Laboratory and hematology diagnostics
Mindray MC-80
Automated digital morphology analyzer that captures blood smear images and pre-classifies cells so trained laboratory staff can review morphology more consistently.
Last updated: June 14, 2026
Back to directoryPixCell HemoScreen medical AI product profile
Portable point-of-care hematology analyzer that uses AI-assisted VEF technology to produce CBC and 5-part differential results from small blood samples.
Laboratory and hematology diagnostics
Best fit
Care settings that need rapid CBC testing near the patient with laboratory oversight, quality controls, and a defined abnormal-result escalation path.
- Primary use case
- AI-assisted point-of-care complete blood count analyzer with 5-part differential from capillary or venous whole blood
- Audience
- Point-of-care testing programs, clinical laboratories, emergency departments, outpatient clinics, field hospitals, VA sites, and health systems needing rapid CBC testing
- Risk level
- High
- Pricing signal
- Analyzer, cartridge, control, service, distributor, and implementation pricing is not public; verify current regional availability and supply terms.
- Official sources
- 5 official sources
Compare within workflow: Laboratory and hematology diagnostics · comparison shortlist · source index
Regulatory snapshot
| Status | FDA 510(k) cleared for HemoScreen hematology analyzer workflows, including later direct capillary sampling clearance; verify exact current label. |
|---|---|
| Review route | 510(k) |
| Intended use | Point-of-care automated hematology analyzer for CBC parameters and 5-part leukocyte differential in capillary and venous whole blood for adults and children at least two years old. |
| Verification note | Confirm K180020 and K222148, CLIA complexity, cartridge and QC requirements, sample type, patient age, and regional availability before clinical use. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf22 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating PixCell HemoScreen as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a regulated point-of-care in vitro diagnostic analyzer. Verify K180020, K222148, current labeling, CLIA complexity, IVDR or CE status, sample type, and patient age before use. |
|---|---|
| Privacy | Review instrument connectivity, sample identifiers, LIS middleware, QC records, service access, result storage, audit logs, and whether any remote support or cloud data flow exists. |
| Evidence | Validate CBC and 5-part differential results locally against reference analyzers, including capillary collection variability, abnormal flags, pediatric use, low-volume settings, and operator competency. |
| Workflow | Best governed through POCT committee or laboratory director oversight, QC procedures, cartridge controls, operator training, abnormal-result escalation, LIS reconciliation, and periodic proficiency review. |
Where PixCell HemoScreen fits
PixCell describes HemoScreen as an FDA-cleared point-of-care 5-part differential CBC analyzer using AI-assisted viscoelastic focusing technology. FDA records list HemoScreen clearances, including direct capillary sampling updates, and public product materials describe capillary or venous whole-blood CBC use with quality-control requirements.
Not for: Unsupervised diagnosis, unsupported patient ages or specimens, waived-testing assumptions not supported by the label, or use without QC and medical-director oversight.
What to verify before using PixCell HemoScreen
- Current FDA, IVDR, CE, CLIA complexity, patient-age, direct capillary sampling, venous sample, and point-of-care claims for the exact model and cartridge.
- How cartridges, samplers, QC materials, calibration, abnormal flags, LIS integration, result correction, and operator lockout or training controls work.
- Local comparison with reference analyzers across capillary and venous specimens, pediatrics, low counts, abnormal flags, clozapine monitoring, and emergency workflows.
- Supply-chain reliability for cartridges and controls, downtime procedures, infection-control workflow, connectivity, support access, and audit trail review.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.pixcell-medical.com / hemoscreen
- www.pixcell-medical.com
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / cdrh_docs / pdf22
- pmc.ncbi.nlm.nih.gov / articles / PMC9713220
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