article thumbnail

Commercial AI devices lack clinical validation, study finds

AuntMinnie

Commercial AI devices that lack adequate clinical validation may pose risks for patient care – and unfortunately, that’s true for almost half of the tools cleared so far by the U.S. Most notably, 226 of 521 (43%) lacked published clinical validation data.

Clinic 64
article thumbnail

Positron Corporation Announces Start of Clinical Study of Affinity PET-CT Device

Imaging Technology

milla1cf Fri, 09/08/2023 - 16:25 September 8, 2023 — Positron Corporation , a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA. on September 18, 2023.

Clinic 105
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

FDA analysis affirms use of computational models in imaging trials

AuntMinnie

In silico imaging trials represent a viable source of regulatory evidence for imaging device evaluation, according to an analysis conducted by the U.S. Food and Drug Administration (FDA) and published August 9 in Plos Computational Biology. Read the full paper here.

article thumbnail

Philips Spotlights Scalable and Interoperable Clinical and Operational Solutions at #HIMSS24

Imaging Technology

milla1cf Fri, 03/15/2024 - 16:41 March 15, 2024 — Visitors to the Philips Booth at HIMSS in Orlando, Fla, experienced smart, scalable and sustainable clinical solutions designed to help accelerate speed to diagnosis and treatment while improving operational efficiencies, patient outcomes, health equity, and staff experience.

Clinic 52
article thumbnail

Hyperfine Announces FDA Clearance of Software Update That Enables Faster Acquisition of Best-in-Class Ultra-Low-Field Brain Images

Imaging Technology

mtaschetta-millane Wed, 07/17/2024 - 10:52 July 17, 2024 — Hyperfine , a groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop system—announced the clearance of the ninth generation of AI-powered Swoop system software.

article thumbnail

How imaging AI developers can avoid pitfalls when testing algorithms

AuntMinnie

Researchers led by Seyed Tabatabaei, MD, from Massachusetts General Hospital and Harvard Medical School in Boston, in their clinical perspective outlined these pitfalls and made suggestions on AI model training and validation, as well as using diverse datasets.

Imaging 105
article thumbnail

Philips Announces New Interoperability Capabilities That Offer a Comprehensive View of Patient Health for Improved Monitoring and Care Coordination

Imaging Technology

As a world leader monitoring more than 600 million patients each year worldwide, Philips is creating an open patient monitoring ecosystem to bring together disparate medical devices and systems on a single interface. Every day, clinicians make countless care decisions based on information from divided medical devices and systems.