Lucid Diligence Brief: Function Health raises $298M Series B at $2.5B

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Dive deeper

Seven questions, 60-second thesis frame.

What changed, and when

Function Health raises $298M Series B at $2.5B valuation, led by Redpoint Ventures (news released on 19 Nov 2025), unveiling its Medical Intelligence Lab, a clinician-guided AI layer across labs, imaging, records and wearables (Company press release, TechCrunch, Fierce Healthcare).
The raise follows Function’s May 2025 acquisition of Ezra to add fast full-body MRI and CT options, anchored by FDA-cleared imaging AI (Function–Ezra acquisition PR, Fierce Healthcare).

60-second thesis frame

Signal quality is rising, but clinical utility is still debated. Function now combines a large cash war chest, strong distribution via Quest sites and 130 MRI locations, and a unified data model staffed by named clinical leaders, which can lift consumer adoption and data moats if safety, accuracy and workflow claims hold. Funding and MI Lab are well-sourced, Ezra’s AI has specific 510(k) clearances, and membership pricing dropped to $365, supporting volume. The risk is clinical controversy around whole-body screening, payer cash-pay dynamics, and evolving test oversight, so proof points must shift from marketing to outcomes and benign false-positive rates (TechCrunch, FDA 510(k) Ezra Flash/Prostate AI, Ezra FDA clearance note, Function pricing).

The seven diligence questions

Clinical

• What prospective evidence shows MI Lab plus labs and imaging improves hard outcomes, for example reduced late-stage cancer incidence or cardiovascular events versus usual care, and at what false-positive rate, downstream procedures and adverse events (ACR statement on total-body MRI, Peer-review overview).
• Which exact AI devices are FDA-cleared, for what indications and modalities, and how do they map to the marketed 22-minute scan protocol. Provide 510(k) numbers and performance metrics (FDA 510(k) Ezra Plexo/Flash, Ezra Flash 510(k) summary).

Payer or Access

• What portion of revenue is sustainable as cash-pay, and where do HSA/FSA eligibility and state-specific lab billing rules constrain uptake, especially New York and New Jersey (Function pricing notes, Fierce Healthcare).
• If lab-developed test oversight shifts again, could compliance costs rise or marketing claims narrow, and how is risk managed with Quest or other CLIA partners (FDA LDT rule rescission summary, Reuters recap).

Ops or Adoption

• Can Function scale MRI sites from 130 to 200 by year-end 2025 and maintain turnaround times, radiologist capacity and quality control. What is current backlog and NPS by market (TechCrunch).

Competitive

• Against Prenuvo, Neko Health, Superpower and InsideTracker, where does Function have defensible cost, speed, accuracy or breadth, for example 2,000 Quest draw sites and integrated AI protocols. Provide apples-to-apples benchmarks (TechCrunch).

Team or Cap table

• Post-round governance and hiring plan, including the remit for Chief Medical Scientist Dan Sodickson and any board seats for Redpoint or a16z, plus how celebrity and strategic investors are ring-fenced from clinical decisions (Company press release, Fierce Healthcare).

Red flags

• Whole-body screening remains controversial for asymptomatic people, with professional societies citing insufficient evidence and risk of incidentalomas, overdiagnosis and follow-on harms. Track guideline shifts (ACR statement, Michigan Medicine explainer).
• Company-claimed scale, for example “50M+ lab tests since 2023,” lacks independent validation and may represent biomarker counts not unique users. Treat as unverified until audited (TechCrunch, Company press release).
• Regulatory whiplash around LDT oversight could return, adding cost or constraining product claims if rules are re-imposed (FDA LDT page, Reuters).

Next catalyst

Site expansion cadence and MI Lab feature roll-out in Q4 2025, including growth from 130 to a targeted 200 MRI locations and broader Quest access, with any updated investor or product notes (TechCrunch).

FAQ

• What exactly changed by Function Health’s news on latest raise on 19 Nov 2025, and why does it matter for preventive health?
  Function closed a $298M Series B at a $2.5B valuation and launched a clinician-guided AI layer that unifies labs, imaging, records and wearables, aiming to shift from reactive to proactive care. This expands the platform beyond lab memberships to integrated medical intelligence (Company press release, TechCrunch).
• What is the regulatory path after Function Health’s $298M Series B raise news on 19 Nov 2025, and what are the next formal steps in the US, UK and EU?
  Ezra’s AI components used by Function have discrete US FDA 510(k) clearances, for example Ezra Flash and prostate MRI tools, while broader MI features are positioned as decision support and education rather than diagnostic replacements. UK and EU deployment would require UKCA or CE marking where the AI is a regulated device (FDA 510(k) summary, Ezra FDA clearance note).
• Which endpoints in the Function–Ezra program informed the 22-minute scan claim in the 19 Nov 2025 announcement, and how meaningful is it?
  The time reduction is attributed to Ezra Flash AI image enhancement, with 510(k) supporting documents and company disclosures rather than peer-reviewed outcome trials; clinical benefit depends on detection quality and low false positives. Independent societies still flag insufficient evidence for routine whole-body screening (FDA 510(k) Ezra Flash, ACR statement).
• What safety issues matter post–launch of Function Health’s Medical Intelligence Lab on 19 Nov 2025, and do they change real-world use?
  MRI avoids ionizing radiation, but incidental findings can drive invasive follow-ups, anxiety and cost; CT options add radiation exposure that must be justified. Clinician oversight and conservative protocols are key to mitigate harm (ACR CT position, Michigan Medicine explainer).
• How will major US payers treat access after Function Health’s news on 19 Nov 2025, including prior auth or step edits, and are codes available?
  Function is positioned as cash-pay with HSA/FSA eligibility, so traditional prior authorization is not applicable; radiology CPT codes exist for diagnostic MRIs, but full-body screening is typically not covered. State rules and new MR-safety codes may affect provider economics, not consumer coverage (Fierce Healthcare, ACR bulletin on MR safety codes).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 22 Nov 2025, 11:00 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

Function Health; Medical Intelligence Lab; Ezra; Ezra Flash; Redpoint Ventures; Andreessen Horowitz; Quest Diagnostics; Dan Sodickson; Mark Hyman; Jonathan Swerdlin; HIPAA; FDA; 510(k); LDT; USPSTF; ACR; whole-body MRI; CT screening; preventive health; biomarkers; lab testing; pricing $365; $499 MRI; cash-pay; HSA/FSA; New York; New Jersey; Neko Health; Prenuvo; InsideTracker; Superpower; radiology capacity; data privacy; longitudinal data; clinical utility; false positives; incidentalomas; CLIA; CE mark; UKCA.

 

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