The arena of digital health and FDA regulations that apply to apps, wearables and software, including artificial intelligence (AI) and machine learning (ML) continue to evolve in the United States. See select articles and tweets for latest news one these topics here.
October 6, 2023
As a follow-up to the late breaking news article on September 29, 2023 regarding FDA’s issuance of a proposed rule to regulated laboratory developed test (LDTs), multiple stake holders, such as the American Clinical Laboratories Association (ACLA) and…Read More
September 29, 2023
It has been highly anticipated that FDA was planning to issue a new proposed rule on laboratory developed tests (LDTs) with suggestions that a proposed rule could come in by the end of this week. The expectation clearly…Read More
September 28, 2023
In March 2023, the FDA released a final guidance titled “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency“, which at high level set out a timeline…Read More
September 22, 2023
On September 6th, 2023, the FDA released three draft guidances with the stated of goal of “…Part of Ongoing Efforts to Modernize the Premarket Notification [510(k)] Program”. I can not encourage industry and regulatory professionals enough to review…Read More
August 24, 2023
Two devices with recent De Novo Classifications were reported on recently in the Viz.ai HCM and Better Therapeutics devices that employ Artificial Intelligence (AI) and/or Machine Learning (ML). The Classification Order for both were recently published and present…Read More
August 17, 2023
It is not often the FDA offers truly transformative guidance to enable industry to constructively advance cutting edge technology in a practical way. But with the draft FDA guidance titled “Marketing Submission Recommendations for a Predetermined Change Control…Read More
August 8, 2023
Medical device makers have seen a productive summer with warm receptions at FDA for Artificial intelligence (AI) enabled devices. Over the last five weeks, a number of De Novo classifications and 510(k) clearances granted by FDA cover a…Read More
September 13, 2018
Apple made a number of high profile announcements yesterday regarding their new iPhone releases, but of particular interest to the medical device world was the Apple Watch Series 4 product announcement by the Verge on the incorporation of…Read More
January 21, 2018
Honda announced this week that they received a Medical Devices Directive (Council Directive 93/42/EEC) certification for their Honda Walking Assist Device, an assistive device for use in the training and rehabilitation of walking, which allows Honda to affix…Read More
March 8, 2016
IBM (NYSE: IBM) announced last month that Watson Health will gain the ability to analyze the cost and treatment data on more than 200 million patients with the $2.6 Billion purchase of Truven Health Analytics. This comprised the fourth…Read More
