Overview

As the healthcare industry continues to transform through innovative technologies in the Artificial Intelligence space, the U.S. Food and Drug Administration (FDA) has taken further action to effectively regulate these devices. They have released an Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD) Action Plan outlining the discussion and requesting feedback. To review the plan and provide feedback, click on the article above.

How can Stat One help?

Stat One has helped many Artificial Intelligence (AI) clients get their products analyzed and approved by the FDA.  Our team takes a focused approach based on FDA guidance for AI-related products.  Utilizing our statistical expertise and industry knowledge, we can provide assistance for items such as:

• Study Design
• Sample Size Calculation
• Statistical Analyses
• Participation in FDA Discussions

To learn more about Stat One’s experience, view our Artificial Intelligence (AI) brochure. Stat One is a specialty CRO with over 25 years of experience supporting clinical trials for pharmaceutical, biotechnology, and medical device companies. We also provide eClinical solutions to our clients.  Our industry knowledge of over two decades combined with our focus on quality makes us an excellent choice for your partner in growing a better future.  Our strong background in clinical trials along with our user-friendly technology helps our clients make the most of their time and budget. Stat One works with you to achieve your goals. If you would like to speak with Stat One about how we can assist with FDA guidance and device development, please contact us at https://www.statonellc.com/contact/.