March 12, 2026
The FDA held a virtual town hall on March 11th, 2026 on the Clinical Decision Support (CDS) Software guidance update, which published on January 6th, 2026 and republished on January 29, 2026. This was an eagerly awaited event to…Read More
February 12, 2026
The FDA held a virtual town hall today (February 11th, 2026) on the General Wellness guidance update which published on January 6th, 2026. This was a highly anticipated event to address questions on the guidance, which was reported…Read More
January 7, 2026
The FDA released an update to the Clinical Decision Support Software (CDS software) guidance yesterday (January 6, 2026) in what was a surprise move to virtually all in the FDA regulatory space. To put some historical context on…Read More
January 6, 2026
The FDA released a final guidance update to the General Wellness: Policy for Low Risk Devices today (January 6, 2026) in what could only be characterized as a sudden and momentous event. It is worth noting that this…Read More
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
