Lucid Diligence Brief: Clairity’s $43 million Series B for Clairity Breast

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Dive deeper

Seven questions, 60-second thesis frame.

What changed, and when

Clairity’s $43 million Series B for Clairity Breast commercialization, described as the first FDA-authorized AI platform to predict five-year breast cancer risk from a routine mammogram, was announced on 13 Nov 2025 (Business Wire).
FDA granted De Novo classification DEN240047 on 30 May 2025 to Clairity’s Allix5 software, a radiological device that outputs a five-year breast cancer risk prediction based on a bilateral screening mammogram (FDA De Novo record DEN240047, FDA decision letter).

60-second thesis frame

A first-in-class De Novo gives Clairity a defensible regulatory position for image-only five-year risk prediction, which could shift screening pathways toward risk-based follow up if performance, workflow fit, and payer policies align (FDA De Novo record DEN240047). Early independent coverage affirms “first” status and highlights intended integration with existing clinical systems, but real-world outcomes and reimbursement remain unproven at scale (Fierce Biotech, Applied Radiation Oncology). Capital from the Series B funds commercialization and next iterations, increasing the near-term probability of multi-site pilots that could inform payer and guideline moves in 2026 (Business Wire, AuntMinnie).

The seven diligence questions

Clinical

• How does Allix5’s absolute risk calibration and discrimination perform across age, density, race, and vendor cohorts in external validation, and how does it compare head-to-head with Tyrer–Cuzick or BCSC models using the same populations (Fierce Biotech)?
• What is the clinically actionable threshold schema that sites adopt for MRI or contrast-enhanced mammography follow up, and how stable are positive and negative predictive values by site mix (Applied Radiation Oncology)?

Payer or Access

• Which codes or coverage pathways will providers use in 2025–2026, and do large US payers or PBMs issue coverage bulletins or step-edits specific to AI risk prediction versus bundled mammography services (independent verification pending)?
• What is the health economic case for lowering late-stage diagnoses or reducing unnecessary imaging, and do early adopter contracts include outcomes-based terms (Pharmacy Times)?

Ops or Adoption

• How seamlessly does Clairity integrate with PACS and reporting, and what is the median added reading time or staff workflow impact in real clinics (Applied Radiation Oncology)?

Competitive

• Are there credible image-only or hybrid competitors likely to obtain authorization in 2026, and would a predicate-based 510(k) now be available that narrows Clairity’s moat (FDA De Novo record DEN240047)?

Team or Cap table

• Does the leadership have scaled med-device commercialization and payer negotiation experience to convert radiology interest into system-level adoption, and how concentrated is investor control after the Series B (Business Wire)?

Red flags

• “First and only” positioning relies on continued category exclusivity; a follow-on device could use Clairity as predicate via 510(k) after the De Novo, compressing differentiation (FDA De Novo record DEN240047).
• Real-world impact, including mortality or stage shift, is not yet demonstrated at population scale; payer adoption could lag pending outcomes (Fierce Biotech, BCRF).
• Performance drift and demographic bias are risks if training data do not mirror local populations; regulators may scrutinize postmarket monitoring plans (AuntMinnie, July FDA AI update).

Next catalyst

RSNA 2025, Nov 30–Dec 4, with multiple Clairity presentations expected to detail external validation and workflow integration (Clairity RSNA 2025 page).

FAQ

• What exactly changed by Clairity’s $43 Million Series B news on 13 Nov 2025, and why does it matter for breast imaging services?
  The company secured funding to commercialize its FDA-authorized image-only five-year breast cancer risk platform, signaling a push from pilots to scaled rollouts in 2026 (Business Wire, AuntMinnie coverage).
• What is the regulatory path after the 30 May 2025 De Novo authorization of Clairity’s device, and what are the next formal steps in the US, UK, and EU?
  The US device now has a new classification and product code SEZ, enabling future 510(k) predicates; UK and EU market entry would require separate pathways such as UKCA or EU MDR CE marking (FDA De Novo record DEN240047).
• Which endpoints or metrics underpinned the De Novo authorization of Clairity’s device and how meaningful were they?
  FDA describes a software device that generates a five-year risk prediction from bilateral screening mammograms; sponsors typically support with calibration and discrimination metrics against standard models, details in the decision letter and summaries (FDA decision letter, Applied Radiation Oncology overview).
• What safety or labeling considerations matter post-authorization of Clairity’s device, and do they change real-world use?
  The device is not intended to diagnose, detect, or guide interpretation of imaging exams, so providers must avoid using risk outputs as diagnostic findings, focusing on risk-based follow up protocols instead (AuntMinnie, July FDA AI update).
• How will major US payers likely treat access after Clairity’s device authorization, and are codes available?
  Independent reporting emphasizes promise but does not confirm specific coverage or coding; early adopters may proceed under local payment arrangements while evidence for economic benefit accrues (Pharmacy Times, Fierce Biotech).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 13 Nov 2025, London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2025 LucidQuest Ventures Ltd.

Entities / Keywords

Clairity; Allix5; DEN240047; FDA CDRH; product code SEZ; five-year breast cancer risk; mammography; screening mammogram; image-only risk model; Tyrer–Cuzick; BCSC; PACS; radiology workflow; RSNA 2025; payer coverage; CPT; HCPCS; outcomes-based contracts; MRI follow up; contrast-enhanced mammography; health equity; calibration; discrimination; external validation; De Novo; 510(k) predicate; US market; UKCA; EU MDR; PBM; health systems; radiologists.

 

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