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.
December 18, 2025
There was recent news for the possible relaxation of rules for MDR with respect to medical device software (MDSW), including for MDSW utilizing artificial intelligence (AI). The December 16, 2025 proposed amendment to classification rules for MDSW for…Read More
December 9, 2025
The comment period for the CDRH fiscal year 2026 (FY 2026) proposed guidance development closed on December 1, 2026 and it was reported recently in RAPS that certain industry participants officially asked both for withdrawal of certain guidances…Read More
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
