Noah Labs' EIC Accelerator AI Hears Heart Failure in the Voice

When heart failure worsens, fluid collects in the lungs and the vocal folds, and the voice changes. Noah Labs, a Berlin company founded in 2021, trains deep learning models to hear those changes in a short voice recording and to warn clinicians before a patient has to be admitted to hospital, according to its product page. Its first product, the remote monitoring platform Ark, is already certified in the EU; the voice algorithm, Vox, is still in clinical validation.

The EIC Accelerator selected the project, NL Vox, at its October 2024 cut-off for blended finance, and CORDIS records a grant of €2,487,135 from May 2025 to April 2027 to improve the AI model, win regulatory approval, integrate with telemonitoring devices and add explainable AI. In 2026 Vox received FDA Breakthrough Device Designation, and a German study found it detected 21 of 25 heart failure hospitalisations.

From Ark to Vox

Noah Labs started with Ark, software that collects data from smartwatches, ECGs and blood pressure monitors and alerts doctors to changes in heart failure, hypertension and arrhythmia patients. Ark was approved as a Class IIa medical device under the EU Medical Device Regulation in April 2024. In September 2024 the company closed a €3 million seed round led by Nina Capital, with adesso ventures, the Foundation of the German Heart Center Berlin, a grant and loan from the Brandenburg investment bank's ProFIT programme and business angels, Health Capital Berlin-Brandenburg reported.

The voice work was already running. A €1.5 million EIT Health grant funds PRE-DETECT-HF, a trial that started in January 2024 and that Noah Labs says is meant to validate the algorithm for MDR approval. The company says it has more than three million voice samples and has tested the algorithm with Mayo Clinic, UCSF, Charité Berlin, Maastricht University Medical Center and Hospital Clínic de Barcelona.

TIM-HF3: voice against the scales

The strongest data so far comes from TIM-HF3, a prospective study at three German centres presented as late-breaking science at Heart Failure 2026, the congress of the European Society of Cardiology's heart failure association, according to the company's release. 105 patients with chronic heart failure recorded a sustained vowel on a tablet once a week while also sending daily weight, blood pressure and ECG data to a telemedicine centre.

The voice algorithm detected 21 of 25 heart failure hospitalisations, a sensitivity of 84%, with a median 29 days between alert and event and 2.62 unexplained alerts per patient-year. Daily weight alerts on the same events caught 9, a sensitivity of 36%, with a median 13 days of warning and 6.07 unexplained alerts per patient-year. The voice part was observational: no doctor acted on the alerts. Noah Labs developed the algorithm and ran the voice analysis, while the trial itself was funded by the German economy ministry. Principal investigator Friedrich Köhler said the next step is an interventional trial to test "whether this earlier warning translates into fewer hospitalizations".

NL Vox and the regulators

In March 2026 the FDA granted Vox Breakthrough Device Designation, which speeds up review, and Noah Labs said an FDA trial was set to start shortly, according to its press release. The release describes a five-second daily voice clip and no extra hardware. In Europe, the company's product page still lists Vox as in clinical validation and PRE-DETECT-HF as ongoing, and no CE mark for Vox has been announced. CORDIS shows no periodic report for the EIC project yet.

1. Improved AI modelTested84% sensitivity in TIM-HF3, May 2026.
2. US regulatory pathDesignatedFDA Breakthrough Device Designation, March 2026; no clearance.
3. EU market approvalNot yetVox listed as in clinical validation.
4. Fewer hospitalisationsNot testedInterventional trial still to come.

Grants first

The EIC award offered up to €11 million: the €2.5 million grant and up to €8.5 million in potential equity from the EIC Fund, the company said when it was selected in May 2025. No EIC Fund investment has been announced since. In March 2026 Noah Labs put its combined public grant and private equity funding at $12 million; the largest disclosed parts are the seed round, the EIC grant and the EIT Health grant. Its German accounts were not obtained for this article.

A European biomarker heading to the US

The research behind Vox is largely European, from the Charité's German Heart Center to the TIM-HF3 centres and the EU-funded PRE-DETECT-HF trial, and the EIC grant pays for the step to approval. The first regulatory milestone came from the FDA, and Noah Labs now presents itself as a Boston- and Berlin-based company, with an FDA trial announced and, as its newsroom lists, places in the HeartX cohort and MedTech Innovator in 2026.