Company and Stock Identity

How BrightHeart Connects to the Public Market

Company structure
Private company
Market access
No current public listing was verified.
Research focus
Separate the two products and the two markets before comparing anything. B-Right Views and B-Right Screen each carry their own Class II FDA clearance and their own Class IIa CE mark, so a claim about one is not a claim about both. The company's own evidence sits in a 2025 study in Obstetrics and Gynecology and the clearance paperwork, so ask which version of the software each one tested and how many centres took part.

BrightHeart announced an 11 million euro Series A on 9 January 2026, co-led by Odyssee Venture and GO Capital, with founding investor Sofinnova Partners among those taking part. No change of control was announced. Checked on 2026-10-10.

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First-Hand Company News

Latest Developments

... BrightHeart ... Company source

BrightHeart gets a CE mark and starts selling its prenatal ultrasound AI in Europe

BrightHeart said on 8 July 2026 that it received a CE mark and is launching its B-Right AI platform across the European Union, with its European debut at the Fetal Medicine Foundation World Congress in Vienna held from 28 June to 2 July 2026. The company states that both B-Right Views and B-Right Screen are Class II FDA cleared and Class IIa CE marked, with notified body 3022.

Why it matters: Two approvals in two systems is the practical difference between a pilot and a product a European hospital group can buy. The two products are cleared and marked separately, so a buyer should check which one covers the job in front of them rather than treating the platform as a single permission. Neither approval says anything about how many heart defects the software will find in a particular clinic, which is a question for the evidence, not the paperwork.

... BrightHeart ... Company source

BrightHeart puts its fetal heart AI in GE HealthCare's Voluson store

BrightHeart said on 6 February 2026 that its B-Right AI platform is available through GE HealthCare's Voluson Solution Store. The company says the collaboration is meant to improve early detection of congenital defects and reduce uncertainty in reading a prenatal scan. It repeats that B-Right Views and B-Right Screen are each Class II FDA cleared and Class IIa CE marked under notified body 3022.

Why it matters: A scanner maker's own store is the cheapest way for a small vendor to reach the people already using that machine, and the Voluson line is widely used in obstetric ultrasound. It also makes the software easier to buy than to compare, so a department should still ask for the evidence rather than treating a listing as a recommendation. GE HealthCare distributing a product is not GE HealthCare validating it, and the clearances remain BrightHeart's.

... BrightHeart ... Company source

BrightHeart raises 11 million euros to grow its prenatal ultrasound AI

BrightHeart said on 9 January 2026 that it raised 11 million euros in a Series A round co-led by Odyssee Venture and GO Capital. The company names Mussallem CHD Alliance, Lift Value, the IDAHO HealthTech Club through Side Angels, founding investor Sofinnova Partners, Professor Laurent Salomon, Sacha Loiseau and John Gridley among those taking part. The announcement says the money is for scaling the B-Right platform and does not break down how it will be spent.

Why it matters: A Series A of this size buys a few years, not a decade, which is the honest way for a hospital to read it when signing a multi-year workflow. The investor list leans European, and the round landed six months before the CE mark, so the funding and the European launch read as one plan rather than two events. For a candidate, the useful detail is that the company is still small enough that a single hire changes the roadmap.

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Careers and Qualifications

What to Know Before Applying

Work areas: BrightHeart keeps its hiring information on an outside Notion page linked from its own site rather than on a careers page it controls, so openings are only visible there.

Qualification signal: This product is used live, while a sonographer is scanning, so people who understand how a fetal heart exam is actually performed count as much as model builders. Fetal cardiology experience is the scarce part.

Check current roles at BrightHeart. A careers page is the source of record for openings. This profile does not claim a role is open unless the company lists it now.

Related Healthcare AI Roles

Training to Compare

Buyer Snapshot

Best-fit buyer
Radiology leadership, pathology leadership, clinical informatics, imaging IT, patient safety, and procurement
Primary use case
Triage studies, flag findings, support image interpretation, and coordinate time-sensitive care
Typical deployment
Usually integrated with PACS, RIS, worklists, or digital pathology systems and monitored inside the clinical workflow

Evidence questions

  • Was the tool tested prospectively and independently on comparable equipment and patients?
  • What are sensitivity, specificity, false positive workload, and time-to-action effects?
  • How does performance vary by site, scanner, demographic subgroup, and disease prevalence?

Regulatory and workflow questions

  • Which FDA authorization covers the exact product version, modality, and intended use?
  • Who retains final clinical responsibility and how is disagreement with the AI handled?
  • What post-deployment monitoring and material update notification does the vendor provide?

Data and contract questions

  • Where are images and derived data processed and retained?
  • Which PACS, RIS, pathology, and EHR integrations are supported in production?
  • Can data be used for model improvement, and what controls govern secondary use?

Evidence and Regulation

FDA Clearances on Record

BrightHeart appears on 3 cleared products in the federal 510(k) record, across 1 device type.

A clearance means the FDA agreed the product is close enough to something already on the market to be sold for that use. It is not a finding that the product helps patients, and it is not a ranking against anything else on this page. A company is linked to an FDA clearance only when the 510(k) applicant name on the government record is confirmed by hand to be that same company, including former corporate names. Name similarity alone is never enough, and rejected matches are listed below with the reason.

What the Published Research Says About This Work

Independent studies on the work itself help separate category evidence from one company's claims.

First-Hand Sources