PARTNER
Joined: January 1, 2012
I have led or supported FDA submissions for 40+ diagnostic devices since 2012, across 510(k), De Novo, Q-Sub, and PCCP, including cleared 510(k)s for Echo IQ and Prenuvo. I co-founded Innolitics in 2012 and was the named FDA contact on Echo IQ's EchoSolv AS (K241245, 2024) and Prenuvo Body Composition (K242825, 2025); in 2026 I helped GuideAI Health clear a vascular occlusion triage CADt 510(k) without a pre-submission. My work spans radiology AI (CADt, CADe, CADx, quantitative imaging), ECG and signal analysis software, and SaMD cybersecurity across 65 Innolitics projects, and I write our long-form guides on FDA software regulation, cybersecurity, SBOMs, pre-subs, PCCPs, and De Novo requests. I hold biomedical engineering degrees from Boston University (M.S.) and UT Austin (B.S.) and run Innolitics with Yujan, my old friend and business partner.
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.
ArticleRegulatory
A concise guide to the FDA’s De Novo pathway for novel, moderate-risk medical devices that lack a suitable predicate. It includes real-world examples and offers insider tips on ...
J. David Giese
ArticleAI/ML
FDA selected Limbic’s agentic therapy device for the TEMPO pilot. Its public evidence offers a rare look at layered AI architecture, prospective clinical testing, post-market mo...
J. David Giese
ArticleCybersecurity
This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. It also includes examples and resources for those ...
J. David Giese
ArticleRegulatory
The question we hear most from AI-SaMD teams. How FDA's device definition and the five statutory carve-outs actually apply, why the call is harder than it looks, why competitors...
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 a useful means to mitigate regulatory risk. This ...
J. David Giese
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 payment together. Here's how the two work, and wha...
J. David Giese
ArticleRegulatory
The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article presents Innolitics’...
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 includes real-world examples and offers insider tips on ...
J. David Giese
ArticleCybersecurity
Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerabilities.
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 regulations.
J. David Giese
