Breaking Wave Capital Unveils Whitepaper on How AI Is Reshaping Healthcare Innovation and Investment

PR Newswire
Wednesday, October 8, 2025 at 4:26pm UTC

Breaking Wave Capital Unveils Whitepaper on How AI Is Reshaping Healthcare Innovation and Investment

PR Newswire

Breaking Wave Capital (BWC) has launched its debut venture fund to invest in growth-stage companies transforming healthcare, wellness, technology, media, and sustainability. Founded by seasoned operators Pamela Hall and Robert M. Herzog, BWC is designed to provide more than capital; offering hands-on partnership from leaders with decades of experience scaling businesses across industries. Their operator-led approach sets them apart from traditional financial investors, with a track record that includes over $1.25 billion in transactions, more than 20 exits, and two IPOs. BWC is particularly focused on the rapidly evolving digital health and AI sectors, where funding has stabilized and AI-enabled startups now dominate investment flows. The firm targets Series A and B companies with proven traction, deploying $2M–$10M investments and actively guiding founders on scaling operations, navigating regulations, and growth strategy. With sector priorities spanning healthcare, wellness, AI, media, and sustainability, BWC brings a disciplined strategy backed by real-world operational expertise and shares deeper insights in its new whitepaper, AI Healthcare & Wellness: U.S. Market Analysis (October 2025).

NEW YORK CITY, Oct. 8, 2025 /PRNewswire-PRWeb/ -- Breaking Wave Capital: AI Healthcare & Wellness - U.S. Market Analysis (October 2025)

1. Executive summary

  • Funding has stabilized with an AI tilt. U.S. digital health raised $6.4B across ~245 deals in Q1'25; for the first time, AI-enabled startups captured a majority (≈62%) and raised ~$34.4M per round vs. ~$18.8M for non-AI peers.
  • Where value is accruing: GenAI's near-term ROI concentrates in administrative efficiency (documentation, prior authorization), clinical productivity (ambient scribing, care coordination), and member engagement—with patient-facing wellness rising via data aggregation + AI guidance.
  • Regulatory momentum lowers go-to-market friction:
  • CMS Interoperability & Prior Authorization Final Rule (CMS-0057-F) pushes payer APIs; most API requirements are due Jan 1, 2027 (some provisions 2026), which structurally benefits AI automation around prior authorization and data exchange.
  • ONC HTI-1 "Decision Support Interventions" adds AI transparency labeling into certified EHRs (effective Feb 8, 2024, with phased timelines into 2026), easing provider adoption of AI decision support
  • FTC's updated Health Breach Notification Rule (HBNR) explicitly covers health apps (effective July 29, 2024), raising the data-privacy bar for wellness and consumer apps.
  • Clinical AI is mainstreaming: FDA now lists 1,000+ AI/ML-enabled devices cleared/authorized; imaging still dominates, but use cases are diversifying beyond radiology.
  • Opportunities: Select companies utilizing AI with clear outcomes, efficiency enhancements, and data analysis and integration present significant near term market opportunities when coupled with meaningful support and funding.

2. Market map & sub-verticals

  • Ambient clinical documentation & administrative automation - scribes, CDI/coding, call-center AI, prior-authorization agents
  • Care navigation & engagement - member copilots, post-discharge outreach, adherence
  • Clinical search & decision support - retrieval-grounded medical answers for clinicians
  • Diagnostics & imaging AI; triage, detection, workflow; expanding beyond radiology
  • Landscape: FDA's AI device list shows accelerating clearances in 2025.
  • Personalized wellness & preventive health — labs + wearables + AI guidance, consumer UX

3. Demand drivers

  • Labor shortages & burnout push providers to adopt time-savers (ambient scribing, intake, coding).
  • Payer API mandates (CMS-0057-F) create tailwinds for prior-authorization automation and data liquidity - fertile ground for AI agents.
  • Consumerization of health - people expect continuous, data-driven guidance, not annual checkups; Function-style lab+imaging bundles exemplify willingness to pay.

4. Headwinds & risks

  • Regulatory + privacy complexity: HTI-1 transparency requirements and FTC HBNR raise compliance costs for non-HIPAA wellness apps; missteps invite enforcement.
  • Clinical validity & liability: Many FDA-cleared AI devices focus on image analysis; LLM-based devices are rare in approvals so far; evidence standards remain strict.
  • Integration burden: Health-system sales still hinge on EHR integration, change-management, and clear ROI vs. baseline workflows.

5. 12-month Outlook (what to watch)

  • Payer API build-outs (2026–2027 deadlines) → growth in prior-authorization & claims-automation platforms; watch vendor partnerships with MA and Medicaid plans.
  • Ambient & call-center AI stack consolidation (scribes + scheduling + rev-cycle) as buyers prefer bundled SKUs.
  • Wellness platforms move "up-funnel" into preventive diagnostics (labs + imaging) with clearer outcomes & pricing (e.g., Function Health + Ezra).
  • More FDA clearances beyond imaging; gradual emergence of validated LLM-adjacent tools for clinical decision support.

6. Implications for Breaking Wave Capital Investment Strategy

  • Attractive near-term ROI: ambient documentation, coding/CDI, call-center automation, and prior-authorization - fast paybacks and compliance tailwinds.
  • Wellness thesis: back data-rich guidance platforms that fuse labs, wearables, and imaging with clear outcomes and privacy compliance.

References:

https://rockhealth.com/rock-weekly/2025-half-year-funding-6-4b-across-245-deals/#:~:text=H1%202025%20marked%20a%20season,%246.2B%20in%20H1%202023

https://www.mckinsey.com/industries/healthcare/our-insights/generative-ai-in-healthcare-current-trends-and-future-outlook

https://www.cms.gov/priorities/burden-reduction/overview/interoperability/policies-and-regulations/cms-interoperability-and-prior-authorization-final-rule-cms-0057-f/cms-interoperability-and-prior-authorization-final-rule-cms-0057-f

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

https://rockhealth.com/insights/h1-2025-market-overview-proof-in-the-pudding/#:~:text=The%20first%20half%20of%202025,for%20longstanding%20digital%20health%20darlings.

https://time.com/collections/time100-companies-2025/7289585/function-health/

https://www.fiercehealthcare.com/health-tech/function-health-acquires-ezra-combine-lab-testing-and-ai-powered-medical-imaging

Media Contact
dashiell Llewellyn, Breaking Wave Capital, 1 6094754103, dashl@breakingwavecap.com, breakingwavecapital.com 

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SOURCE Breaking Wave Capital