Medical Device Network

GE HealthCare tops FDA’s AI-enabled medical device authorisation list

The FDA recently updated its AI/ML-enabled device list with new additions, and radiology continues to dominate.

GE HealthCare is at the forefront of the artificial intelligence (AI) wave sweeping through the medical device industry, according to a recently updated US Food and Drug Administration (FDA) list of AI-enabled medical device clearances and authorisations.

The FDA recently updated its list of AI/machine learning (ML)-enabled devices to include 171 new devices, the majority of which had decision dates between August 2022 and July 2023.

GE HealthCare has 58 devices that either have 510(k) clearances or authorisations on the list. The company took the top spot, which it also occupied during the previous update of the list in 2022.

The FDA said that it expects the year-over-year increase of AI/ML-enabled devices in 2023 to exceed 30%. This is up from 15% in 2021 and 14% in 2022, where submissions slowed.

A 2023 report by GlobalData predicts that global revenue for AI platforms across healthcare will reach $18.8bn by 2027.

This month, the FDA established a new advisory committee to understand the benefits and risks of using technologies such as AI and ML.

AI/ML devices in radiology dominated the list, accounting for 79% of devices authorised through the end of July 2023. The FDA added that radiology has the steadiest increase of AI/ML-enabled device submissions compared to other specialities.

In October 2023, GE HealthCare signed a $44m deal with the Biomedical Advanced Research and Development Authority (BARDA) to develop AI-enabled ultrasound technology. In the same month, the company also had its AI-driven Venue ultrasound systems cleared by the FDA.

Whilst AI’s future in radiology is bright, some in the industry have highlighted the importance of accelerating wider digital infrastructure in parallel to implementing AI.

Despite the bounce back of AI/ML-enabled medical device submissions and the proliferation of technology such as ChatGPT, the FDA was keen to highlight that no devices that use generative AI or large language models have been authorised.

GE HealthCare’s chief technology officer Dr Taha Kass-Hout said in a statement: “We are still in the nascent stages of AI development, and its potential to redefine healthcare is immense. From bedside predictions, patient monitoring, and early diagnosis, to guided screening, AI's potential for contributions to customisation, precision, cost-saving, access, and health equity is unparalleled.