Industry News


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Transparency in Reporting

The FDA system of reporting has become more transparent recently. With that transparency the FDA has released over 20 years of records on medical device adverse events. FDA is working to update its Medical Device Reporting program, one of the tools they use to continue to ensure safety in the landscape of health care.

 
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Black-Box Algorithms

This black box algorithm is the the latest road map to a blend of medicine and computers. What are the pitfalls and what are the benefits? How much real clinical knowledge is needed until this technology becomes feasible?

 
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FDA Revamps Process

“We’re seizing the chance to make a generational change in the framework for 510(k) reviews–one that advances its best features while making sure it keeps pace with modern innovation,” states the Agency as it launches new goals to drive sponsors to offer devices with the latest improvement and advances.

 
 
 
 

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Visit Agilis at RAPS

Register now to attend this years RAPS Convergence. We want to meet you, so please reach out and lets schedule a face to face. This year we are presenting an exciting topic that you will not want to miss.

Email: kbreunig@agilisconsulting.com