Oncoustics AI
Oncoustics AI is a Toronto-based healthtech company applying patented AI to raw ultrasound RF signals for non-invasive, point-of-care diagnostics of liver and other structural diseases, serving hepatologists, endocrinologists, and primary care physicians with a hardware-agnostic SaMD platform.
- Company typePrivate
- Founded2018
- HeadquartersToronto, Canada
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Oncoustics AI does
Oncoustics AI is a Toronto-based health technology company founded in 2018 as a Stanford University spinout that applies patented artificial intelligence and machine learning to raw ultrasound radio-frequency (RF) signals to enable non-invasive, point-of-care tissue characterization and disease diagnostics. The company's core product, the OnX Liver Assessment Solution, is a Software-as-a-Medical-Device (SaMD) that captures and analyzes raw RF signal data (typically discarded in standard imaging) to detect and stage structural liver diseases including fibrosis, steatosis, and inflammation in approximately 5 minutes, without requiring expert sonographers or radiologists. The platform is hardware-agnostic, working on any ultrasound system including low-cost point-of-care devices, and has been validated on over 2,500 patients and trained on more than 600,000 RF images across international clinical partners.
The company generates revenue through multiple streams: a SaaS (Screening-as-a-Service) model offering subscription or per-exam pricing for the OnX platform, OEM/embedded licensing with ultrasound manufacturers such as Interson (SiMPLi Series) and Exact Imaging (ExactVu), and emerging pharmaceutical/CRO partnerships for clinical trial endpoints and treatment monitoring. The go-to-market approach combines direct enterprise field sales to hepatology/GI practices, endocrinology clinics, and primary care networks with channel partnerships through ultrasound OEMs. Customer segments span approximately 16,000 GI/hepatologists in North America as the primary market, with 600,000+ primary care providers as a long-term expansion target, plus pharma/biotech companies for companion diagnostics and clinical trial applications.
Oncoustics has raised approximately $5.5 million CAD (~$4.3 million USD) in seed funding co-led by Creative Ventures and Saltagen Ventures in July 2022, supplemented by grants including the OBIO Early Adopter Health Network Grant and the INOVAIT Focus Fund (up to $2 million CAD). The company has been selected for the Google for Startups Accelerator: Cloud program and is leading a Canadian AI in Healthcare Consortium in partnership with DIGITAL. With a team of 11-50 employees distributed across Toronto, San Francisco Bay Area, Cairo, and Europe/Asia, Oncoustics is advancing FDA 510(k), Health Canada, and CE Mark regulatory submissions for the OnX system, which is currently designated For Investigational Use Only.
Oncoustics AI firmographics
Firmographics- Name
- Oncoustics AI
- Legal name
- Oncoustics
- Website
- https://oncoustics.com
- Company type
- Private
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Oncoustics AI is a Toronto-based healthtech company applying patented AI to raw ultrasound RF signals for non-invasive, point-of-care diagnostics of liver and other structural diseases, serving hepatologists, endocrinologists, and primary care physicians with a hardware-agnostic SaMD platform.
- Ownership category
- akta.pro rank
Oncoustics AI industry classification
Industry- Product category
- AI Medical Imaging Software
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Computer Systems Design and Related Services (54151)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)
- akta.pro secondary industries
- Radiology AI, CAD & Advanced Visualization Software (HLAHABAJ), Medical Imaging AI (HDAAAEAH), Digital & AI-Enabled Diagnostics (algorithmic interpretation, decision support tied to assays) (HLAAALAO), AI Orchestration & Imaging Analytics Platforms (Model Management/Triage) (HLACALAG)
Keywords
Where Oncoustics AI is headquartered
LocationHeadquarters
- HQ city
- Toronto
- HQ country
- Canada
- HQ region
- North America
Offices3 records
Markets served
Oncoustics AI business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- SaaS (Screening as a Service): The company operates on a software-as-a-service model providing screening and diagnostics as a service. The SaaS model saves institutional equipment costs and enhances returns on reimbursements. Revenue is generated through subscriptions or per-exam fees for access to the OnX platform and analysis services.
- OEM/Embedded Licensing: Oncoustics ports its AI solution to ultrasound hardware manufacturers' devices, embedding its technology into their systems. Partnerships with companies like Interson enable deployment through their ultrasound product lines.
- Pharma and CRO Partnerships: Oncoustics is initiating collaborative studies with pharma partners for drug development support and treatment monitoring. The platform serves as a tool for clinical trials and companion diagnostics.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | SaaS subscription model with per-exam or subscription pricing |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels6 records
Oncoustics AI product offering
Product offeringCore offering
Oncoustics AI develops a software-as-a-medical-device (SaMD) platform that applies patented AI and machine learning to raw radiofrequency (RF) ultrasound signals to deliver non-invasive, point-of-care tissue characterization and disease detection. Its flagship product, the OnX Liver Assessment Solution, performs a 5-minute liver exam to assess fibrosis, steatosis, and cirrhosis using any point-of-care ultrasound device without requiring expert sonographers. The platform is hardware-agnostic and being extended to additional organs and inflammation evaluation.
Product overview
Oncoustics AI offers a hardware-agnostic AI platform that transforms low-cost point-of-care ultrasound devices into powerful diagnostic tools. The core product is the OnX Liver Assessment Solution—a software-as-a-medical-device (SaMD) that analyzes raw RF ultrasound signals to detect and stage liver diseases including fibrosis, steatosis, and inflammation. The platform is being expanded with OnX-I for liver inflammation evaluation and has demonstrated applicability across other organs (prostate, kidney, breast, thyroid). The company holds the world's largest RF signal dataset (>4M+ data points) and is pursuing FDA 510(k) clearance for the OnX system.
Differentiator
Problem solved
Functional benefit
Brands
- OnX Liver Assessment Solution: Oncoustics' first product focused on detecting structural liver diseases including fibrosis and steatosis. The SaMD (software as a medical device) solution captures and interrogates raw RF signals from ultrasound to assess structural liver disease, demonstrating 95% AUROC at detecting liver cirrhosis in a 5-minute point of care exam.
Products and services
- OnX Liver Assessment Solution AI-powered software-as-a-medical-device (SaMD) that captures and interrogates raw RF signals from any point-of-care ultrasound device to assess structural liver disease including fibrosis, steatosis, and cirrhosis. Delivers quantitative liver scores in approximately 5 minutes at point of care. For Investigational Use Only; FDA 510(k) submission in progress. Targeted at hepatologists, gastroenterologists, endocrinologists, and primary care physicians.
- OnX-I (OnX-Inflammation) Liver inflammation evaluation tool extending the OnX platform to detect and stage liver inflammation (hepatitis) at point of care without need for blood tests, biopsy, or radiology referral. Addresses a critical biomarker need for disease diagnosis, progression monitoring, and drug development support.
- AI Tissue Characterization Platform Hardware-agnostic AI platform that applies machine learning to raw ultrasound RF signals for tissue characterization across anatomical areas. Currently focused on liver disease with datasets in prostate, kidney, breast, thyroid, and other organs. Mines acoustic biomarkers to enable virtual biopsy capabilities for surveillance, staging, and treatment guidance.
Quantifiable outcome
- 95% AUROC at detecting liver cirrhosis in a 5-minute point of care exam
- +4 more outcomes
Companies that use Oncoustics AI
Customer profileNamed customers7 records
Segments5 records
Ideal customer profiles5 records
Oncoustics AI technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability7 records
Feature6 records
Oncoustics AI partnerships and signals
Strategic signalScale indicators11 records
Recent moves7 records
Expansion highlights6 records
Oncoustics AI competitors and assessment
Company assessmentDirect peers
- Butterfly Network: Butterfly Network produces handheld point-of-care ultrasound (iQ+) integrated with AI-based guidance and interpretation. It overlaps with Oncoustics in the low-cost PoC ultrasound plus embedded AI workflow targeting non-specialist clinicians across multiple indications.
- Echosens: Echosens manufactures FibroScan, the leading non-invasive point-of-care device for liver stiffness and steatosis assessment. Like Oncoustics, Echosens targets hepatology and endocrinology workflows for non-invasive liver disease diagnosis and competes for the same clinical decision-support budget.
- Exact Imaging: Exact Imaging manufactures the ExactVu micro-ultrasound system for prostate and has an active AI partnership with Oncoustics for tissue characterization on its platform. Comparable as an OEM partner competing in the same raw-RF ultrasound AI niche for prostate applications.
- Caption Health: Caption Health (now part of GE HealthCare) developed AI guidance software that enables non-expert clinicians to acquire diagnostic-quality ultrasound images. It shares Oncoustics' thesis that AI on commodity ultrasound hardware can democratize imaging, though its initial focus is cardiac.
Broad incumbents
- Aidoc: Aidoc is a leading clinical AI platform covering CT, MRI, and increasingly ultrasound triage and workflow. It is comparable to Oncoustics as a SaMD imaging-AI company with FDA-cleared algorithms sold into hospital radiology workflows, though its modality and indication mix are broader.
- Siemens Healthineers: Siemens Healthineers (ACUSON ultrasound, AI-Rad Companion) offers a broad AI-enhanced imaging portfolio with ultrasound as a key modality. Comparable as a global OEM with the ability to embed or replace third-party AI like Oncoustics' across its installed base.
- Philips: Philips is a global ultrasound OEM ( EPIQ, Affiniti, Lumify handheld) with an expanding AI ecosystem across its imaging suite. Philips is comparable both as an OEM partner candidate and as a potential competitor embedding liver/structural AI into its ultrasound workflow.
- Viz.ai: Viz.ai is a specialty AI imaging company with multiple FDA-cleared algorithms (notably for stroke triage) and a SaaS commercialization model into health systems. It is comparable as a regulated AI-imaging SaMD company that has scaled enterprise hospital sales.
- GE HealthCare: GE HealthCare sells the world's largest installed base of ultrasound systems (incl. handheld Venue/Vscan) and is embedding AI across its imaging portfolio (Caption Health, Edison). It competes with Oncoustics both as a potential OEM partner and as a vertically integrated AI-ultrasound provider.
Emerging players
- Ultromics: Ultromics applies AI to echocardiography for diagnostic decision support (e.g., HFpEF detection). It is comparable to Oncoustics as a focused AI-ultrasound SaMD startup pursuing FDA clearance, with overlapping engineering talent and clinical validation approach.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
Oncoustics AI social profiles
Digital presenceOncoustics AI financial estimates
Financial estimateRevenue estimate
Valuation estimate
Oncoustics AI leadership team
Management profileNumber of profiles
Profiles23 records
Oncoustics AI funding detail
Funding detailFunding overview
Funding rounds8 records
Investors14 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Oncoustics 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 Oncoustics AI
What does Oncoustics AI do?
Oncoustics AI develops a software-as-a-medical-device (SaMD) platform that applies patented AI and machine learning to raw radiofrequency (RF) ultrasound signals to deliver non-invasive, point-of-care tissue characterization and disease detection. Its flagship product, the OnX Liver Assessment Solution, performs a 5-minute liver exam to assess fibrosis, steatosis, and cirrhosis using any point-of-care ultrasound device without requiring expert sonographers. The platform is hardware-agnostic and being extended to additional organs and inflammation evaluation.
Is Oncoustics AI a public or private company?
Oncoustics AI is a private company. It is classified as venture growth investor backed and is currently operating.
When was Oncoustics AI founded?
Oncoustics AI was founded in 2018. It employs 11 to 50 people.
Where is Oncoustics AI based?
Oncoustics AI is headquartered in Toronto, Canada, in the North America region.
How does Oncoustics AI make money?
Three revenue lines are on record. SaaS (Screening as a Service) is the primary driver. The others are OEM/Embedded Licensing and pharma and CRO Partnerships.
Who are Oncoustics AI's main competitors?
Direct peers on record are Butterfly Network, Echosens, Exact Imaging and Caption Health. Broad incumbents are Aidoc, Siemens Healthineers, Philips, Viz.ai and GE HealthCare. Ultromics is listed as an emerging player.
Does Oncoustics AI have an API?
No public API is recorded for Oncoustics AI.
What industry is Oncoustics AI in?
Oncoustics AI's product category is AI Medical Imaging Software. Its primary akta.pro industry code is HLACANAG, SaMD – Imaging & Signal Analysis (AI/ML), with a secondary code of HLAHABAJ, Radiology AI, CAD & Advanced Visualization Software. Its NAICS code is 334510 and its SIC code is 3841.