Roundup · ranked by clearances

Best FDA-cleared AI hematology devices (2026)

The companies with the most FDA-cleared AI hematology devices through June 29, 2026 are CellaVision AB (5), Bonraybio Co., LTD. (4) and Athelas, Inc. (3). 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 Hematology. Affiliated companies are not merged. A company needs at least two hematology devices to appear in the top list. 7 other companies have exactly one. The full catalog is the hematology specialty page.

Top companies

  1. 1

    CellaVision AB

    CellaVision AB has 5 FDA-listed AI hematology devices (22.7% of this specialty), with decisions from 2001–2020. The latest is CellaVision DC-1, CellaVision DC-1 PPA (K200595) on October 16, 2020. Most common product code: JOY (Device, Automated Cell-Locating), 5 devices.

  2. 2

    Bonraybio Co., LTD.

    Bonraybio Co., LTD. has 4 FDA-listed AI hematology devices (18.2% of this specialty), with decisions from 2018–2025. The latest is LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (K242830) on May 30, 2025. Most common product code: POV (Semen Analysis Device), 4 devices.

  3. 3

    Athelas, Inc.

    Athelas, Inc. has 3 FDA-listed AI hematology devices (13.6% of this specialty), with decisions from 2018–2026. The latest is Athelas Home (K243348) on February 6, 2026. Most common product code: GKZ (Counter, Differential Cell), 3 devices.

  4. 4

    Scopio Labs, Ltd.

    Scopio Labs, Ltd. has 3 FDA-listed AI hematology devices (13.6% of this specialty), with decisions from 2020–2025. The latest is X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (K243144) on June 27, 2025. Most common product code: JOY (Device, Automated Cell-Locating), 3 devices.

Newest hematology clearances

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

Radiology1230Cardiovascular154Neurology73Anesthesiology30Gastroenterology-Urology27

Frequently asked questions

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

CellaVision AB has the most, with 5 (22.7% of hematology devices on the list). Next are Bonraybio Co., LTD. (4) and Athelas, Inc. (3).

How many FDA-cleared AI hematology devices are there?

The FDA AI-device list has 22 devices with Hematology as the lead review panel, from 11 companies, through June 29, 2026.

Is this a ranking of the best AI hematology 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 hematology device was cleared most recently?

Seaman Pro/Seaman from Checkcells, Inc. (K252228), decided on April 9, 2026.

How many AI hematology devices were cleared in 2026?

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

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