Hilo (formerly Aktiia) secured $30M in Series B funding, accelerating FDA submission for its optical blood pressure algorithm. With CE marking and Epic EHR integration, the company bridges consumer wearables and clinical applications amid growing investor interest in preventive healthcare AI solutions.
The recent $30M Series B funding round for Hilo, led by Redalpine Venture Partners, underscores the accelerating convergence of consumer wearables and clinical-grade health monitoring. With Fitbit’s competing FDA clearance and UnitedHealthcare’s new reimbursement policy for AI preventive tools, Hilo’s optical blood pressure technology faces both validation and intensified competition in the rapidly evolving healthtech landscape.
Regulatory milestones and funding surge
Hilo (formerly Aktiia) announced its $30M Series B funding on June 18, 2024, led by Redalpine Venture Partners, valuing the company at $280M post-money according to TechCrunch. This capital injection accelerates the company’s FDA De Novo submission for its optical blood pressure monitoring algorithm, which already holds CE marking in Europe.
The funding comes just days before Fitbit received FDA clearance on June 19 for similar optical blood pressure technology, validating the technical approach while raising questions about differentiation in an increasingly crowded market. “The simultaneous regulatory progress across multiple players confirms the medical community’s acceptance of optical signal analysis for hypertension management,” noted Dr. Annette Phillips, a cardiologist at Johns Hopkins, in an interview with MedTech Dive.
Clinical validation and enterprise adoption
A June 17 study in JAMA Cardiology demonstrated Hilo’s algorithm achieves 93% correlation with invasive arterial measurements in hypertensive patients, based on training data from over 120,000 users. This clinical validation coincides with Hilo’s June 20 announcement of Epic EHR integration, positioning its technology for employer health programs and population health management.
Rock Health’s Q2 2024 report shows clinical AI solutions demonstrating 76% year-over-year revenue growth, with UnitedHealthcare’s June 21 policy change to reimburse FDA-cleared preventive tools creating new monetization pathways. “We’re seeing payer willingness to cover validated digital diagnostics that can scale preventive care,” observed Rock Health partner Megan Zweig in the report.
Historical context of wearable health monitoring
The current wave of optical blood pressure monitoring builds upon a decade of advancements in photoplethysmography (PPG) technology. Early wrist-worn devices like the 2014 Mio Alpha demonstrated basic heart rate monitoring, while the 2018 Apple Watch Series 4 introduced ECG capabilities that gained FDA clearance – setting important precedents for consumer wearables obtaining medical device classification.
This evolution mirrors the trajectory of continuous glucose monitors (CGMs), which transitioned from clinical tools to mainstream diabetes management devices. Dexcom’s G6 CGM received FDA clearance in 2018, followed by Abbott’s Freestyle Libre – establishing the regulatory and commercial blueprint that blood pressure monitoring wearables now follow. The key difference lies in hypertension’s asymptomatic nature, making accuracy benchmarks even more critical for preventive applications.
