ArticleAI/ML
How TEMPO and ACCESS Could Support Wearable Diagnostic AI
Most diagnostic AI teams clear FDA, then stall on reimbursement. FDA's TEMPO pilot and CMS's ACCESS model take on evidence and ...
J. David Giese
PARTNER
Joined: January 1, 2012
I help bring high-impact diagnostic medical devices onto the US market. I’ve helped develop over 40 diagnostic devices since 2012. I provide a pragmatic, cross-functional perspective, with a background in biomedical engineering, software development, and FDA regulatory consulting. I run Innolitics with Yujan, my old friend and business partner.
I enjoy reading, thinking, and writing about classic literature, philosophy, history, and religion. My personal website is goodlifeodyssey.com.
ArticleAI/ML
Most diagnostic AI teams clear FDA, then stall on reimbursement. FDA's TEMPO pilot and CMS's ACCESS model take on evidence and ...
J. David Giese
ArticleRegulatory
A Pre-Sub is a mechanism for requesting formal written feedback from the FDA, and (optionally) a one-hour meeting. Pre-subs are...
J. David Giese
ArticleRegulatory
The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inpu...
J. David Giese
ArticleRegulatory
A concise guide to the FDA’s De Novo pathway for novel, moderate-risk medical devices that lack a suitable predicate. It includ...
J. David Giese
ArticleCybersecurity
This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. ...
J. David Giese &
ArticleCybersecurity
Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerab...
J. David Giese
ArticleRegulatory
A comprehensive FAQ for people who are interested in creating a new medical device software to learn the basics about the US re...
J. David Giese
ArticleAI/ML
FDA has selected Cadence as the second participant in TEMPO. Its clinician-supervised HypertensionOS software generates protoco...
J. David Giese
ArticleAI/ML
With predetermined change control plans (PCCPs), FDA has given manufacturers a great new regulatory tool. In this article, we d...
J. David Giese
ArticleSoftware
Notes on medtech funding, covering accelerators and funding sources.
J. David Giese
