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.
August 12, 2025
Illumina is paying about $10 million because they sold FDA regulated products to the US Government that weren’t meeting FDA cybersecurity requirements for a regulated device, not for an actual cybersecurity breach. One has to wonder what other…Read More
August 11, 2025
The Illinois Governor signed into law last week The Wellness and Oversight for Psychological Resources Act which prohibits the use of AI to provide mental health and therapeutic decision-making, but allows the use of AI for administrative and…Read More
Artera received a FDA Breakthrough Designation for AI prostate test (an AI-enabled tool designed to assist clinicians in making risk-based decisions for patients with localized prostate cancer). Artera’s Breakthrough designation for ArteraAI Prostate was announced July 9th is…Read More
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
