Authorized purpose: HeartFocus v1.1.1 guides trained medical professionals in acquiring ten standard adult 2D transthoracic echocardiographic views using compatible ultrasound systems, with live probe guidance, image-quality feedback and recording assistance for subsequent clinical interpretation.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: HeartFocus v1.1.1 guides trained medical professionals in acquiring ten standard adult 2D transthoracic echocardiographic views using compatible ultrasound systems, with live probe guidance, image-quality feedback and recording assistance for subsequent clinical interpretation.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: HeartFocus v1.1.1 guides trained medical professionals in acquiring ten standard adult 2D transthoracic echocardiographic views using compatible ultrasound systems, with live probe guidance, image-quality feedback and recording assistance for subsequent clinical interpretation.
Which images or clinical context are in scope?Modality: Ultrasound Anatomy or clinical context: Heart/Cardiovascular Input: Live adult 2D-TTE ultrasound stream; initial compatibility lists Clarius PAHD3 wireless, PAHD, PAL and Clarius Ultrasound Scanner Software. Views: PLAX, PSAX-AV/MV/PM, A4C/A5C/A2C/A3C, SC-4C and SC-IVC.
Who uses it?Intended users: Medical professionals trained in ultrasound basics and HeartFocus use, including trained nurses, physicians and sonographers
What does the software produce?Output: Probe-position guidance cues, color-coded diagnostic-quality feedback, Auto Record, Best-Effort Record and recorded-clip quality information; acquired exams are available for clinician review and transfer.
What is its most important limitation?Key limitation: Adult acquisition aid requiring trained users and qualified interpretation. Clinical-study image quality varied by view, particularly subcostal IVC. PCCP allows specified compatibility changes after validation; it does not establish that every current probe/OS was tested in the initial v1.1.1 study.
Clinical takeaway
Clinical role: HeartFocus v1.1.1 guides trained medical professionals in acquiring ten standard adult 2D transthoracic echocardiographic views using compatible ultrasound systems, with live probe guidance, image-quality feedback and recording assistance for subsequent clinical interpretation.
Evidence takeaway
Evidence from the reviewed source record: The initial Clarius/v1.1.1 evidence supports trained-user image acquisition with expert interpretation. Current Butterfly family features and commercial terms cannot be used as original-study results.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
HeartFocus v1.1.1 guides trained medical professionals in acquiring ten standard adult 2D transthoracic echocardiographic views using compatible ultrasound systems, with live probe guidance, image-quality feedback and recording assistance for subsequent clinical interpretation.
Probe-position guidance cues, color-coded diagnostic-quality feedback, Auto Record, Best-Effort Record and recorded-clip quality information; acquired exams are available for clinician review and transfer.
Adult acquisition aid requiring trained users and qualified interpretation. Clinical-study image quality varied by view, particularly subcostal IVC. PCCP allows specified compatibility changes after validation; it does not establish that every current probe/OS was tested in the initial v1.1.1 study.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
The FDA summary describes an offline application with medical data stored locally on the tablet and no data transfer to a DESKi-controlled server for its functions.
FDA source
Exact FDA submission
Checked 2026-09-05
Corrects the baseline's nonspecific Hybrid label using the exact summary; current device configuration remains separately scoped.
FDA-local data flow is documented, but FAQ/pricing security language does not supply a dated scoped attestation or a complete installed security-control assessment.
Training and support
Users require ultrasound-basics and HeartFocus training provided by DESKi or a trained medical professional using approved training material.
FDA source
Exact FDA submission
Checked 2026-09-05
Exact local competency sign-off, onboarding duration and contractual support remain site/vendor matters.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
The initial Clarius/v1.1.1 evidence supports trained-user image acquisition with expert interpretation. Current Butterfly family features and commercial terms cannot be used as original-study results.
A single disease-detection sensitivity is not established by the reviewed acquisition-quality studies.
Reported specificity
93.9%
FDA source
Exact FDA submission
Checked 2026-08-13
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
EndpointProportion of clips saved with Best-Effort Record judged of diagnostic image quality in the prospective acquisition study
Population240 adults aged at least 22 at one French and one US center; eight nurse operators, five blinded cardiologist assessors; recorded clips graded using ACEP scale
Tested versionHeartFocus v1.1.1 with Clarius in K242807 clinical study
DesignManufacturer prospective multicenter paired acquisition study; trained novice nurses compared with experts on the same ultrasound system, five blinded cardiologist reviewers
Population240 clinically indicated echocardiography patients aged at least 22; 120 France and 120 US
Scopeexact submission
Tested versionHeartFocus v1.1.1 with Clarius
Samplen=240
Sites2
IndependenceSponsor or vendor study
K242807
Eight nurses acquired ten views; four primary endpoints assessed examination suitability for visual LV size/function, RV size and nontrivial effusion evaluation. Secondary quality outcomes were descriptive and varied by view; not an autonomous diagnosis study.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
The current HeartFocus family pricing page displays $695 per license/year/probe or $1,800 per license/three years/probe for up to five licenses, with unlimited users; enterprise six-plus licenses require a quote.
Public source
Product family
Checked 2026-09-05
Current family offer, not an exact v1.1.1/Clarius quote. The page shows a dollar sign but no ISO currency; no normalized price observation is emitted. Hardware, tax and local contract inclusions require confirmation.
No applicable CMS policy content reviewed. Acquisition software pricing does not establish reimbursement for the software or the underlying echo service.
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: FDA-local data flow is documented, but FAQ/pricing security language does not supply a dated scoped attestation or a complete installed security-control assessment.
Verify reimbursement and coding relevance: No applicable CMS policy content reviewed. Acquisition software pricing does not establish reimbursement for the software or the underlying echo service.
Verify local validation and lifecycle monitoring: Editorial acceptance questions concern installed probe/OS/model compatibility, per-view failures, rescue scanning, saved-clip review and DICOM transfer; no vendor 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
21Fields reviewed
12Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads
Stored DESKi-sponsored PROSPECTIVE EVALUATION OF HEARTFOCUS metadata screened. Live registry page exposed only an application shell, so trial details and exact release linkage were not established; no registry result promoted. Clinical-study abstraction is sourced to the FDA summary only. Stored PubMed array empty. The current discovery snapshot contains 0 PubMed and 1 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, vendor pricing, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history8 sources - 3 history items
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