Company and Stock Identity

How ScreenPoint Medical Connects to the Public Market

Company structure
Private company
Market access
No current public listing was verified.
Research focus
Transpara is sold into national screening programs, so read the trial results before the marketing numbers. The company's evidence page lists the studies, including the MASAI randomized trial, and a randomized trial result is a different kind of proof than a reader study.

ScreenPoint Medical was founded in 2014 by Professor Nico Karssemeijer and Professor Sir Michael Brady, and files with the FDA as the Dutch entity Screenpoint Medical B.V. The company says healthcare and technology investors back it but does not publish amounts or dates. No ownership change was found as of October 10, 2026.

Open the public company market data feed for the full directory, ownership relationships, stock identifiers, and dated snapshots.

First-Hand Company News

Latest Developments

... FDA 510(k) premarket notification database ... Regulatory record

FDA clears Transpara 2.1.0 for ScreenPoint Medical as a Special 510(k)

The FDA premarket notification record for K260898 names the device as Transpara (2.1.0), the applicant as Screenpoint Medical B.V., and the decision date as 14 August 2026, with a decision description of substantially equivalent. The record lists the product code as QDQ, the regulation name as radiology, and the type of submission as Special. A Special 510(k) is the route used for a modification to a device the applicant has already had cleared. The record states a clearance and does not state any finding about clinical performance. This is the seventh Transpara clearance in this site's own device records for that applicant, which also list K241831 from November 2024, K221347, K210404, K193229, K192287 and K181704 going back to 2018.

Why it matters: Clearance is a market permission, not a performance grade. The FDA found this version substantially equivalent to a device already on the market, which is a comparison to a predecessor rather than a judgement that the software helps radiologists. The reason to care is version control. ScreenPoint now has seven clearances across eight years for the same product family, and the published trial evidence people quote was generated on a particular version. Before signing anything, a buyer should make the contract name the cleared version being installed, because a product name alone no longer identifies what was tested or what was cleared.

... ScreenPoint Medical ... Company source

ScreenPoint Medical reports the MASAI trial found 12 percent fewer interval cancers with Transpara

ScreenPoint Medical posted on 30 January 2026 that the final results of the MASAI trial, short for Mammography Screening with Artificial Intelligence, had been published in The Lancet. The company says the trial randomly assigned more than 105,000 women to screening supported by its Transpara software or to standard double reading, and was led by Dr Kristina Lang at Lund University. The figures ScreenPoint reports from the publication are a 12 percent lower rate of interval cancers, meaning cancers found between screening rounds, 27 percent fewer of the more aggressive non-luminal A interval cancers, a 29 percent higher cancer detection rate, 16 percent fewer invasive cancers and 21 percent fewer large T2 or greater cancers in the AI-supported group, sensitivity of 80.5 percent against 73.8 percent, and a 44 percent lower screen-reading workload. Dr Lang is quoted saying earlier detection may make a meaningful difference for women and their health, and chief executive Pieter Kroese is quoted saying that at this level of evidence the question shifts from whether AI should be used to making sure women everywhere benefit. This site's own FDA device records list Transpara clearance K241831, decided on 25 November 2024, to applicant Screenpoint Medical B.V. ScreenPoint's page additionally names 510(k) K232096 and CE marking 0344, which are the company's own statements rather than entries in this site's records.

Why it matters: A randomised trial is a different class of evidence from the retrospective reviews most imaging AI companies publish, because nobody chose which women went into which group. That is why this one is worth reading closely rather than filing with the rest. Two cautions go with it. The trial ran inside a screening program that uses two radiologists on every scan as standard, so the workload saving will not transfer unchanged to a program with one reader, and neither will the comparison. And the interval cancer figure, which is the number that matters most for whether screening is catching disease early enough, is a 12 percent relative reduction, which sounds larger in a headline than it will look in one program's annual counts. The results do not say Transpara will produce the same figures in another population, and a buyer should ask about reader staffing before using these numbers in a business case.

See company developments across the healthcare AI market.

Careers and Qualifications

What to Know Before Applying

Work areas: The company describes a global team across Europe and the USA, and asks candidates to apply through its open positions portal rather than by email.

Qualification signal: Breast imaging and screening-program experience is the signal that matters, because this product is judged inside a national screening workflow rather than on a benchmark dataset.

Check current roles at ScreenPoint Medical. 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

ScreenPoint Medical appears on 7 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