Noah Labs
AI-powered telemonitoring and voice diagnostics for cardiovascular diseases.
Website: https://www.noah-labs.com/
Cover Block
PUBLIC
| Field | Value |
|---|---|
| Name | Noah Labs |
| Tagline | AI-powered telemonitoring and voice diagnostics for cardiovascular diseases |
| Headquarters | Berlin, Germany |
| Founded | 2021 |
| Stage | Seed |
| Business Model | B2B |
| Industry | Healthtech (Cardiovascular) |
| Technology Type | AI / Machine Learning, Class IIa Medical Device Software |
| Geography | Western Europe |
| Growth Profile | Venture Scale |
| Founding Team | Co-Founders (Oliver Piepenstock, Marcus Hott, Dr. Leonhard Riehle) |
| Funding Label | Seed |
| Total Disclosed | ~$4.29M equity plus ~$16.85M in disclosed grants |
Links
PUBLIC
- Website: https://www.noah-labs.com/
- LinkedIn: https://www.linkedin.com/company/noah-labs
- Crunchbase: https://www.crunchbase.com/organization/noah-labs
- PitchBook: https://pitchbook.com/profiles/company/494783-11
Executive Summary
PUBLIC
Noah Labs is a Berlin-based healthtech company building AI software that listens for the early acoustic signatures of worsening heart failure, an approach that just earned an FDA Breakthrough Device Designation in March 2026 [Noah Labs, March 2026]. Founded in 2021 by Oliver Piepenstock and Marcus Hott, with co-founder Dr. Leonhard Riehle, the company emerged from research that Hott conducted at Harvard Medical School on applying machine learning to cardiovascular signals [Noah Labs, retrieved 2026]. Its commercial product, Ark, is a Class IIa Medical Device Software that integrates external devices and implants for remote monitoring of chronic cardiovascular conditions; its diagnostic engine, NL Vox, infers cardiac decompensation from short voice samples recorded on a patient smartphone [Noah Labs, retrieved 2026]. The company has raised roughly $4.29M in equity across an angel round in November 2022 and a €3M seed in September 2024 led by specialist healthcare investor Nina Capital [Crunchbase, Nov 2022] [Vestbee, Sep 2024], complemented by sizeable non-dilutive grants from the EU, ILB (ProFIT), and EIT Health [LinkedIn, retrieved 2026]. Vox has reportedly been validated across five multicentre clinical trials with partners including the Mayo Clinic and UCSF [Medical Device Network, retrieved 2026], and the company is currently running the PRE-DETECT-HF study at Clinic Barcelona and University Medical Center Maastricht [Noah Labs, retrieved 2026]. Over the next 12 to 18 months, the items to watch are PRE-DETECT-HF readouts, FDA clearance progression following Breakthrough designation, and whether the Herz-Hirn-Allianz partnership with Novartis converts into a commercial pull-through channel.
Data Accuracy: GREEN -- Confirmed by Noah Labs press, Crunchbase, Vestbee, and Medical Device Network.
Taxonomy Snapshot
| Axis | Value |
|---|---|
| Stage | Seed |
| Business Model | B2B (medical device software, sold into providers and pharma partnerships) |
| Industry / Vertical | Healthtech, cardiovascular care |
| Technology Type | AI / deep learning on voice and multiparametric vitals |
| Geography | Western Europe (HQ Berlin); clinical footprint in Spain, Netherlands, US |
| Growth Profile | Venture Scale |
| Founding Team | Three co-founders, mixed clinical-research and operator backgrounds |
| Funding | ~$4.29M equity disclosed, plus ~$16.85M disclosed grants |
Company Overview
PUBLIC
Noah Labs was founded in Berlin in 2021 by Oliver Piepenstock and Marcus Hott, with Dr. Leonhard Riehle as a co-founder, around the thesis that voice carries detectable physiological signal that can flag cardiac deterioration before clinical symptoms force a hospitalization [Noah Labs, retrieved 2026]. Hott had previously worked as an AI programmer at Harvard Medical School, which the company cites as the intellectual origin of its cardiovascular AI work [Noah Labs, retrieved 2026]. Piepenstock, trained as a financial economist at Copenhagen Business School, had earlier founded the elder-care platform Mecasa before moving into medical device software [ahahealthtech.org, retrieved 2026] [F6S, retrieved 2026].
The company's milestone arc is unusually regulatory-heavy for a seed-stage startup. After joining the Berlin Startup Stipend Health track shortly after founding [Noah Labs, retrieved 2026], Noah Labs closed an angel round of roughly $988K in November 2022 [Crunchbase, Nov 2022], earned ISO 13485 certification as a medical device manufacturer [Noah Labs, retrieved 2026], and obtained Class IIa medical device approval for its Ark platform [Noah Labs, retrieved 2026]. In September 2024 it announced a €3M seed round led by Nina Capital with participation from adesso ventures and the DHZB Foundation [Vestbee, Sep 2024], alongside European Regional Development Fund and State of Brandenburg support for its Pre-Sense multiparametric application [Noah Labs, retrieved 2026].
More recently, the company was selected for the EIC Accelerator program [Noah Labs, retrieved 2026], joined the Novartis-led Herz-Hirn-Allianz as its first startup signatory targeting a 30 percent reduction in cardiovascular events by 2030 [Noah Labs, retrieved 2026], and in March 2026 obtained FDA Breakthrough Device Designation for Noah Labs Vox, a status that expedites clearance review and commercial activities in the United States [Noah Labs, March 2026].
Data Accuracy: GREEN -- Confirmed by Noah Labs press, Crunchbase, Vestbee, and PitchBook.
Product and Technology
MIXED
Noah Labs ships two related products. Ark [PUBLIC] is a Class IIa Medical Device Software under EU MDR that handles telemonitoring for chronic cardiovascular conditions, including heart failure, hypertension, and arrhythmia, by ingesting real-time vital data from approved medical devices and implants and surfacing it to clinicians [Noah Labs, retrieved 2026]. NL Vox [PUBLIC] is the AI layer: deep learning models trained on proprietary datasets of audio recordings that detect impending cardiac decompensation from short voice samples captured on a patient smartphone, with the clinical aim of intervening before hospitalization [Noah Labs, retrieved 2026]. Together they form a pairing where Ark is the regulated workflow rail and Vox is the differentiated diagnostic signal.
Clinical validation is the area where the company has invested most visibly. Vox has reportedly been validated across five multicentre clinical trials, with partners including the Mayo Clinic and the University of California San Francisco [Medical Device Network, retrieved 2026], and a Forbes reference describes a Mayo Clinic collaboration on cardiovascular AI diagnostics [Forbes, retrieved 2026]. The active PRE-DETECT-HF trial, funded in part by EIT Health, is running at Clinic Barcelona and University Medical Center Maastricht for early detection of heart failure decompensation [Noah Labs, retrieved 2026]. On the regulatory side, the combination of ISO 13485, Class IIa approval, and the March 2026 FDA Breakthrough Device Designation gives Vox an unusually mature compliance posture for a company at this funding stage [Noah Labs, March 2026].
The technology stack beyond "deep learning on proprietary audio datasets" is not described in detail in public materials, and the company's own statements emphasise the dataset rather than the model architecture as the source of edge. The differentiation rests on the proprietary acoustic dataset and the integrated regulated workflow rather than on a novel model layer.
Data Accuracy: GREEN -- Confirmed by Noah Labs product pages, Medical Device Network, and Noah Labs regulatory press.
Market Research and Opportunity
PUBLIC
Heart failure is one of the most expensive chronic conditions in the developed world, and the cost driver is rehospitalization, which is exactly the event Noah Labs is trying to push upstream. Worsening heart failure is typically detected days or weeks too late, after fluid overload has already triggered an emergency admission, and any tool that creates earlier warning has a direct line to reducing the most costly element of cardiovascular care.
The demand drivers cited in Noah Labs' own materials and partner communications point to three converging tailwinds. First, payer and provider pressure on heart failure readmissions, which in many European systems and the US Medicare program carry direct financial penalties, creates an addressable budget for remote monitoring tools that can demonstrate avoided admissions. Second, regulatory infrastructure for software-as-a-medical-device has matured under EU MDR, which is why Ark could obtain Class IIa status, and the FDA's Breakthrough Device pathway, which Vox now sits within [Noah Labs, March 2026], is explicitly designed to accelerate review of devices addressing serious conditions. Third, pharma engagement: the Novartis-initiated Herz-Hirn-Allianz, which Noah Labs joined as the first startup signatory, has set an explicit target of reducing cardiovascular events by 30 percent by 2030 [Noah Labs, retrieved 2026], aligning a major drug company's commercial incentive with a startup's monitoring tool.
Adjacent and substitute markets matter for sizing the realistic wedge. Implant-based monitoring (CardioMEMS and similar pulmonary artery pressure sensors) competes for the highest-acuity heart failure population, while wearables and connected scales compete for the lower-acuity, longitudinal monitoring layer. Voice-based inference is, in principle, deployable across both bands at near-zero hardware cost, which is the structural argument for why an audio approach could expand the monitored population rather than simply replace existing tools. Macro and regulatory forces on the risk side include the EU AI Act, which classifies medical AI as high-risk and imposes additional documentation and post-market surveillance obligations, and reimbursement uncertainty, since DiGA-style fast-track reimbursement in Germany has been a moving target for digital therapeutics and monitoring tools.
No third-party TAM figure for AI voice diagnostics in cardiology is available in the cited research, and rather than pad the section with an unrelated number we note that explicitly. The honest analyst takeaway: the market wedge is real and policy-supported, but the dollar-sized prize will be defined by reimbursement codes that do not yet exist for voice-based cardiac monitoring specifically, and by whether PRE-DETECT-HF and the Mayo and UCSF collaborations produce evidence strong enough to compel coverage decisions.
Data Accuracy: YELLOW -- Demand drivers and regulatory framing confirmed by Noah Labs press and program announcements; no third-party TAM figure available in cited sources.
Competitive Landscape
MIXED
Noah Labs sits at the intersection of three competitive bands: implantable hemodynamic monitors at the high-acuity end, smartphone- and wearable-based heart failure monitoring platforms in the middle, and emerging voice-biomarker companies at the diagnostic-signal layer. The structured facts contain no named competitors, so the comparison here is qualitative rather than tabular.
In the implant-based segment, the dominant reference point is Abbott's CardioMEMS pulmonary artery pressure sensor, which has the deepest evidence base for reducing heart failure hospitalizations but requires an invasive procedure and targets a relatively narrow severe-NYHA-Class-III population. Noah Labs does not compete head-on here; rather, Vox and Ark address the much larger upstream cohort that never qualifies for an implant. The competitive risk in this band is not displacement but reimbursement gravity: payers familiar with funding implant-based monitoring may be slow to reimburse a software-only signal until trial evidence is comparable in rigor.
In the digital monitoring band, the field includes a long list of European and US heart failure remote monitoring platforms built around connected scales, blood pressure cuffs, and patient-reported outcomes, often paired with care-team workflows. Noah Labs' Ark product sits squarely in this segment, and the differentiation argument leans on Vox: a passive, smartphone-only signal that does not require additional peripherals and that, if validated, would offer earlier warning than weight-based fluid overload detection. The defensible edge today is the proprietary audio dataset and the regulatory stack (ISO 13485, Class IIa, FDA Breakthrough), all of which are slow and expensive to replicate. The perishable part of that edge is the dataset itself: voice models from large foundation-model labs and academic groups are improving quickly, and a well-funded entrant with access to a large clinical audio corpus could close the gap on the model side. The moat therefore needs to be reinforced by clinical evidence and embedded distribution before generalist AI catches up.
In the voice-biomarker layer, several startups (Kintsugi in mental health, Canary Speech in cognitive and behavioral health, and historically Beyond Verbal and earlier Mayo Clinic voice-cardiac research) have pursued acoustic biomarkers for various conditions. Noah Labs' specific bet on cardiac decompensation, paired with a regulated telemonitoring product rather than a pure API, is a narrower and more clinically defensible scope than horizontal voice-AI plays. Where Noah Labs is most exposed is in the US commercial channel: it has no disclosed US sales presence, and a domestic competitor with similar evidence and existing payer relationships could win category-defining contracts before Noah Labs completes FDA clearance.
The most plausible 18-month scenario: the winner if PRE-DETECT-HF produces clean positive readouts and FDA clearance follows on the heels of the Breakthrough designation is Noah Labs itself, because the combined Ark plus Vox bundle then becomes uniquely positioned for both EU MDR and US deployment with pharma-aligned distribution via Herz-Hirn-Allianz. The loser if a US-based voice-cardiac competitor secures a parallel FDA clearance with a Medicare-billable code first is Noah Labs' US growth path, which would then default to a partnership or licensing route rather than direct commercial scale.
Data Accuracy: ORANGE -- Subject company facts confirmed; competitor framing inferred from category knowledge as no competitors are named in cited sources.
Opportunity
PUBLIC
If Noah Labs executes, the size of the prize is becoming the default voice-based early-warning layer for heart failure across European and US health systems, sitting inside both provider workflows and pharma-funded outcomes programs.
The headline opportunity. The single largest plausible outcome is that Vox becomes the standard-of-care passive monitoring signal for heart failure decompensation, paired with Ark as the regulated workflow rail. The cited evidence makes this reachable rather than aspirational for three reasons: the FDA Breakthrough Device Designation explicitly compresses the US clearance timeline [Noah Labs, March 2026]; Class IIa approval and ISO 13485 certification mean European deployment is not gated by a multi-year regulatory build [Noah Labs, retrieved 2026]; and the Novartis-initiated Herz-Hirn-Allianz gives the company a pre-built distribution conversation with one of the largest cardiovascular pharma franchises [Noah Labs, retrieved 2026]. A startup with this combination of regulatory, clinical, and pharma-channel positioning at the seed stage is uncommon.
Growth scenarios.
| Scenario | What happens | Catalyst | Why it's plausible |
|---|---|---|---|
| Pharma-embedded standard | Vox becomes the monitoring layer attached to Novartis and peer cardiovascular drug programs as part of outcomes-based contracting | Conversion of Herz-Hirn-Allianz signatory status into a paid integration with at least one branded heart failure therapy [Noah Labs, retrieved 2026] | Pharma is actively looking for digital adherence and outcomes evidence to defend pricing on chronic cardiovascular drugs |
| US payer wedge | Following FDA clearance, Vox secures a CPT or remote physiologic monitoring code and rides Medicare reimbursement into US health systems | FDA clearance built on Breakthrough Designation pathway [Noah Labs, March 2026] plus Mayo and UCSF validation evidence [Medical Device Network, retrieved 2026] | RPM reimbursement infrastructure already exists in the US and has been used by adjacent monitoring platforms |
| EU public health rollout | Vox plus Ark is procured by national or regional payers as a heart failure readmission reduction tool | Positive PRE-DETECT-HF readout from Clinic Barcelona and Maastricht [Noah Labs, retrieved 2026] combined with EIC Accelerator commercialization support [Noah Labs, retrieved 2026] | EU health systems carry direct fiscal exposure to heart failure readmissions and have funded comparable digital interventions |
What compounding looks like. The flywheel is data-driven. Each clinical deployment produces additional labelled voice recordings paired with outcome data, which improves Vox's sensitivity and specificity, which strengthens the next regulatory submission and the next payer conversation, which expands deployment. The proprietary dataset, already cited as the training base for the deep learning models [Noah Labs, retrieved 2026], is the asset that compounds; the regulatory stack (ISO 13485, Class IIa, FDA Breakthrough) is the moat that prevents a generalist AI lab from short-circuiting the loop without years of catch-up work. There is early evidence the flywheel is starting: five multicentre trials reported with Mayo and UCSF among the partners [Medical Device Network, retrieved 2026] is a larger evidence base than most seed-stage diagnostic AI companies have assembled.
The size of the win. No directly comparable public market cap exists for a voice-based cardiac diagnostic, so any number here is a scenario rather than a forecast. As a reference point, remote cardiac monitoring acquisitions and category leaders have historically commanded valuations in the high hundreds of millions to low billions of dollars at maturity, and pharma-aligned digital health platforms with outcomes-based contracts have secured premium multiples when they reach defensible reimbursement positions. If Noah Labs reaches the pharma-embedded standard scenario above with even one major cardiovascular franchise, the reasonable upper-bound outcome is a category-defining exit at the high end of that range (scenario, not a forecast). The downside reference point is that pre-revenue medical device software companies typically trade on milestones rather than financials, meaning value accretion will be lumpy and tied directly to the trial readouts and clearances flagged earlier.
Data Accuracy: YELLOW -- Strategic framing built on confirmed regulatory and partnership facts; scenario sizing is illustrative and explicitly labelled as such.
Sources
PUBLIC
[Noah Labs, retrieved 2026] Noah Labs homepage | https://www.noah-labs.com/
[Noah Labs, retrieved 2026] About Us | https://www.noah-labs.com/about-us
[Noah Labs, retrieved 2026] NL Vox product page | https://www.noah-labs.com/nl-vox
[Noah Labs, retrieved 2026] NL Ark product page | https://www.noah-labs.com/nl-ark
[Noah Labs, March 2026] News Room and FDA Breakthrough Device Designation announcement | https://www.noah-labs.com/news-room
[Noah Labs, retrieved 2026] Noah Labs selected for EIC Accelerator program | https://www.noah-labs.com/blog/noah-labs-selected-for-highly-competitive-eic-accelerator-program
[Noah Labs, retrieved 2026] Noah Labs receives ISO 13485 certification | https://www.noah-labs.com/blog/noah-labs-receives-iso-certification
[Noah Labs, retrieved 2026] Noah Labs welcomed as first startup at Herz-Hirn-Allianz initiated by Novartis | https://www.noah-labs.com/blog/noah-labs-welcomed-as-first-startup-at-herz-hirn-allianz-initiated-by-novartis
[Noah Labs, retrieved 2026] Noah Labs receives funding from the EU and the State of Brandenburg | https://www.noah-labs.com/blog/noah-labs-receives-funding-from-the-eu-and-the-state-of-brandenburg
[Noah Labs, retrieved 2026] Noah Labs selected for Berlin Startup Stipend Health track | https://www.noah-labs.com/blog/noah-labs-selected-for-berlin-startup-stipend-bss-health-track
[Vestbee, Sep 2024] Berlin-based healthtech startup Noah Labs secures EUR 3M led by Nina Capital | https://www.vestbee.com/insights/articles/noah-labs-secures-3-m
[Crunchbase, retrieved 2026] Noah Labs company profile | https://www.crunchbase.com/organization/noah-labs
[Crunchbase, Nov 2022] Angel Round - Noah Labs - 2022-11-01 | https://www.crunchbase.com/funding_round/noah-labs-angel--92700bed
[Crunchbase, Sep 2024] Seed Round - Noah Labs - 2024-09-19 | https://www.crunchbase.com/funding_round/noah-labs-pre-seed--ab24b480
[PitchBook, retrieved 2026] Noah Labs 2026 Company Profile | https://pitchbook.com/profiles/company/494783-11
[LinkedIn, retrieved 2026] Noah Labs LinkedIn company page | https://www.linkedin.com/company/noah-labs
[Startup Valley, retrieved 2026] Noah Labs Ark verbindet Patienten | https://startupvalley.news/de/noah-labs/
[Medical Device Network, retrieved 2026] Coverage of Vox multicentre clinical validation with Mayo Clinic and UCSF | https://www.medicaldevice-network.com/
[Forbes, retrieved 2026] Coverage of Noah Labs and Mayo Clinic cardiovascular AI collaboration | https://www.forbes.com/
[ahahealthtech.org, retrieved 2026] Oliver Piepenstock biographical reference | https://ahahealthtech.org/
[F6S, retrieved 2026] Oliver Piepenstock founder profile | https://www.f6s.com/
Articles about Noah Labs
- Noah Labs Wants to Hear Heart Failure Coming Weeks Before the Ambulance — The Berlin startup's voice algorithm just earned an FDA Breakthrough tag, with trials running in Barcelona and Maastricht.