What Innolitics does

Innolitics is an Austin, Texas-based engineering, regulatory, and management consulting firm founded in 2012 that focuses exclusively on AI-enabled medical device software (Software as a Medical Device). The firm helps medical device CEOs and founders convert clinical AI concepts into FDA-cleared, market-ready products by offering a vertically integrated delivery model that combines software engineering, FDA regulatory strategy, and cybersecurity compliance under a single engagement. Headquartered at 1101 West 34th St. #550, Innolitics operates as Innolitics LLC with no disclosed external institutional or venture funding and a headcount of 11–50 employees.

The service portfolio is organized around four core capabilities: end-to-end SaMD software development, FDA regulatory consulting (including 510(k), De Novo, Q-Sub, and Breakthrough Device Designation pathways), FDA cybersecurity documentation and hold-letter response, and Quality Management System implementation. Building on these services, Innolitics has productized a 'solutions' tier with fixed-scope, guaranteed-outcome offerings — 9-month AI/ML FDA clearance, 2-week BDD application, 4-week presub plus BDD, 2-month QMS delivery, and 3-month FDA hold-letter resolution. The firm also operates free public tools (an FDA Devices Database at fda.innolitics.com and a web-based DICOM Browser) and maintains an open-source Regulatory Documentation Manager (RDM) on GitHub, all of which function as lead-generation channels into the core services business.

Innolitics generates revenue through fixed-price or milestone-based professional services engagements; no public pricing is disclosed. Its customer base spans AI/ML medical imaging startups (Rology, Envisionit Deep AI, SimBioSys, Body Check, RadUnity, SmileDx/Cube Click, Neosoma, Prognosia Breast), enterprises (Varian Medical Systems, NVIDIA, Butterfly Network, Prenuvo, Indica Labs, Magnetic Insight, Transonic, AI Metrics, OXOS, Echo IQ, Enlitic, PhotoniCare), and academic institutions (Washington University School of Medicine, University of Alabama, Mary Bird Perkins Cancer Center), with reported cumulative outcomes of 60+ FDA-cleared products and 80+ devices shipped. The go-to-market motion is sales-led and relationship-based, targeting founders and regulatory teams at medical device companies through content marketing, a newsletter, and direct outreach.

Name

Innolitics

Legal name

Innolitics LLC

Website

https://innolitics.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Innolitics is an Austin-based engineering and regulatory consulting firm that helps AI/ML medical device startups and enterprises achieve FDA clearance for SaMD products. Founded in 2012, the firm offers guaranteed-outcome services spanning software development, regulatory strategy, and cybersecurity compliance.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory & Software Consulting

NAICS

Computer Systems Design and Related Services (54151), Other Scientific and Technical Consulting Services (541690)

SIC

Services-Computer Programming Services (7371)

akta.pro primary industry

DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)

akta.pro secondary industries

Software as a Medical Device (SaMD) – Clinical Decision & Diagnostic Software (HLACANAD), SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)

Keywords

• FDA regulatory consulting
• Medical device software
• AI/ML SaMD development
• FDA 510(k) clearance
• Medical device cybersecurity

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. FDA Regulatory Consulting: Professional consulting services for FDA regulatory strategy, 510(k) submissions, De Novo requests, Breakthrough Device Designation applications, and FDA hold letter responses. Revenue generated through project-based engagements with guaranteed outcomes.
2. Software Development Services: End-to-end SaMD development including AI/ML algorithm development, software engineering, and FDA documentation. Revenue through fixed-price project engagements with timeline guarantees.
3. FDA Cybersecurity Services: Cybersecurity documentation and consulting for FDA submissions, including threat modeling, SBOM creation, and response to FDA cybersecurity hold letters.
4. Quality Management System (QMS) Services: QMS implementation and support services with guaranteed 2-month delivery timeline.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Innolitics is an engineering, regulatory, and management consulting firm that delivers end-to-end services for AI-enabled medical device software (SaMD). Its offerings span full-stack medical device software development, FDA regulatory strategy and submissions (510(k), De Novo, BDD, Q-Sub), FDA cybersecurity documentation and hold-letter response, and quality management system (QMS) implementation. Engagements are delivered with guaranteed timelines and outcomes, consolidating clinical, engineering, and regulatory expertise under one roof.

Product overview

Innolitics is an engineering, regulatory, and management consulting firm focused exclusively on AI-enabled medical device software. The company provides a portfolio of consulting services and solutions organized around FDA regulatory affairs for medical devices, particularly AI/ML SaMD (Software as a Medical Device). Core services include Software Development (end-to-end SaMD), FDA Regulatory Consulting, and FDA Cybersecurity. Solutions include Guaranteed AI/ML FDA Clearance (9-month timeline), FDA Hold Letter Response, Regulatory Strategy with Q-Sub and BDD in 4 Weeks, Guaranteed Breakthrough Device Designation in 2 Weeks, Guaranteed QMS in 2 Months, and Medical Imaging AI Development. Additionally, Innolitics offers free public tools including the FDA Devices Database (for searching FDA 510(k) clearances) and DICOM Browser (web-based DICOM viewer). The company also maintains an open-source Regulatory Documentation Manager (RDM) for medical device design controls.

Differentiator

Problem solved

Functional benefit

Products and services

• Software Development (End-to-End SaMD) Full-stack medical device software development service for new or existing products, including AI/ML algorithm development, web development, and FDA compliance, for medical device companies building SaMD.
• FDA Regulatory Consulting Regulatory strategy and consulting service to determine the best path to US market or address custom regulatory needs for medical device companies.
• FDA Cybersecurity Cybersecurity document preparation service for FDA submissions and response to Hold Letters, covering threat modeling, SBOMs, and vulnerability monitoring for medical device companies.
• Guaranteed AI/ML FDA Clearance Outcome-guaranteed solution for AI/ML SaMD FDA submission and clearance in 9 months, covering 510(k) and De Novo pathways, for medical device companies seeking first-time or repeat AI/ML clearance.
• FDA Hold Letter Response Resolution service for FDA-identified major cybersecurity, software, or AI/ML deficiencies to clear hold letters and achieve FDA clearance, for medical device companies facing submission setbacks.
• Regulatory Strategy, Q-Sub, and BDD in 4 Weeks Guaranteed presubmission (Q-Sub) and Breakthrough Device Designation (BDD) application delivered in 4 weeks, with optional 2-week rush delivery, for AI/ML medical device companies seeking expedited regulatory positioning.
• Guaranteed Breakthrough Device Designation Guaranteed Breakthrough Device Designation (BDD) application in 2 weeks to unlock funding, accelerate FDA review, and signal market leadership, for medical device companies pursuing breakthrough status.
• Guaranteed QMS in 2 Months Quality Management System (QMS) implementation and support service with guaranteed 2-month delivery, for medical device companies needing compliant QMS infrastructure.
• Medical Imaging AI Development Product development partnership for AI-enabled medical imaging applications including CT, MRI, radiology, and pathology imaging, for medical imaging AI companies.
• FDA Devices Database Publicly accessible database of FDA-cleared medical devices, searchable by 510(k) number and other criteria, provided free to the public.
• DICOM Browser Web-based DICOM image viewer and browser tool for medical imaging analysis, provided free to the public.
• Regulatory Documentation Manager (RDM) Open-source regulatory documentation manager built by Innolitics for medical device design controls and FDA compliance documentation.

Quantifiable outcome

• Typical timeline from 2 years compressed to 6 months for FDA clearance
• +5 more outcomes

Named customers12 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature4 records

Scale indicators5 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Veeva Systems: Veeva provides life sciences regulatory, quality, and clinical SaaS solutions across pharma and medical devices, serving as a broader technology incumbent that intersects with Innolitics' regulatory content and QMS adjacencies.
• MasterControl: MasterControl provides enterprise QMS, regulatory, and quality management software across life sciences, serving as a broader incumbent that overlaps with Innolitics' QMS services but across multiple regulated verticals.

Direct peers

• NAMSA: NAMSA is a medical device-focused CRO offering regulatory strategy, testing, and clinical evaluation services — a long-standing peer for full-cycle medical device regulatory engagements similar to Innolitics' offerings.
• Greenlight Guru (by MasterControl): Greenlight Guru offers QMS and design control software purpose-built for medical device companies, directly overlapping with Innolitics' QMS implementation and documentation services.
• CompliancePath: CompliancePath provides regulatory and quality consulting for medical device companies including 510(k) submissions, QMS, and remediation work, competing directly with Innolitics for AI/SaMD regulatory clients.
• RQM+: RQM+ is a medical device regulatory and quality consulting firm providing 510(k), CE marking, QMS, and clinical strategy services — the closest direct competitor to Innolitics' end-to-end SaMD regulatory practice.

Regional players

• Propel (by Lighthouse): ResMed-owned Propel provides regulatory, quality, and clinical consulting for medical device companies, comparable as a regional-adjacent consulting peer with overlap in FDA submission support.

Emerging players

• Pro-ficiency: Pro-ficiency uses simulation-based training and protocol compliance tools for clinical trials, adjacent to Innolitics' compliance and process focus for medical device software development.
• Galen Data: Galen Data provides validated cloud-based software and compliance services for medical device SaaS companies, comparable to Innolitics as an emerging player in SaMD regulatory/compliance enablement.
• RegDesk (by Ardent>): RegDesk is a regulatory intelligence and compliance platform for medical device and IVD companies, an emerging technology peer to Innolitics' content-driven regulatory tools.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• GitHubgithub.com/innolitics
• LinkedInlinkedin.com/company/innolitics

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Innolitics