We write medical device software.
Joined March 2015
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42 Photos and videos
12 Dec 2024
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
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6 Dec 2024
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!
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5 Dec 2024
What a wonderful end to #RSNA24
Special thanks to our team who helped make this conference a success 😊
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3 Dec 2024
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.
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2 Dec 2024
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.
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17 Nov 2024
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.
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16 Nov 2024
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 :).
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7 Nov 2024
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.
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6 Nov 2024
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
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4 Nov 2024
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)
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4 Nov 2024
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.
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29 Oct 2024
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.
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14 Oct 2024
Ready to rock!
Come see us at The MedTech Conference this week at Booth #1017
#medicaldevices #fda #medtech
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10 Oct 2024
Come visit us at MedTech Conference in Toronto next week!
Book a meeting to reserve your spot in advance:
hubs.li/Q02SYW7F0
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5 Oct 2024
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
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30 Sep 2024
We are at the cusp of an explosion of AI powered medical devices.
Let us know your thoughts ⤵️
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22 Sep 2024
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
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