Roundup · ranked by clearances

Best FDA-cleared AI anesthesiology devices (2026)

The companies with the most FDA-cleared AI anesthesiology devices through June 29, 2026 are Huxley Medical (4), Tyto Care, Ltd. (4) and Intelligent Ultrasound Limited (2). This is a count of final decisions on the FDA list. It is not a ranking of clinical performance.

How this ranking works

Each row is one applicant name on the FDA AI-enabled device list, limited to devices whose lead review panel is Anesthesiology. Affiliated companies are not merged. A company needs at least two anesthesiology devices to appear in the top list. 20 other companies have exactly one. The full catalog is the anesthesiology specialty page.

Top companies

  1. 1

    Huxley Medical

    Huxley Medical has 4 FDA-listed AI anesthesiology devices (13.3% of this specialty), with decisions from 2024–2025. The latest is SANSA HSAT (K252497) on December 10, 2025. Most common product code: MNR (Ventilatory Effort Recorder), 4 devices.

  2. 2

    Tyto Care, Ltd.

    Tyto Care, Ltd. has 4 FDA-listed AI anesthesiology devices (13.3% of this specialty), with decisions from 2023–2026. The latest is Tyto Insights for Wheeze Detection (with PCCP) (K252844) on June 2, 2026. Most common product code: PHZ (Abnormal Breath Sound Device), 4 devices.

  3. 3

    Intelligent Ultrasound Limited

    Intelligent Ultrasound Limited has 2 FDA-listed AI anesthesiology devices (6.7% of this specialty), with decisions from 2022–2023. The latest is ScanNav Anatomy Peripheral Nerve Block (K232787) on October 6, 2023. Most common product code: QRG (Ultrasound Guided Nerve Block Assist), 2 devices.

Newest anesthesiology clearances

The six most recent anesthesiology decisions on the list. All specialties in 2026

Radiology1230Cardiovascular154Neurology73Gastroenterology-Urology27Hematology22

Frequently asked questions

Which company has the most FDA-cleared AI anesthesiology devices?

Huxley Medical has the most, with 4 (13.3% of anesthesiology devices on the list). Next are Tyto Care, Ltd. (4) and Intelligent Ultrasound Limited (2).

How many FDA-cleared AI anesthesiology devices are there?

The FDA AI-device list has 30 devices with Anesthesiology as the lead review panel, from 23 companies, through June 29, 2026.

Is this a ranking of the best AI anesthesiology devices clinically?

No. Companies are ordered by how many FDA final decisions they have on the AI-enabled device list. That measures how many authorized products an applicant has, not accuracy, safety, or which device to buy.

Which AI anesthesiology device was cleared most recently?

RX-1 Sleep from Vivaquant, Inc. Dba Rhythm Express (K253148), decided on June 22, 2026.

How many AI anesthesiology devices were cleared in 2026?

2026 does not have a separate anesthesiology page because fewer than five decisions are dated that year.

Cite as: AI Device Radar, “Best FDA-cleared AI anesthesiology devices (2026),” https://ai-device-radar.vercel.app/best/anesthesiology (FDA list through 2026-06-29).