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Health Tech Pulse
FDA's AI-enabled medical devices over time and the newest additions, novel drug approvals including GLP-1 and obesity drugs, and what pharmacies pay for GLP-1 pens. Curious Minds go Deeper.
Questions this answers
- How fast is FDA authorizing AI medical devices?
- Which specialties use the most AI?
- Is FDA approving more new drugs this year?
- What do pharmacies pay for Wegovy, Ozempic, Zepbound and Mounjaro?
Free public data: FDA, CMS
Informational only, not medical, financial or legal advice. Talk with a licensed clinician about any drug or device. Data comes from the cited public sources and can lag or be revised. Not affiliated with FDA, CMS or any drug or device maker. Views are Martin's own, not Adobe's.
FDA AI-enabled medical devices authorized per year
Latest additions
Each submission number links to its FDA database record. Source: FDA Artificial Intelligence-Enabled Medical Devices list.
By specialty and pathway
FDA novel drug approvals (CDER)
Approvals list
Approved use is FDA's own wording on the approval date. Source: FDA Novel Drug Approvals. Biologics approved by CBER, such as vaccines and gene therapies, are not included.
Diabetes, obesity and metabolic novel approvals
Flagged by keyword in the active ingredient or FDA approved-use text (obesity, weight, diabetes, glycemic, insulin, GLP-1 and known incretin ingredients). New uses of existing drugs, such as Zepbound for weight in 2023, are not novel approvals and do not appear here. Source: FDA Novel Drug Approvals, 2021 on.
What pharmacies pay for GLP-1 pens (NADAC)
NADAC is the National Average Drug Acquisition Cost: a weekly CMS survey of what retail pharmacies pay to buy a drug. It is not the patient price, list price or what insurance pays. Four weeks equals four single-dose pens, or one multi-dose pen that holds four weekly doses. Source: CMS NADAC on data.medicaid.gov.
Method
Sources
- FDA Artificial Intelligence-Enabled Medical Devices list (CSV download, updated periodically by FDA).
- FDA CDER Novel Drug Approvals, yearly pages 2021 on.
- CMS NADAC (National Average Drug Acquisition Cost), weekly, via the data.medicaid.gov API.
- Checked, not used: retail cash prices from discount card sites are not a free public dataset with clear reuse terms. No paid data.
Built by Martin Goetzinger, Enterprise Account Executive. Figures are computed from the cited sources at build time. Not medical advice.
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Read https://www.martingoetzinger.com/pages/health-tech-pulse and summarize how fast FDA is authorizing AI-enabled medical devices, which specialties lead, how this year's novel drug approvals compare with last year, and what NADAC shows for GLP-1 pens. Do not give medical advice. My interest: [specialty or drug].
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Go deeper on Health Tech Pulse
Quizzes, guides and answers built to go with this calculator.
5 Guides
Read the guides
- AI in Healthcare: Why It Moves Fastest
- FDA AI-Enabled Medical Devices
- FDA Novel Drug Approvals
- CMS NADAC dataset
FAQs
5 common questions, answered
- Is this medical advice?
- What counts as an AI-enabled device?
- Why do Wegovy and Zepbound not show as novel approvals?
Learn
Articles 5
- AI in Healthcare: Why It Moves FastestWhy healthcare is adopting AI faster than other industries.
- FDA AI-Enabled Medical DevicesThe official list behind the device counts.
- FDA Novel Drug ApprovalsEvery new molecule CDER approves, by year.
- CMS NADAC datasetThe weekly pharmacy acquisition cost data, free to download.
- FDA on unapproved GLP-1 drugsFDA safety concerns about compounded and unapproved versions.
Frequently asked questions
Is this medical advice?
No. This page summarizes public FDA and CMS data for education. Talk with a licensed clinician about any treatment, device or drug.
What counts as an AI-enabled device?
FDA keeps a list of devices it has authorized that use artificial intelligence or machine learning. FDA notes the list is not exhaustive and is updated periodically, so recent authorizations can take months to appear.
Why do Wegovy and Zepbound not show as novel approvals?
Novel approvals are new molecules. Wegovy uses semaglutide (first approved as Ozempic) and Zepbound uses tirzepatide (first approved as Mounjaro), so they were new uses and brands, not novel drugs.
Is NADAC what I will pay?
No. NADAC is the average price retail pharmacies pay to acquire a drug. What you pay depends on insurance, manufacturer programs, coupons and the pharmacy.
How often does this update?
Daily. NADAC changes weekly, novel drug approvals as FDA posts them, and the AI device list when FDA refreshes it.
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