Innolitics

We are live. Join us for a cup of coffee and an interesting conversation about RSNA 2024 + free SaMD AI/ML Tips :) hubs.li/Q02_qsR90

I can't wait to try OpenAI o1 (full version)! It is also interesting OpenAI is granting some free licenses to medical researchers specifically. So far the reception appears promising!

What a wonderful end to #RSNA24 Special thanks to our team who helped make this conference a success 😊

Delicious end to #RSNA2024 Day 3 One more to go!

FDA just issued the final PCCP for AI Guidance! Here’s the link: hubs.li/Q02-7-WP0

We’re excited for day three of RSNA! We’ve already talked to dozens of companies at our booth—big and small—about their problems bringing radiology AI and software onto the US market. I’m always inspired by the grit of many of these talented people.

What a wonderful day 1 at #RSNA !!! Met a lot of new faces. And a lot of familiar faces. And a lot of LinkedIn faces that I can attach a 3D model to. And a lot of LinkedIn faces that are a lot taller in person than I had anticipated. See you at day 2.

Ready to rock at RSNA! Come visit us near the AI Theater. #RSNA

Is all synthetic data created by generative AI? In the strictest sense. Yes. But FDA introduces a bit of nuance: Knowledge based methods are hand crafted algorithms to create synthetic data. Generative methods are more black box but are a lot more realistic.

Wow! FDA has done their homework on synthetic data generation for medical devices. GANs, Diffusion based, Finite element analysis, Autoencoders, VAEs. This is a nice inventory of papers you can use to justify your future FDA application using synthetic data... from FDA :).

Investor: "Let's include Gen-AI to increase our valuation" Engineer: "Yes! It will be fun" DON'T. READ THIS FIRST. FDA says: If it can be done without Gen-AI, then do it without Gen-AI. FDA strategy is opposite to SBIR strategy. Novelty is not an asset—it is a risk.

We had mentioned during a weekly coffee QA chat that we have yet to clear an algorithm using continuous learning. Turns out FDA has not either :) Let's change that. Comment below if you have one. #fda #ai #medicaldevices

Will FDA regulate your Gen-AI enabled device? There are three options: 1. It is not a device (e.g. educational tools, admin, general wellness) 2. It may be a device but FDA won't regulate (e.g. "simple tasks") 3. It is a device and FDA intents to regulate (everything else)

Got a Gen-AI enabled med device that diagnoses across broad areas of medicine? Make sure your marketing and regulatory teams are talking. FDA thinks this will create the need for new types of scientific evidence for premarket evaluation. This likely means a De Novo or PMA.

Be sure to describe your dataset provenance for an FDA submission. I like to use visuals, tables, etc like the one shown here. If FDA can't find the information they are looking for in 10 minutes, they will probably bounce it right back to you.

Ready to rock! Come see us at The MedTech Conference this week at Booth #1017 #medicaldevices #fda #medtech

Come visit us at MedTech Conference in Toronto next week! Book a meeting to reserve your spot in advance: hubs.li/Q02SYW7F0

We can now submit small business determinations (SBD) electronically! Why do you need one? You need to file the SBD to qualify for the cheaper small business 510(k) review fee. Standard (non-small business) fee: $24,335 Small business fee: $6,084

We are at the cusp of an explosion of AI powered medical devices. Let us know your thoughts ⤵️

Here is my take on the Apple Sleep Apnea Notification Feature FDA study. Why did they design the study the way they did? What is the mechanism of action of the device? #samd #fda #applewatch #aimd