Hyfe
by Hyfe
· Based in United States →
— Making Cough Count: Establishing cough as a routinely measured biomarker and endpoint to advance clinical research and transform respiratory care.
Documentation Provided
Overview
Hyfe is an AI-powered acoustic monitoring system designed to detect and analyze coughs. It aims to establish cough as a measurable biomarker for respiratory health.
- What it does: Hyfe’s technology uses artificial intelligence to continuously detect and timestamp cough events in real-world settings. The AI models run on-device, processing audio locally and transmitting only metadata (timestamps), ensuring privacy by not recording or storing conversations or audio.
- Who it is for: Hyfe is utilized by researchers, pharmaceutical companies, and healthcare providers. It is relevant for specialties involved in respiratory conditions such as chronic cough, COPD, asthma, and other ailments where cough is a significant symptom. Care settings include clinical trials, remote patient monitoring programs, and telehealth platforms.
- How it fits a clinical or practice workflow: For clinical trials, Hyfe’s CoughMonitor Suite provides continuous, objective cough frequency data as an endpoint or for screening and adherence monitoring. In practice, it can integrate with remote patient monitoring and hospital-at-home systems to offer physicians a more informed picture of patients’ cough patterns, potentially aiding in earlier exacerbation identification and informing treatment plans.
- Notable capabilities: Key features include continuous, long-term cough monitoring (days, weeks, or months), on-device AI processing for privacy, and a validated accuracy in detecting coughs. The system can run on various microphone-enabled devices, including wearables and smartphones.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Acoustic AI cough detection
- Continuous cough monitoring
- Clinically validated platform
- Privacy-first (on-device processing)
- Scalable for research and healthcare
- Ultra-lightweight footprint
- Cross-platform architecture
- Generalizable acoustic model
- Validated accuracy
- APIs and SDKs for integration
Use Cases
- Clinical trials and drug development
- Digital therapeutics for cough hypersensitivity
- Individual cough tracking and management
- Respiratory health research
- Cough insights for healthcare organizations
- Objective measurement of cough as a biomarker
What Physicians Need to Know
Clinical Trial Matching
Hyfe's AI-powered cough monitoring is extensively used in drug development and clinical trials. It aids in patient recruitment by identifying individuals who cough via global consumer apps and in patient selection by screening for high and stable baseline cough rates to reduce the placebo effect.
Real-World Evidence Analysis
Hyfe provides objective, continuous cough monitoring in real-world settings, transforming cough from a subjective symptom into a quantifiable digital biomarker. This allows for continuous tracking over extended periods (days, weeks, or months), revealing valuable insights into longitudinal cough patterns. The system quantifies cough frequency and patterns in real-world conditions with high participant adherence, producing clinically interpretable and operationally practical data at scale.
Safety Signal Detection
While Hyfe's primary focus is cough detection, the continuous, objective monitoring of cough frequency can serve as an important efficacy endpoint in FDA-reviewed chronic cough programs. This type of objective data can contribute to a broader understanding of a drug's impact on respiratory symptoms, which could indirectly support safety signal detection by providing clearer data on symptom changes. AI-powered pharmacovigilance, in general, utilizes AI to automate data extraction and enhance signal detection from diverse real-world data sources.
Collaboration Features
Hyfe's technology powers clinical trial endpoints for pharmaceutical companies and medical device manufacturers, and supports innovative research at academic institutions and healthcare organizations worldwide. They offer various models for engagement, including monitoring as a service, licensed deployment within sponsor-led clinical trials, strategic partnerships for integration into broader therapeutic or device strategies, and embedding within third-party digital health or wearable platforms. Hyfe has partnered with ActiGraph to integrate its AI-powered cough detection into ActiGraph's wearable sensor devices for clinical trial data collection.
Publication Support
Hyfe's R&D team actively publishes peer-reviewed studies, white papers, and scientific conference abstracts related to cough monitoring, cough as a biomarker, acoustic epidemiology, and healthcare innovation. Their studies have been published in journals like BMJ Open Respiratory Research and F1000Research, and data is often made publicly available on platforms like GitHub.
Physician Tip
Hyfe's continuous, objective cough monitoring offers a significant advancement over traditional subjective or episodic assessments. Physicians can leverage this technology in clinical trials to gain a more accurate and comprehensive understanding of cough patterns and treatment efficacy in respiratory conditions. The privacy-preserving, on-device AI ensures patient data security, making it a reliable tool for long-term monitoring. Consider integrating Hyfe's data into patient management for conditions where cough is a key indicator, such as chronic cough, asthma, COPD, and heart failure, to inform personalized treatment strategies and objectively track disease progression.
Hyfe's AI cough detection models are designed with a cross-platform architecture, running seamlessly from on-device (edge) to cloud, enabling continuous monitoring on various hardware, including smartphones and wearables. The system provides structured, time-stamped outputs that can be transferred into Electronic Data Capture (EDC) systems, aligned with eCOA timestamps, or integrated into centralized data repositories. Hyfe offers APIs and SDKs for flexible integration into digital health ecosystems. Notably, Hyfe's Acoustic AI technology is integrated into the FDA-cleared ActiGraph LEAPu2122 wearable for comprehensive data collection in clinical trials.
Details
| Category | Drug Discovery & Research, Lab & Diagnostics, Telehealth & Virtual Care |
| Pricing | Unknown — unknown |
| Deployment | On-device (edge) to cloud, cross-platform (smartphones, wearables, clinical devices) |
| Mobile App | Yes (CoughPro, ResolveDTx) |
| API Available | Unknown |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated Hyfe's CoughMonitor Suite will serve as a primary endpoint in a pivotal clinical trial for a digital therapeutic to treat chronic cough, marking a precedent for objective digital endpoints in regulated drug and device development. |
| Integrations | |
| EHR | Not specified |
| Specialties | Allergy & Immunology, Pulmonology, Sleep Medicine |
Social Proof
| Customers | unknown |
| Notable | Pharmaceutical companiesmedical device manufacturersacademic institutionshealthcare organizations worldwide. |
What the Web Says
Hyfe is a company that utilizes acoustic AI to detect, track, and classify coughs, aiming to transform cough from a subjective symptom into a quantifiable digital biomarker. Their technology is used by researchers, medical professionals, and patients globally, with applications in clinical trials, disease management, and digital therapeutics for chronic cough. Hyfe emphasizes privacy by processing cough data on-device and only recording text-based timestamps, never actual audio.
Overall: PositiveStrengths
- Provides objective and continuous cough data, addressing the unreliability of patient self-reported cough information.
- High accuracy in cough detection (95%+ sensitivity and <1 false positive per hour, with some studies claiming 99% accuracy).
- Device-agnostic and integrates seamlessly into existing remote patient monitoring systems, working on various mic-enabled devices like smartphones and wearables.
- Privacy-preserving design, as it only records timestamps of coughs and no audio, ensuring patient confidentiality.
- Potential to shorten time to diagnosis, reduce hospital readmissions, and improve overall health outcomes by identifying exacerbations early.
- Validated through numerous clinical studies and peer-reviewed publications, demonstrating its effectiveness and reliability.
Limitations
- Some Reddit discussions about AI in healthcare express general distrust in AI for managing real health conditions due to concerns about hallucination or incorrect answers.
- One review on Reddit for AI medical scribes (not specifically Hyfe) mentioned slow feature additions and a lack of flexibility or custom templates, which could be a general concern for AI health tech.
- An older review (2019) for 'HFE' (not confirmed to be Hyfe.ai) on Indeed mentioned archaic IT systems and a reluctance for innovation, which might indicate potential challenges in some healthcare IT environments.
- A review of 'Hyfe.tech' (not confirmed to be Hyfe.ai) indicated insufficient information regarding safety for children or fraudulent activity, though it was described as 'legit'.
- General 'hype' around AI in some Reddit discussions suggests a potential for overestimation of the technology's current capabilities.
- No specific negative reviews from physicians, healthcare IT, tech reviewers, G2, or Capterra directly addressing Hyfe.ai's cough monitoring technology were found in the search results.
Based on reviews from: Hyfe.ai, Easy Counter, SPRIM Global Investments, Edge Impulse, G2, BioWorld, PubMed Central, Authority Magazine, Medical Product Outsourcing, Reddit
Last updated: 2026-08-02
Ratings & Reviews
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Press & Coverage
Hyfe (via FirstWord HealthTech)
Hyfe Cough Monitoring to be Primary Endpoint in Pivotal Clinical Trial for First Digital Therapeutic to Treat Chronic Cough
Hyfe announced a regulatory agreement with Japan's PMDA for its CoughMonitor Suite to be the primary endpoint in a pivotal clinical trial for a chronic cough digital therapeutic, marking a significant regulatory landmark for objective digital endpoints.
2026-06
Hyfe
New Clinical Trial Evidence Validates Effectiveness of Hyfe's Digital Chronic Cough Platform
Study results demonstrate that Hyfe's digital Behavioral Cough Suppression Therapy reduced cough frequency by over 40% in patients with refractory and unexplained chronic cough.
2025-10
Hyfe
Hyfe to Launch World's First Prescription Digital Therapeutic to Treat Chronic Cough
Hyfe partnered with KYORIN Pharmaceutical Co. Ltd for the development and commercialization of the world's first prescription digital therapeutic (DTx) to treat chronic cough in the Japanese market.
2025-02
Scientific Reports (Springer Nature)
Validation and accuracy of the Hyfe cough monitoring system: a multicenter clinical study
This multicenter observational study validated the Hyfe CoughMonitor wrist-worn device, showing a sensitivity of 90.4% and a low false positive rate in detecting cough events in real-world settings.
2025-01
Ametris
ActiGraph And Hyfe Announce Availability Of New Digital Health Tool For Cough Monitoring
ActiGraph and Hyfe Inc. released a new digital health solution for cough detection using the ActiGraph LEAP wearable, integrating Hyfe's validated cough detection algorithms with ActiGraph's digital measures for physical activity, sleep, and vital signs.
2025-01
Hyfe
New Market Intelligence Report Reveals $15B Opportunity in Chronic Cough Therapeutics, With Zero FDA-Approved Competitors
Hyfe released a market intelligence report highlighting a substantial commercial opportunity in Refractory Chronic Cough (RCC) therapeutics, noting that approximately 100 million patients worldwide lack access to FDA-approved treatments.
2026-01
Hyfe
New Hyfe AI Study Validates the Accuracy of AI-Powered Cough Detection Human Annotators
A study published in BMJ Open Respiratory Research demonstrated that Hyfe's cough detection AI technology is nearly as accurate as human annotators in analyzing cough amount and duration in a real-world environment.
2023-12
Hyfe
Hyfe AI and ActiGraph Partner to Revolutionize Clinical Trials with AI-Powered Cough Detection
Hyfe Inc. partnered with ActiGraph to advance the use of AI-powered cough detection in clinical trials, developing a new digital health tool to collect a comprehensive combination of data.
2023-08
Frequently Asked Questions
Hyfe utilizes AI-powered cough detection and analysis to provide objective, real-world data on cough frequency and characteristics. This data can be used to assess the efficacy of new antitussive drugs, monitor disease progression in respiratory conditions, and identify potential biomarkers for drug response.
Patient compliance with Hyfe largely revolves around consistent use of the recording device (e.g., smartphone, wearable) and ensuring the device is positioned to accurately capture coughs. Clear instructions, user-friendly interfaces, and regular check-ins can help maximize adherence.
While other methods exist, such as manual cough counting by clinicians or sound-activated recorders, Hyfe offers a more automated, continuous, and less intrusive approach. Its AI algorithms are designed to differentiate coughs from other sounds, providing a higher level of accuracy and reducing observer bias.
Pricing for Hyfe's technology in drug discovery research is typically tailored to the scope and duration of the study. It often involves licensing fees for the software, per-patient data analysis costs, and potentially hardware costs if dedicated recording devices are required. Specifics would be discussed with Hyfe directly.
Limitations can include potential for background noise interference, the need for patient cooperation in device usage, and the current focus on cough frequency rather than detailed cough characteristics in some applications. While highly accurate, no system is 100% perfect, and proper study design is crucial to mitigate these.
Hyfe's AI can be trained to identify and categorize different cough characteristics, such as wet vs. dry or productive vs. non-productive, although the primary focus is often on frequency. This differentiation can be highly relevant in drug discovery to assess the specific impact of a therapeutic on different cough phenotypes.
Hyfe adheres to strict data security and privacy protocols, including HIPAA and GDPR compliance, to protect patient data. Data is typically anonymized and encrypted, and access is restricted to authorized personnel, ensuring the confidentiality and integrity of research participants' information.
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| Last Verified: 2026-08-03 | First Added: 2026-08-02
Investors who backed Hyfe
Funded through the company that built this tool.
