Huma.AI
Huma.AI (doing business as Qoniq) is an AI-powered healthcare data platform that uses NLP and machine learning to automate literature review and post-market surveillance for medical device, IVD, and pharmaceutical Medical Affairs teams under EU MDR/IVDR regulations.
- Company typePrivate
- Founded2021
- HeadquartersCary, United States
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What Huma.AI does
Huma.AI, doing business as Qoniq, is a private Delaware-incorporated healthcare AI company founded in 2018 and headquartered in Cary, North Carolina, with executive operations in Palo Alto, California. The company builds an AI-powered healthcare data platform that applies machine learning and natural language processing to scientific literature, regulatory documents, and post-market surveillance datasets. Its core products include an AI-assisted literature search platform validated through a peer-reviewed partnership with QIAGEN across multiple IVD assays, and a Post-Market Surveillance (PMS) module purpose-built for medical device and IVD manufacturers navigating EU MDR/IVDR compliance. The platform demonstrates a 10x improvement in relevant article identification and reduces literature review turnaround times from weeks to minutes or hours.
Huma.AI serves enterprise customers in the medical device, in vitro diagnostics, and pharmaceutical Medical Affairs verticals. Its customer base is concentrated, with QIAGEN disclosed as a named strategic technology partner and the only identified enterprise reference customer. The company's go-to-market is enterprise field sales targeting regulatory-grade buyers, with distribution augmented through strategic OEM-style partnerships such as QIAGEN. Marketing channels emphasize industry events, peer-reviewed publications, and challenge/grant programs (notably the Women Who Tech FemTech and HealthTech Challenge in 2021).
The business model is subscription or licensing-based recurring revenue for the PMS platform, though pricing is not publicly disclosed. Capital structure is venture-backed, with approximately $14.95 million raised cumulatively across a 2019 Fusion Fund seed, a 2021 Women Who Tech grant, a February 2022 $9.5 million Series A led by Excelerate Health Ventures, a July 2024 $2.5 million exempt insider offering (~$2.0M sold), and an April 2025 ~$1.0 million bridge round. The company operates with 1-10 employees and has not disclosed revenue or ARR.
Huma.AI firmographics
Firmographics- Name
- Huma.AI
- Legal name
- Huma.AI, Inc.
- Website
- https://huma.ai
- Company type
- Private
- Founded year
- 2021
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Huma.AI (doing business as Qoniq) is an AI-powered healthcare data platform that uses NLP and machine learning to automate literature review and post-market surveillance for medical device, IVD, and pharmaceutical Medical Affairs teams under EU MDR/IVDR regulations.
- Ownership category
- akta.pro rank
Huma.AI industry classification
Industry- Product category
- Healthcare Regulatory Compliance and Medical Affairs Analytics Software
- NAICS
- Software Publishers (5132), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)
- akta.pro primary industry
- Data Aggregation, Interoperability & APIs for RPM (FHIR/IoMT Gateways) (HLACAFAO)
- akta.pro secondary industry
- AI/Analytics for RPM (Risk Stratification, Alerts, Predictive) (HLACAFAM)
Keywords
Where Huma.AI is headquartered
LocationHeadquarters
- HQ city
- Cary
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Huma.AI business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure
Revenue model
- PMS Platform Licensing/Subscription: AI-powered platform providing post-market surveillance solutions to medical device and IVD manufacturers on a subscription or licensing model, with the company scaling resources and technology through Series A funding
Go-to-market motion1 record
Distribution channels2 records
Marketing channels3 records
Huma.AI product offering
Product offeringCore offering
Huma.AI (commercialized as Qoniq) sells an AI-powered healthcare data analytics platform that uses machine learning and natural language processing to automate post-market surveillance, scientific literature review, and evidence synthesis for medical device, IVD, and pharmaceutical manufacturers. The platform delivers regulatory-grade outputs for EU MDR/IVDR compliance and supports Medical Affairs workflows with expert-guided analysis and standardized deliverables such as PRISMA reviews and Standard Response Letters.
Product overview
Huma.AI offers an AI-powered healthcare data platform focused on post-market surveillance for medical device and IVD manufacturers. The platform includes a PMS solution leveraging ML and NLP to enable faster, more accurate data collection and compliance management, reducing literature review times from weeks to minutes. The company also partnered with QIAGEN to develop an AI-assisted literature search platform for IVD assays under EU MDR/IVDR regulations.
Differentiator
Problem solved
Functional benefit
Products and services
- Qoniq AI-Powered Healthcare Data Platform An enterprise AI analytics platform that aggregates, analyzes, and monitors healthcare evidence and post-market data for life sciences organizations. The platform combines ML and NLP with embedded expert guidance to deliver scientifically defensible outputs and is sold on a subscription basis to medical device, IVD, and pharmaceutical manufacturers.
- Post-Market Surveillance (PMS) Solution A regulatory-grade solution for medical device and IVD manufacturers that automates post-market surveillance activities, including literature review, data collection, and analysis, to satisfy EU MDR and IVDR requirements. The solution reduces literature review cycles from weeks to minutes while improving precision.
- AI-Assisted Literature Search Platform An AI-driven literature search and review platform developed with QIAGEN that automates identification of relevant scientific publications for post-market surveillance of IVD assays. Demonstrated ten-fold increases in relevant article identification and significantly higher precision than manual searches, validated across RGQ MDx, digene HC2 HPV DNA Test, QIAstat SARS-CoV-2 Panel, NeuMoDx SARS-CoV-2, HBV, CMV, and HIV-1 assays.
- Expert-Guided Analysis Service A professional services offering that pairs the Qoniq AI platform with experienced Medical and Scientific Affairs experts to design, implement, and evolve tailored analytical workflows for clients. The service supports generation of standardized scientific deliverables including PRISMA reviews and Standard Response Letters with traceable evidence.
Quantifiable outcome
- Ten-fold increase in relevant article identification compared to manual searches
- +3 more outcomes
Companies that use Huma.AI
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles3 records
Huma.AI technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature3 records
Huma.AI partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- QIAGENcorePartnership between QIAGEN and Huma.AI for developing an AI-assisted literature search platform for post-market surveillance of in vitro diagnostic assays under EU MDR/IVDR regulations. The platform demonstrated ten-fold increases in relevant article identification and significantly higher precision rates compared to manual searches, covering multiple diagnostic assays including RGQ MDx, digene HC2 HPV DNA Test, QIAstat SARS-CoV-2 Panel, NeuMoDx SARS-CoV-2, HBV, CMV, and HIV-1 assays.
Scale indicators4 records
Recent moves6 records
Expansion highlights5 records
Huma.AI competitors and assessment
Company assessmentEmerging players
- Within3: Life sciences insights management platform for Medical Affairs, KOL engagement, and scientific exchange. Comparable to Qoniq's broader Medical Affairs positioning around KOL relationship management and scientific dialogue.
- Egnyte: Content collaboration and governance platform with life sciences vertical capabilities for regulated content (GxP, validation). Adjacent competitor in the regulated evidence/document management space Huma.AI serves.
- Linguamatics (an IQVIA company): NLP platform for healthcare and life sciences text mining, including literature mining, clinical trial analytics, and regulatory intelligence. Now part of IQVIA but historically a direct NLP competitor to Huma.AI's literature analysis capabilities.
- CubeWerx (life sciences AI): Not a confident direct match; flagged as OTHERS placeholder if needed.
Direct peers
- Sorcero: AI platform purpose-built for life sciences Medical Affairs, providing literature intelligence, insights management, and scientific content generation. Directly comparable to Huma.AI/Qoniq in targeting Medical Affairs teams at pharma and biotech with NLP-driven evidence synthesis.
- ArisGlobal: Life sciences technology platform offering regulatory affairs, pharmacovigilance, and document management solutions with AI capabilities. Closely overlaps with Huma.AI's post-market surveillance and EU MDR/IVDR compliance offerings.
- Mendel: AI platform for healthcare and life sciences that structures unstructured clinical and scientific data. Comparable to Huma.AI in applying NLP/ML to medical literature and clinical evidence for enterprise life sciences customers.
Broad incumbents
- Veeva Systems: Dominant cloud SaaS provider for life sciences (Veeva Vault, Veeva MedComms). Competes with Huma.AI/Qoniq across medical affairs, regulatory content management, and scientific exchange workflows for pharma and medtech.
- Certara: Biosimulation and regulatory science technology provider serving pharma and medical device companies. Overlaps with Huma.AI in regulatory submission support, evidence synthesis, and life sciences compliance tooling.
- IQVIA: Global clinical and commercial life sciences services giant with AI/NLP capabilities (including Linguamatics) for literature review, regulatory affairs, and real-world evidence. Competes with Huma.AI in regulatory-grade analytics as part of a much broader services portfolio.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Huma.AI social profiles
Digital presenceHuma.AI financial estimates
Financial estimateRevenue estimate
Valuation estimate
Huma.AI leadership team
Management profileNumber of profiles
Huma.AI funding detail
Funding detailFunding overview
Funding rounds6 records
Investors11 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Huma.AI M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Huma.AI
What does Huma.AI do?
Huma.AI (commercialized as Qoniq) sells an AI-powered healthcare data analytics platform that uses machine learning and natural language processing to automate post-market surveillance, scientific literature review, and evidence synthesis for medical device, IVD, and pharmaceutical manufacturers. The platform delivers regulatory-grade outputs for EU MDR/IVDR compliance and supports Medical Affairs workflows with expert-guided analysis and standardized deliverables such as PRISMA reviews and Standard Response Letters.
Is Huma.AI a public or private company?
Huma.AI is a private company. It is classified as venture growth investor backed and is currently operating.
When was Huma.AI founded?
Huma.AI was founded in 2021. It employs 1 to 10 people.
Where is Huma.AI based?
Huma.AI is headquartered in Cary, United States, in the North America region.
How does Huma.AI make money?
One revenue line is on record: PMS Platform Licensing/Subscription.
Who are Huma.AI's main competitors?
Emerging players on record are Within3, Egnyte, Linguamatics (an IQVIA company) and CubeWerx (life sciences AI). Direct peers are Sorcero, ArisGlobal and Mendel. Broad incumbents are Veeva Systems, Certara and IQVIA.
Does Huma.AI have an API?
No public API is recorded for Huma.AI.
What industry is Huma.AI in?
Huma.AI's product category is Healthcare Regulatory Compliance and Medical Affairs Analytics Software. Its primary akta.pro industry code is HLACAFAO, Data Aggregation, Interoperability & APIs for RPM (FHIR/IoMT Gateways), with a secondary code of HLACAFAM, AI/Analytics for RPM (Risk Stratification, Alerts, Predictive). Its NAICS code is 5132.