Year in review

FDA AI medical device clearances in 2018

2018 has 65 AI devices, 140.7% more than 2017 (27). They come from 62 companies. Radiology accounted for 40 (61.5%). The newest decision was AmCAD-UO from AmCad BioMed Corporation on December 28, 2018.

65Decisions in 2018
62Companies
61.5%Share in Radiology
53First-time companies

By specialty

Top companies

Decisions by month

Jan: 5Feb: 3Mar: 4Apr: 4May: 6Jun: 6Jul: 4Aug: 3Sep: 3Oct: 5Nov: 10Dec: 12
JanFebMarAprMayJunJulAugSepOctNovDec
FDA AI device decisions by month in 2018: Jan 5, Feb 3, Mar 4, Apr 4, May 6, Jun 6, Jul 4, Aug 3, Sep 3, Oct 5, Nov 10, Dec 12

Pathways

510(k): 58 (89.2%) · De Novo: 7 (10.8%). The first decision in 2018 was WAVE Clinical Platform (January 4, 2018).

Companies with a first AI clearance in 2018

53 companies have their earliest device on this list dated 2018. The busiest of those first-timers is GE Medical Systems Ultrasound and Primary Care Diagnostics, with 2 decisions in 2018. Showing 8 of 53.

GE Medical Systems Ultrasound and Primary Care Diagnostics2Agfa HealthCare N.V.1Aidoc Medical, Ltd.1AIQ Solutions, Inc.1AMRA Medical AB1Athelas, Inc.1Bay Labs, Inc.1Bonraybio Co., LTD.1

Newest decisions in 2018

The full 2018 set is split by specialty above. Radiology in 2018 · Cardiovascular in 2018 · Neurology in 2018

201980201727All yearsStatistics

Frequently asked questions

How many AI medical devices did the FDA authorize in 2018?

The FDA list has 65 AI-enabled devices with a final decision dated 2018, from 62 companies.

Which specialty had the most AI clearances in 2018?

Radiology led with 40 devices, 61.5% of 2018.

Which company had the most FDA AI devices in 2018?

Arterys, Inc. had the most, with 2. Next: GE Medical Systems Ultrasound and Primary Care Diagnostics (2), Quantib B.V. (2).

How did 2018 compare with 2017?

2018 has 65 AI devices, 140.7% more than 2017 (27).

How many companies received their first AI-device decision in 2018?

53 companies have their earliest AI-device decision dated 2018.

Cite as: AI Device Radar, “FDA AI medical device clearances in 2018,” https://ai-device-radar.vercel.app/year/2018 (FDA list through 2026-06-29).