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Vol. 4 · No. 38

DIGEST

Today's Lead Story · FDA & Regulatory

FDA Clears First AI-Assisted Sepsis Prediction System for ICU Deployment — What It Means for Your Health System

De novo authorization sets a precedent for real-time clinical decision support at the point of care. Three health systems are already in contract discussions.

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Today's EditionThree stories. Read before rounds.
FDA & Regulatory

FDA Clears AI Sepsis Predictor: The De Novo Pathway Just Got a Template

Cognify Health's SepsisAlert 2.0 receives 510(k) clearance after 14-month review — the fastest AI-device approval since the 2023 predicate expansion.

The clearance, announced Tuesday at 6:14 AM ET, applies to adult ICU patients in health systems running Epic or Oracle Health EHRs. The algorithm flags deterioration risk 6 hours before clinical presentation with 84% sensitivity and a false-positive rate that regulators deemed "operationally acceptable" for a decision-support — not decision-making — classification.

For health system CTOs, the operative word is integration. The FDA's special controls memo explicitly requires that SepsisAlert surface alerts within the clinician's existing workflow rather than a standalone interface. That's a procurement signal: any competing vendor without native EHR hooks will face the same regulatory friction.

"The 6-hour prediction window is the clinical threshold that makes this actionable — not just informative."

Dr. Marcus Webb, Contributing Editor

Source: FDA 510(k) Database K253847 · ClinicalTrials.gov NCT05891234

Series B Watch

Aurelius Genomics Closes $94M Series B to Scale Pharmacogenomics at Point of Care

The round, led by GV with participation from Andreessen Bio and Mayo Clinic Ventures, funds a 40-hospital commercial expansion and a direct-to-lab API.

Aurelius's pitch is straightforward: 7% of adverse drug events are attributable to variants that a $29 genotype test would catch. The company has 12 health system contracts — 9 signed in the past 18 months — and claims a 340-day average time-to-contract, which is aggressively fast for enterprise health IT.

The Series B values Aurelius at approximately $410M post-money, according to sources familiar with the terms. That's a 2.8x step-up from the $147M Series A valuation in early 2024, reflecting both revenue growth (ARR reportedly crossed $18M in Q3) and the broader re-rating of genomics-adjacent companies following UnitedHealth's acquisition of Genomic Life.

"340-day average time-to-contract in enterprise health IT is either exceptional or anomalous. We're watching Q1 cohort retention."

Priya Sundaram, Venture Desk

Source: SEC Form D · Crunchbase · Company Press Release

Clinical Trials

NAVIGATE-HF Phase III Readout: Digital Therapeutics Arm Shows 23% Reduction in 30-Day Readmission

The Cardiolink DTx app, deployed post-discharge, hit its primary endpoint in 1,847 patients across 22 sites. A PMA submission is expected by Q2.

NAVIGATE-HF is the largest randomized controlled trial of a digital therapeutic in heart failure management. The 23% reduction in 30-day readmission (p=0.003, NNT=14) is a number that hospital finance teams will translate immediately: at a $12,000 average readmission cost, NNT 14 implies roughly $170,000 in avoidable cost per 200 enrolled patients annually.

The secondary endpoints are more nuanced. Patient-reported outcomes on the Kansas City Cardiomyopathy Questionnaire improved by 8.2 points — above the minimal clinically important difference of 5 points but below the 12-point threshold that cardiology opinion leaders consider "meaningful." The biotech founder community will note that Cardiolink's prescription DTx model requires physician initiation, a workflow friction that consumer-first competitors have deliberately avoided. Cardiolink's CEO confirmed on a press call that the company is in active discussions with CMS regarding a New Technology Add-On Payment designation, which could accelerate hospital adoption before commercial reimbursement pathways are established.

"NNT of 14 is the cardiology equivalent of a blockbuster. The question is who pays for it first — the payer or the health system."

Jonathan Okafor, Clinical Desk

Source: NAVIGATE-HF Trial · NEJM Evidence Preprint · ClinicalTrials.gov NCT05234891

FDA · SepsisAlert 2.0 ClearedAurelius Genomics · $94M Series BNAVIGATE-HF · Phase III PositiveCMS · NTAP Application Window Opens March 1Digital Health Funding Q4 2025 · $3.2BFDA · SepsisAlert 2.0 ClearedAurelius Genomics · $94M Series BNAVIGATE-HF · Phase III PositiveCMS · NTAP Application Window Opens March 1Digital Health Funding Q4 2025 · $3.2BFDA · SepsisAlert 2.0 ClearedAurelius Genomics · $94M Series BNAVIGATE-HF · Phase III PositiveCMS · NTAP Application Window Opens March 1Digital Health Funding Q4 2025 · $3.2B
Data Interlude · Funding Pulse

Digital Health Funding,
Q1 2022 – Q4 2025

After the 2022–23 correction erased $2B per quarter in deal flow, investment has recovered to pre-correction levels — with a sharper concentration in AI-enabled clinical tools and genomics infrastructure.

Total Funding ($B)
Area = Deal Volume
Correction Period

Q4 2025 Total

$4.7B

↓ 7.8% QoQ

YTD 2025 Deals

410

AI-enabled: 61%

Median Series B

$62M

↑ from $44M in 2024

Top Segment

Clinical AI

$1.9B YTD

Research Report

Download the 2025 HealthTech Funding Report

48 pages. Sector breakdowns, deal comps, and the 12 companies to watch in 2026.

Pipeline Watch

Clinical Trials & Regulatory Tracker

CompanyProduct / IndicationPhasePrimary EndpointReadoutStatusSignal
CardiolinkCardioGuide DTxHeart Failure (Post-Discharge)Phase III30-day readmissionFeb 18, 2026
Reported
▲ Positive
Neuraxis AINeuroPredictEarly Alzheimer's DetectionPhase II/IIIBiomarker concordanceMar 12, 2026
Readout Imminent
◉ Watch
Luminary GenomicsLumPGx PanelOncology PharmacogenomicsPhase IIIAdverse event reductionApr 3, 2026
Enrolling
— Neutral
Synthex BioSYN-401NASH / Metabolic Liver DiseasePhase IILiver stiffness (MRE)Q2 2026
Enrolling
◉ Watch
Orbis HealthRetinaScan AIDiabetic Retinopathy (Primary Care)De Novo (FDA)Sensitivity / SpecificityUnder Review
Readout Imminent
▲ Positive
Veridian DxVDX-SepsisSepsis Early WarningPhase IIITime-to-antibioticsJun 2026
Enrolling
— Neutral
PulsePointRemoteCare 3.0Remote Patient Monitoring — CHFPhase IV / RWEHospitalization rateQ3 2026
Enrolling
— Neutral
Helix NeuroHLX-300Treatment-Resistant DepressionPhase IIMADRS score at 8wkOn Clinical Hold
Clinical Hold
◉ Watch

Data sourced from ClinicalTrials.gov, company press releases, and FDA CDER database. Last updated: May 29, 2026.

Full Pipeline Database →
Opinion · The Editors

The Hospital CTO's Dilemma: Buy the Platform, or Build the Moat?

As health AI vendors consolidate and EHR giants expand their AI offerings, the strategic question is no longer "which point solution?" but "which platform bet?"

Three years ago, a hospital CTO could evaluate AI tools in isolation. Sepsis prediction here. Radiology triage there. The procurement model was familiar: RFP, pilot, contract, integrate. The integration was the hard part, but it was a known hard part.

That era is ending. Epic's AI-native features, Oracle Health's Clinical AI, and Microsoft Nuance's ambient documentation have collapsed what was once a rich ecosystem of point solutions into a binary choice: bet on your EHR vendor's AI roadmap, or build a parallel infrastructure layer that will require perpetual maintenance.

"The health systems that will win are not the ones with the most AI vendors — they're the ones that decided which platform owned the workflow and built everything else around it."

— Dr. Ananya Krishnan, Chief Innovation Officer, Midwest Academic Medical Center

The Aurelius Genomics round announced this week is instructive. Their 340-day average sales cycle — remarkable by enterprise health IT standards — is partly a product of selling into innovation officers who have already made the platform bet and are now selectively layering complements. The genomics use case is narrow enough to avoid threatening the EHR vendor, and valuable enough to justify a standalone budget line.

The harder question is what happens to the companies selling adjacent to the core workflow. Remote patient monitoring. Clinical decision support. Prior authorization automation. These are exactly the spaces where Epic, Oracle, and Microsoft are expanding. The window for independent category leaders may be narrower than the funding data suggests.

The Editors · Digest · Vol. 4, No. 38Continue Reading →
Regulatory Calendar
Mar 1

CMS NTAP Application Window Opens

CMS
Mar 7

FDA Advisory Committee: AI-Enabled Diagnostics

FDA
Mar 14

HIMSS 2026 Annual Conference Begins

Conference
Mar 21

ONC HTI-2 Rule Comment Period Closes

ONC
Apr 1

New CPT Codes for Remote Monitoring Effective

CMS
Apr 15

FDA PDUFA Goal Date: Cognify SepsisAlert 3.0

FDA
May 3

Digital Medicine Society Annual Summit

Conference

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