aug 3, Sep 3, Oct 1, Nov 3, Dec 2

Pathways

510(k): 17 (94.4%) · PMA: 1 (5.6%). The first decision in 2016 was Volpara Imaging Software (January 7, 2016).

Companies with a first AI clearance in 2016

16 companies have their earliest device on this list dated 2016. The busiest of those first-timers is HeartFlow, Inc., with 2 decisions in 2016. Showing 8 of 16.

HeartFlow, Inc.2AgaMatrix, Inc.1ALGOMEDICA1Clarius Mobile Health Corp.1ClearView Diagnostics Inc.1Cydar Ltd.1DIACARDIO, LTD.1GAUSS SURGICAL INC.1

All 18 decisions

201727All yearsStatistics

Frequently asked questions

How many AI medical devices did the FDA authorize in 2016?

The FDA list has 18 AI-enabled devices with a final decision dated 2016, from 17 companies.

Which specialty had the most AI clearances in 2016?

Radiology led with 11 devices, 61.1% of 2016.

Which company had the most FDA AI devices in 2016?

HeartFlow, Inc. had the most, with 2. Next: AgaMatrix, Inc. (1), ALGOMEDICA (1).

How did 2016 compare with 2015?

2016 has 18 AI devices, 200% more than 2015 (6).

How many companies received their first AI-device decision in 2016?

16 companies have their earliest AI-device decision dated 2016.

Cite as: AI Device Radar, “FDA AI medical device clearances in 2016,” https://ai-device-radar.vercel.app/year/2016 (FDA list through 2026-06-29).