Newsletter - August 15, 2024
Trends from FDA-Approved AI/ML Devices
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...Read More
CMS Reimbursement for Breakthrough Medical Devices
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...Read More
Trends from FDA-Approved AI/ML Devices
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...Read More
CMS Reimbursement for Breakthrough Medical Devices
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...Read More
