Day: August 15, 2024

The Centers for Medicare & Medicaid Services (CMS) announced a new program to provide coverage to medical devices approved under the Breakthrough Device program. Most breakthrough devices are approved with limited safety and efficacy data and it would be hard to secure coverage under the conventional review process. The new program is designed to address … Read more

In the last 10 years, the FDA has approved about a thousand medical devices containing Artificial Intelligence/Machine Learning (AI/ML) algorithms. Although the devices cover diverse indications and types, there are some interesting regulatory trends to be considered for those developing a new AI/ML device.  The number of AI/ML devices approved by the FDA has steadily … Read more