May 20, 2024
Based on this groundbreaking de novo classification granted last month to Prenosis, the flag is up that any player in the AI scanning of electronic health records (EHR) space with the intent to predict, diagnose and/or risk stratify…Read More
February 22, 2024
The FDA has been busy recently in sending out public notices about bad actors in the medical device space. Though no companies are named specifically here, certain sellers of smartwatches and smart rings apparently claim their devices measure…Read More
No bad actor third party testing laboratories were specifically named in this article (other than being entities based in China and India), but it boggles the mind that a third party testing lab would generate “testing data that…Read More
November 4, 2023
FDA recently issued a warning letter to Wavi that claimed its AI code used for its Wavi Desktop product was “for research use only” and not subject to FDA regulation. This is not a judgement on Wavi as…Read More
October 19, 2023
It is encouraging to see the FDA’s Center for Devices and Radiological Health (CDRH) has signaled in their proposed guidances for fiscal year 2024 (FY2024) that guidances related to Artificial Intelligence/Machine Learning (AI/ML) are getting a high priority…Read More
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
