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HITLAB

Full company profile

uuid0007q9b

Namestring
HITLAB
Websiteurl
hitlab.org
Company typeenum
Private
Founded yearint
2008
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersNew York, United States
HQ citystring
New York
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
healthcare innovation research, digital health advisory, FDA regulatory consulting, health technology validation, life sciences convening
Industry3 codes
1Health Technology Assessment (HTA) & Reimbursement Policy Bodies
CodeHLAJACAFPrimaryYes
2Data, Surveillance & Digital Public Goods Partnerships for Global Health
CodeHLAJAOANPrimaryNo
3Digital Health, Health Information Systems & Data Programs
CodeBPADAIAJPrimaryNo
NAICS code2 codes
  • Scientific Research and Development Services5417
  • Research and Development in the Physical, Engineering, and Life Sciences54171
SIC code2 codes
  • Services-Commercial Physical & Biological Research8731
  • Services-Health Services8000
Product category
Healthcare Innovation Consulting
Social media profiles2 records
Cost components5 values
Personnel, Operations, Marketing or Sales, Technology or R&D, Others
GTM typeB2B
B2B
Offering typeServices
Services
Core offering1 text field

HITLAB (Healthcare Innovation Technology Lab) is a New York-based healthcare innovation research and advisory organization that convenes cross-sector health leaders through summits such as the People & Planet United Summit and provides regulatory pathway support to digital health and AI-driven medical technology companies. It advises organizations such as Kardi AI on FDA pathway strategy for AI-powered medical devices, while also facilitating dialogue on climate-health intersection and global health equity.

Differentiator
Functional benefit
Problem solved
Product overview1 text field

No product or service information available in the provided sources. The source material references HITLAB's involvement in healthcare innovation summits and a partnership with Kardi AI for FDA pathway cooperation, but does not describe HITLAB's own product portfolio or service offerings.

Product and service2 records
1FDA Regulatory Pathway Support for Digital Health and AI Medical Devices
CategoryRegulatory Affairs Consulting
Description

An advisory and regulatory strategy service for digital health and AI-enabled medical device companies seeking U.S. FDA approval. HITLAB provides regulatory pathway expertise and guidance to support market entry for novel AI-powered diagnostic and monitoring technologies.

2People & Planet United - Global Health & Purpose Summit
CategoryIndustry Convening and Events
Description

A co-hosted health innovation summit convened during New York City Health Innovation Week that brings together 300+ cross-sector leaders to discuss climate-health connections, AI applications in healthcare, and global health equity. Co-hosted with FINN Partners, The Galien Foundation, and 1BusinessWorld.

Scale indicator2 records

Each record includes

Type, Value, Description, Source

Partnership4 partners
1Kardi AI
Strategic tierCoreTypeImplementation/ SI/ Consulting PartnerAnnounced on2026-03-02
Description

Kardi AI is pursuing an FDA pathway in cooperation with HITLAB. HITLAB is providing regulatory pathway support and expertise for Kardi AI's AI-powered long-term ECG monitoring solutions as the company prepares for market entry in the US.

2FINN Partners
Strategic tierCoreTypeStrategic or Co-development Partner
Description

FINN Partners is collaborating with HITLAB, The Galien Foundation, and 1BusinessWorld to host the Second Annual People & Planet United - Global Health & Purpose Summit in New York City as part of New York City Health Innovation Week.

3The Galien Foundation
Strategic tierCoreTypeStrategic or Co-development Partner
Description

The Galien Foundation is co-hosting the Second Annual People & Planet United - Global Health & Purpose Summit with HITLAB, FINN Partners, and 1BusinessWorld. The summit focuses on climate and health connections, AI applications in healthcare, and global health equity.

41BusinessWorld
Strategic tierMinorTypeStrategic or Co-development Partner
Description

1BusinessWorld is co-hosting the People & Planet United Summit alongside HITLAB, FINN Partners, and The Galien Foundation as part of New York City Health Innovation Week.

Recent move4 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight4 records

Each record includes

Type, Description

Peers10 records
1Startup Health
TypeDirect peer
Description

Startup Health operates a global health innovation ecosystem and accelerator supporting health tech founders, directly comparable to HITLAB's role convening innovators and supporting digital health companies.

2Digital Health New York (DHNY)
TypeRegional player
Description

DHNY is a New York-based ecosystem supporting digital health companies and events, mirroring HITLAB's NYC footprint and health innovation convening role.

3NY eHealth Collaborative (NYeC)
TypeRegional player
Description

NYeC is a New York-based health IT collaborative promoting digital health adoption, sharing HITLAB's geography and focus on advancing health technology innovation and policy.

4FasterCures (Milken Institute)
TypeOthers
Description

FasterCures is a Milken Institute center focused on accelerating medical innovation through research, convenings, and policy, comparable to HITLAB's innovation-acceleration mission.

5MATTER
TypeDirect peer
Description

MATTER is a healthcare innovation hub and accelerator that brings together entrepreneurs, clinicians, and industry partners, similar to HITLAB's NYC-based health innovation lab model.

6The Galien Foundation
TypeDirect peer
Description

The Galien Foundation is a co-host of HITLAB's People & Planet United summit and recognizes health innovation through awards, overlapping with HITLAB's mission of advancing and convening healthcare innovation.

7HIMSS
TypeBroad incumbent
Description

HIMSS is a large global health information and technology organization that convenes stakeholders and sets digital health standards, comparable to HITLAB but at a much broader scale and membership-based footprint.

8Rock Health
TypeDirect peer
Description

Rock Health is a digital health venture fund and advisory firm supporting early-stage health technology companies, comparable to HITLAB in providing strategic and regulatory support to digital health startups.

9Cedars-Sinai Accelerator
TypeDirect peer
Description

Cedars-Sinai's accelerator program supports health tech startups with clinical validation and commercialization support, mirroring HITLAB's role in helping health innovators navigate pathway-to-market challenges.

10Health 2.0 Conference
TypeDirect peer
Description

Health 2.0 is a conference and community focused on health technology innovation, closely comparable to HITLAB's NYC Health Innovation Week and summit programming.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat3 records

Each record includes

Type, Details

Key risks4 records

Each record includes

Headline, Details, Source

Key highlights5 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles2 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

HITLAB

Healthcare Innovation Consultinghitlab.org

HITLAB firmographics

Firmographics
Name
HITLAB
Website
https://hitlab.org
Company type
Private
Founded year
2008
Operating status
Operating
Headcount range
11–50 employees
Ownership category
akta.pro rank

HITLAB industry classification

Industry
Product category
Healthcare Innovation Consulting
NAICS
Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)
SIC
Services-Commercial Physical & Biological Research (8731), Services-Health Services (8000)
akta.pro primary industry
Health Technology Assessment (HTA) & Reimbursement Policy Bodies (HLAJACAF)
akta.pro secondary industries
Data, Surveillance & Digital Public Goods Partnerships for Global Health (HLAJAOAN), Digital Health, Health Information Systems & Data Programs (BPADAIAJ)

Keywords

  • Healthcare innovation research
  • Digital health advisory
  • FDA regulatory consulting
  • Health technology validation
  • Life sciences convening

Where HITLAB is headquartered

Location

Headquarters

HQ city
New York
HQ country
United States
HQ region
North America

Markets served

HITLAB business model

Business model
GTM type
B2B
Offering type
Services
Cost components
Personnel, Operations, Marketing or Sales, Technology or R&D, Others

HITLAB product offering

Product offering

Core offering

HITLAB (Healthcare Innovation Technology Lab) is a New York-based healthcare innovation research and advisory organization that convenes cross-sector health leaders through summits such as the People & Planet United Summit and provides regulatory pathway support to digital health and AI-driven medical technology companies. It advises organizations such as Kardi AI on FDA pathway strategy for AI-powered medical devices, while also facilitating dialogue on climate-health intersection and global health equity.

Product overview

No product or service information available in the provided sources. The source material references HITLAB's involvement in healthcare innovation summits and a partnership with Kardi AI for FDA pathway cooperation, but does not describe HITLAB's own product portfolio or service offerings.

Differentiator

Problem solved

Functional benefit

Products and services

  • FDA Regulatory Pathway Support for Digital Health and AI Medical Devices An advisory and regulatory strategy service for digital health and AI-enabled medical device companies seeking U.S. FDA approval. HITLAB provides regulatory pathway expertise and guidance to support market entry for novel AI-powered diagnostic and monitoring technologies.
  • People & Planet United - Global Health & Purpose Summit A co-hosted health innovation summit convened during New York City Health Innovation Week that brings together 300+ cross-sector leaders to discuss climate-health connections, AI applications in healthcare, and global health equity. Co-hosted with FINN Partners, The Galien Foundation, and 1BusinessWorld.

Companies that use HITLAB

Customer profile

Ideal customer profiles2 records

HITLAB technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

HITLAB partnerships and signals

Strategic signal

Partnerships

Four partnerships are on record, tiered core and minor.

  • Kardi AIcoreImplementation/ SI/ Consulting Partner · 2 March 2026Kardi AI is pursuing an FDA pathway in cooperation with HITLAB. HITLAB is providing regulatory pathway support and expertise for Kardi AI's AI-powered long-term ECG monitoring solutions as the company prepares for market entry in the US.
  • FINN PartnerscoreStrategic or Co-development PartnerFINN Partners is collaborating with HITLAB, The Galien Foundation, and 1BusinessWorld to host the Second Annual People & Planet United - Global Health & Purpose Summit in New York City as part of New York City Health Innovation Week.
  • The Galien FoundationcoreStrategic or Co-development PartnerThe Galien Foundation is co-hosting the Second Annual People & Planet United - Global Health & Purpose Summit with HITLAB, FINN Partners, and 1BusinessWorld. The summit focuses on climate and health connections, AI applications in healthcare, and global health equity.
  • 1BusinessWorldminorStrategic or Co-development Partner1BusinessWorld is co-hosting the People & Planet United Summit alongside HITLAB, FINN Partners, and The Galien Foundation as part of New York City Health Innovation Week.

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

HITLAB competitors and assessment

Company assessment

Direct peers

  • Startup Health: Startup Health operates a global health innovation ecosystem and accelerator supporting health tech founders, directly comparable to HITLAB's role convening innovators and supporting digital health companies.
  • MATTER: MATTER is a healthcare innovation hub and accelerator that brings together entrepreneurs, clinicians, and industry partners, similar to HITLAB's NYC-based health innovation lab model.
  • The Galien Foundation: The Galien Foundation is a co-host of HITLAB's People & Planet United summit and recognizes health innovation through awards, overlapping with HITLAB's mission of advancing and convening healthcare innovation.
  • Rock Health: Rock Health is a digital health venture fund and advisory firm supporting early-stage health technology companies, comparable to HITLAB in providing strategic and regulatory support to digital health startups.
  • Cedars-Sinai Accelerator: Cedars-Sinai's accelerator program supports health tech startups with clinical validation and commercialization support, mirroring HITLAB's role in helping health innovators navigate pathway-to-market challenges.
  • Health 2.0 Conference: Health 2.0 is a conference and community focused on health technology innovation, closely comparable to HITLAB's NYC Health Innovation Week and summit programming.

Regional players

  • Digital Health New York (DHNY): DHNY is a New York-based ecosystem supporting digital health companies and events, mirroring HITLAB's NYC footprint and health innovation convening role.
  • NY eHealth Collaborative (NYeC): NYeC is a New York-based health IT collaborative promoting digital health adoption, sharing HITLAB's geography and focus on advancing health technology innovation and policy.

Others

  • FasterCures (Milken Institute): FasterCures is a Milken Institute center focused on accelerating medical innovation through research, convenings, and policy, comparable to HITLAB's innovation-acceleration mission.

Broad incumbents

  • HIMSS: HIMSS is a large global health information and technology organization that convenes stakeholders and sets digital health standards, comparable to HITLAB but at a much broader scale and membership-based footprint.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks4 records

Key highlights5 records

Customer concentration

HITLAB social profiles

Digital presence

HITLAB financial estimates

Financial estimate

Revenue estimate

Valuation estimate

HITLAB leadership team

Management profile

Number of profiles

Profiles2 records

HITLAB funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

HITLAB M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about HITLAB

What does HITLAB do?

HITLAB (Healthcare Innovation Technology Lab) is a New York-based healthcare innovation research and advisory organization that convenes cross-sector health leaders through summits such as the People & Planet United Summit and provides regulatory pathway support to digital health and AI-driven medical technology companies. It advises organizations such as Kardi AI on FDA pathway strategy for AI-powered medical devices, while also facilitating dialogue on climate-health intersection and global health equity.

When was HITLAB founded?

HITLAB was founded in 2008. It employs 11 to 50 people.

Where is HITLAB based?

HITLAB is headquartered in New York, United States, in the North America region.

Who are HITLAB's main competitors?

Direct peers on record are Startup Health, MATTER, The Galien Foundation, Rock Health, Cedars-Sinai Accelerator and Health 2.0 Conference. Regional players are Digital Health New York (DHNY) and NY eHealth Collaborative (NYeC). FasterCures (Milken Institute) is listed as an others. HIMSS is listed as a broad incumbent.

Does HITLAB have an API?

No public API is recorded for HITLAB.

What industry is HITLAB in?

HITLAB's product category is Healthcare Innovation Consulting. Its primary akta.pro industry code is HLAJACAF, Health Technology Assessment (HTA) & Reimbursement Policy Bodies, with a secondary code of HLAJAOAN, Data, Surveillance & Digital Public Goods Partnerships for Global Health. Its NAICS code is 5417 and its SIC code is 8731.

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Live signals
NJBIZSpotitEarly partners with HITLAB to advance dog-sniffing cancer testSpotitEarly, an Englewood-based biotech startup, announced a strategic partnership on July 16 with HITLAB, a New York City-headquartered health technology research organization, to accelerate U.S. commercialization of its breath-based cancer detection test that uses trained dogs and AI to identify cancer odor signatures in volatile organic compounds. The test demonstrated approximately 94% accuracy in a two-year clinical trial involving 1,386 individuals, and SpotitEarly is preparing to launch its breast cancer breath test next year while conducting additional clinical studies with leading U.S. health systems. The company, which has raised more than $20.3 million in funding as of May 2025, is also launching a national investor roadshow this month ahead of its next funding round.FinancialContent Business PageCatching Cancer Earlier, One Breath at a Time: SpotitEarly Partners with HITLAB to Accelerate Its U.S. LaunchSpotitEarly, a multi-cancer early-detection company, announced a strategic partnership with HITLAB to accelerate its U.S. commercialization and capital development for its breath-based cancer screening test. The LUCID Bio-AI Hybrid system, which achieved 93.9% sensitivity and 94.3% specificity in the peer-reviewed Rainbow Study, combines machine learning with trained canine olfaction to detect cancer through breath odor signatures. HITLAB will support SpotitEarly's U.S. growth through investor introductions, strategic advisory, and speaking opportunities as the company prepares for a 2027 market launch and conducts ongoing clinical studies with leading U.S. health systems.Business Wire BlogCatching Cancer Earlier, One Breath at a Time: SpotitEarly Partners with HITLAB to Accelerate Its U.S. LaunchSpotitEarly announced a strategic partnership with HITLAB to accelerate U.S. commercialization of its Bio-AI Hybrid breath test for early cancer detection, leveraging HITLAB\'s healthcare investor network and health-system relationships. The LUCID platform, which combines machine learning with trained canine olfaction to detect cancer odor signatures in breath, achieved 93.9% sensitivity and 94.3% specificity in the peer-reviewed Rainbow Study published in Scientific Reports, with plans to bring its breast cancer test to market in 2027 pending regulatory approval. The company is conducting multiple clinical studies with U.S. health systems including Hackensack Meridian Health and the University of Pennsylvania, and is launching a national investment roadshow from June 16-30 in New York, Miami, Los Angeles, and Palo Alto.Techbuzznews“No One Sane Goes Into Healthcare for the Money”: A Hackathon Panel on Mission and GritAt a HITLAB and UVU hackathon, healthcare entrepreneurs Richard Hanbury and Andrew Holman discussed why they entered the field, emphasizing mission over money. Hanbury said multimodal care and AI are the future, while Holman highlighted stress physiology and regulatory predictability. The panel's insights may inform future Utah healthcare policy.TechbuzznewsAt UVU's HITLAB Innovation World Cup, a Maternal Health Startup Took Top HonorsDave Esra's maternal health app BobiHealth won the HITLAB Innovation World Cup pitch competition at Utah Valley University, drawing 1,277 applicants and a $96K prize pool. The app, launched in January 2026, has 30,000 downloads and aims to reduce maternal mortality through continuous monitoring. Esra is seeking clinical pilots to validate outcomes for Medicaid contracts.Business Wire BlogHITLAB Validates MedsEngine’s Value in Treating Chronic DiseasesHITLAB released a Summary of Evidence Paper evaluating MedsEngine, an EHR-integrated clinical decision support platform. The evaluation found MedsEngine supports four disease modules covering over 60% of the adult population and nearly 64% of chronic disease cost, with users achieving US-leading hypertension control for over 90% of patients in less than two office visits.TechbuzznewsUVU to Host Global Competition for Healthcare, AI and Digital IdentityUtah Valley University and HITLAB will host two competitions on AI, healthcare, and digital identity, including a hackathon and the Healthcare Innovation World Cup. Applications open May 12 and close June 3, with finalists announced June 10 and finals on June 17-18. The hackathon features cash bounties from three companies.PR NewswirePeople & Planet United Summit Brings Together Cross-Sector Voices to Advance Health, AI Innovation, and Global ResponsibilityFINN Partners, in collaboration with HITLAB, The Galien Foundation, and 1BusinessWorld, is hosting the Second Annual People & Planet United - Global Health & Purpose Summit in New York City as part of New York City Health Innovation Week. The summit will convene 30+ health and sustainability leaders from life sciences, technology, education, travel, and policy sectors to discuss climate and health connections, AI applications in healthcare, global health equity, rural health, health data security, and women's health. Building on the 2025 event that drew over 300 leaders, this year's program aims to move from dialogue to action, connecting environmental conditions to patient outcomes across different settings.HitlabHITLAB Partners with Quai.MD to Advance AI-Powered Clinical Workflows in Emergency CareHITLAB has entered a strategic partnership with Quai.MD to conduct an independent heuristic evaluation of the latter's AI-powered clinical navigation platform for emergency care. The collaboration aims to assess usability and workflow integration within electronic health records to reduce diagnostic errors and administrative burdens on physicians.PR NewswireVirtual Summit Unites Global Health and Sustainability Leaders to Launch NYC Health Innovation WeekFINN Partners, in collaboration with HITLAB, the Galien Foundation, and 1BusinessWorld, will present the Global Health & Purpose Summit 2025 on May 5, 2025, as a virtual pre-conference event launching New York City Health Innovation Week. The summit, themed "People and Planet United," will gather business, NGO, and policy leaders alongside health and environmental innovators to discuss cross-sector collaboration at the intersection of human health and planetary sustainability. Following the virtual programming, organizers will co-host a networking reception in New York City to facilitate connections among attendees.