BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating quality-criteria verification on DICOM images and frames; it is a concurrent reading aid for the labeled GE ultrasound and prenatal population.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating quality-criteria verification on DICOM images and frames; it is a concurrent reading aid for the labeled GE ultrasound and prenatal population.
FDA source Exact FDA submission Checked 2026-09-05
Still fetal ultrasound DICOM instances or individual frames from multiframe instances from GE ultrasound devices; images are submitted during or after the examination.
FDA source Exact FDA submission Checked 2026-09-05
Validated only with GE ultrasound; not intended for maternal ages outside 18-44 or gestation below 18 weeks, with validation covering 18-39 weeks. Quality assessment concerns expected structure presence. An unrecognized structure requires clinical review and does not itself establish a fetal anomaly.
FDA source Exact FDA submission Checked 2026-09-05
The comparison table says Real Time: No, despite real-time wording elsewhere in the description; no streaming or latency guarantee is assigned.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K250959
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Client-provided DIMSE connectivity exports ultrasound DICOM to the BioticsAI DICOM Adapter; populated reports can be exported to the clinic PACS as DICOM SR over DIMSE.
FDA source Exact FDA submission Checked 2026-09-05
Vendor confirmation Exact FDA submission Checked 2026-09-05
Regulatory cybersecurity testing and cloud descriptions do not establish a current scoped attestation, retention policy, region or installed access controls.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
Exact onboarding, competency, handling of unsupported views and support commitments require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
Editorial acceptance questions: verify missing-view/manual-review handling, maternal/gestational eligibility and DICOM SR export against local protocols; no supplied monitoring service is verified.
Official product-family workflow
BioticsAI's official site describes fetal-screening completeness/quality assessment and report generation, and provides a demonstration request route.
product family · checked 2026-09-05
Broader marketing statements about identifying fetal anomalies and real-time feedback are not treated as exact K250959 indications or validated outcomes.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Exact FDA standalone evidence establishes anatomy/plane/structure classification endpoints. It does not establish the official homepage's broader anomaly-detection or real-time outcome claims.
Public source Exact FDA submission Checked 2026-09-05
AI-1 detection of abdomen, face, head, limbs and thorax sections across all image qualities, FDA Table 7 in 11,186 fetal ultrasound images from 296 patients at one US site; GE acquisitions within labeled maternal/gestational ranges.
Tested version: BioticsAI model submitted in K250959
AI-1 detection of abdomen, face, head, limbs and thorax sections across all image qualities, FDA Table 7 in 11,186 fetal ultrasound images from 296 patients at one US site; GE acquisitions within labeled maternal/gestational ranges.
Tested version: BioticsAI model submitted in K250959
Manufacturer held-out standalone testing across anatomy, plane and anatomical-structure classification tasks · 11,186 images from 296 patients at one US site, including variation in BMI, ethnicity, gestational age, twins and abnormalities
exact submission · Tested version: BioticsAI configuration in K250959 · n=296 · 1 site · Sponsor or vendor study
K250959
Multiple imaging units at a single site. Dataset excluded development/operating-point selection data. Reference-annotation details remain incompletely abstracted; no prospective patient-outcome claim is made.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-05
The official site offers demo/sales contact but no verified price, unit, minimum volume or implementation/support fee for K250959.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-05
Applicable CMS policy content has not been reviewed; fetal ultrasound service billing is not assigned as product reimbursement.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify security and privacy controls: Regulatory cybersecurity testing and cloud descriptions do not establish a current scoped attestation, retention policy, region or installed access controls.
Verify training: Exact onboarding, competency, handling of unsupported views and support commitments require current vendor documentation.
Verify pricing and total cost: The official site offers demo/sales contact but no verified price, unit, minimum volume or implementation/support fee for K250959.
Verify reimbursement and coding relevance: Applicable CMS policy content has not been reviewed; fetal ultrasound service billing is not assigned as product reimbursement.
Verify local validation and lifecycle monitoring: Editorial acceptance questions: verify missing-view/manual-review handling, maternal/gestational eligibility and DICOM SR export against local protocols; no supplied monitoring service is verified.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
23Fields reviewed
11Source classes checked
1Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored prospective fetal-anatomy classification title/date screened. Live page established citation DOI 10.1002/ijgo.70779, but subsequent abstract retrieval was blank. Exact tested device/version and methods remain unresolved; no study or metric promoted. Stored trial array empty. The current discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
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Concurrent or post-exam fetal ultrasound aid that identifies and characterizes eight abnormal findings for interpreting-physician review; not the sole basis for management.