Free · FDA decisions through June 29, 2026

AI Device Radar Weekly

New FDA clearances of AI-enabled medical devices, with the companies and the numbers behind them. Read every issue here. Join the list and the next one is sent to you as well.

AI Device Radar Weekly

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One email when a new issue is published. The archive stays on this page either way.

The clearances

Every FDA AI-device decision dated after the previous issue, with the submission number, company and specialty.

The highlights

First-time companies, repeated product codes, and any De Novo or PMA decision in the window.

The counts

Which specialty led, and how the year-to-date total sits against the full FDA list of 1,614 devices.

Archive

Issue 1 · June 24–29, 2026

7 FDA AI clearances

7 AI-enabled medical devices received an FDA decision from June 24, 2026 to June 29, 2026. Radiology accounts for 6 of the 7. The newest is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC (K260667).

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Every issue keeps an open sponsor slot for a company with an FDA-cleared AI device. The slot links to the existing request form.

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Frequently asked questions

What is AI Device Radar Weekly?

A free issue-by-issue record of FDA final decisions on AI-enabled medical devices: the new clearances since the previous issue, the companies, and the counts. Every issue stays on this site.

How much does it cost?

Nothing. Subscribe with an email address. There is no paid tier.

How often is a new issue published?

When the FDA list gains decision dates newer than the previous issue. The first issue covers the seven days ending on the latest decision in the dataset.

Can a company sponsor an issue?

Yes. Each issue reserves a sponsor slot. The request form is on the sponsor page, and it does not change the device data.

Cite as: AI Device Radar, “AI Device Radar Weekly,” https://ai-device-radar.vercel.app/newsletter (FDA list through 2026-06-29).

AI Device Radar Weekly

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