16 Bit

What 16 Bit does

16 Bit is a Toronto-based AI medical imaging company that develops Software as a Medical Device (SaMD) for radiology workflows. The company was founded in 2016 by Canadian-trained radiologists Alexander Bilbily and Mark Cicero following their first-place finish in the 2017 RSNA machine learning challenge for pediatric bone age assessment.

The company's two core products are built on deep convolutional neural networks trained on proprietary datasets. Rho is an opportunistic screening system that analyzes routinely captured x-rays (chest, thoracic spine, lumbar spine, pelvis, knee, hand/wrist) to identify patients at risk of low bone mineral density, assigning a Rho Score of 1-10 within four minutes and integrating directly into hospital PACS workflows. Physis is an AI-driven smart atlas for pediatric bone age estimation using a licensed digital Greulich & Pyle reference, validated at 4.3 months mean absolute error. Rho is protected by granted US, Canadian, and Israeli patents and has validated at AUC of 0.82-0.89 across three independent clinical datasets.

16 Bit generates revenue primarily through subscription-based software licensing priced by gross annual x-ray volume for Rho, with Physis available via a 7-day free trial followed by subscription. Go-to-market combines direct enterprise sales to hospitals and imaging centers, channel partnerships through GE Healthcare's Edison platform, and self-serve product-led growth for Physis. Both products are Health Canada Class II cleared; Rho additionally holds FDA Breakthrough Device designation and FDA De Novo Marketing Authorization (April 2024). To date, the company has primarily been funded through non-dilutive grants (Amgen Canada, Digital Technology Supercluster, INOVAIT Focus Fund) totaling approximately CAD 4.85M, and operates with 11-50 employees serving primarily Canadian enterprise healthcare customers.

Name

16 Bit

Legal name

16BIT INC

Website

https://16bit.ai

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

16 Bit builds FDA- and Health Canada-cleared AI software for radiology: Rho opportunistically screens routine x-rays for low bone mineral density, and Physis automates pediatric bone age assessment. The company serves hospitals, imaging centers, and radiologists.

Ownership category

akta.pro rank

Product category

Medical Imaging AI Software

NAICS

Scientific Research and Development Services (5417)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)

akta.pro secondary industries

Software as a Medical Device (SaMD) – Clinical Decision & Diagnostic Software (HLACANAD), Medical Imaging AI (HDAAAEAH), AI Orchestration & Imaging Analytics Platforms (Model Management/Triage) (HLACALAG)

Keywords

• Medical imaging AI
• Bone density screening
• Pediatric radiology software
• Opportunistic screening
• Radiology workflow software

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Rho - Software License Subscription: Subscription-based pricing model for Rho software medical device. Pricing based on gross annual x-ray volume of the healthcare institution. Payments can be made monthly or annually with invoicing at the beginning of each payment period. Licensed by Health Canada and FDA De Novo authorized.
2. Physis - Software License Subscription: Subscription-based licensing for Physis bone age assessment software. Offers 7-day free trial for initial customer acquisition. Health Canada Class II medical device clearance.

Pricing tiers

Go-to-market motion4 records

Distribution channels4 records

Marketing channels5 records

Core offering

16 Bit develops AI-driven Software as a Medical Device (SaMD) products for radiology. Its flagship product Rho analyzes routinely captured x-rays to opportunistically screen patients for low bone mineral density (osteoporosis), while Physis is an AI-driven smart atlas that automates pediatric bone age assessment using the Greulich & Pyle methodology. Both products integrate directly into hospital PACS workflows.

Product overview

16 Bit offers two FDA and Health Canada-cleared AI-powered Software as a Medical Device (SaMD) products: Rho™ and Physis™. Rho is an opportunistic screening system that analyzes standard X-rays to detect low bone mineral density, while Physis is a smart atlas for pediatric bone age assessment. Both products leverage computer vision and predictive analytics to improve healthcare outcomes through AI-driven analysis of medical imaging.

Differentiator

Problem solved

Functional benefit

Brands

• Rho: AI-driven opportunistic screening system for low bone mineral density. Utilizes routinely captured x-rays to identify patients at risk of osteoporosis. FDA De Novo authorized and Health Canada licensed.
• Physis

Products and services

• Rho AI-driven opportunistic screening software that analyzes routinely captured x-rays (frontal projections of chest, thoracic spine, lumbar spine, pelvis, knee, and hand/wrist) to identify patients at risk of low bone mineral density (osteoporosis). Rho automatically scans eligible x-rays and alerts radiologists of patients with possible low BMD via a Rho Score (1-10), with results sent to the PACS workstation. Licensed by Health Canada and FDA De Novo authorized, and protected by U.S. Patent No. US11737704B2.
• Physis AI-driven smart atlas for pediatric bone age estimation that automatically identifies the closest Greulich & Pyle standard to a patient's hand radiograph. Provides bone age predictions within milliseconds, displays patient position relative to atlas standards, and generates auto-populated customizable reports. Achieved mean absolute error of 4.3 months (vs 7.0 months for unaided radiologist) and won 1st place in the RSNA Inaugural Machine Learning Challenge 2017. Available with 7-day free trial for individual radiologists and smaller practices.

Quantifiable outcome

• AUC of 0.89 (0.87-0.90) in community imaging dataset, 0.87 (0.85-0.88) in CaMos dataset, 0.82 (0.79-0.85) in Osteoarthritis Initiative dataset
• +4 more outcomes

Named customers5 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

Integration2 records

AI capability3 records

Feature4 records

Partnerships

17 partnerships are on record, tiered core and minor.

• Cambridge Memorial HospitalcoreChannel Partner/ Reseller/ Distributor · 26 January 2024First hospital in Ontario to integrate Rho in routine clinical practice. Partnership enables proactive screening for low bone density in patients over 50 using routinely captured x-rays.
• CAN Health NetworkcoreStrategic or Co-development Partner · 19 October 2023CAN Health Network is a network of leading Canadian health organizations aiming to introduce new solutions into healthcare. Awarded 16 Bit the 2023 Impact Award for commercialization project at Sunnybrook. Partnership supports Rho's alignment with Quadruple Aim: improving population health, enhancing patient experience, improving provider satisfaction, and reducing cost of care.
• CaMos (Canadian Multicentre Osteoporosis Study)coreStrategic or Co-development Partner · 19 October 2023Research partnership with CaMos for manuscript published in JACR reporting Rho performance in three independent datasets. CaMos is a rich longitudinal cohort study of 6,539 women and 2,884 men used for training and validation of Rho algorithm.
• Clear Medical ImagingcoreChannel Partner/ Reseller/ Distributor · 25 April 2023One of the largest independent healthcare providers in Ontario partnered to offer Rho to patients. Partnership brings AI-powered osteoporosis screening to wide patient population through Clear Medical Imaging's radiology services.
• Sunnybrook Health Sciences CentrecoreStrategic or Co-development Partner · 16 March 2023CAN Health Network commercialization project evaluating Rho at Sunnybrook. In one month of collaboration, Sunnybrook screened 567 patients and identified 370 as high risk. Sunnybrook hosted Inovait's 4th Image Guided Therapeutics Symposium where 16 Bit presented results.
• Canadian Association of Radiologists (CAR)coreStrategic or Co-development Partner · 18 January 2023Collaborator on INOVAIT Focus Fund project for Rho commercialization and clinical evidence generation. 16 Bit participated in CAR 2023 Annual Scientific Meeting with 'Rho-deo' demo booth.
• Osteoporosis CanadacoreStrategic or Co-development Partner · 18 January 2023Collaborator on INOVAIT Focus Fund project focusing on clinical evidence generation and stakeholder evaluation to support widespread clinical adoption and reimbursement for Rho.
• Centre for Technology Adoption for Aging in the North (CTAAN)minorStrategic or Co-development Partner · 18 January 2023Collaborator on INOVAIT Focus Fund project for Rho commercialization with focus on product iteration and clinical evidence generation.
• GE HealthcarecoreChannel Partner/ Reseller/ Distributor · 9 August 2022Selected as 1 of 6 global companies for GE Healthcare's Canadian Edison AI Accelerator. Integration of Rho with GE's Edison Health Service platform for distribution to GE customers. GE highlighted 16 Bit's product in their post about the Edison Accelerator. Partnership enables widespread distribution alongside GE's healthcare technology infrastructure.
• Desjardins Startup-in-ResidenceminorStrategic or Co-development Partner · 28 March 2022Won first prize in Desjardins Startup-in-Residence Pitch competition. Program provides 8 months of personalized mentorship from business experts and entrepreneurs focused on key objectives for scaling startups.
• Plug and Play AlbertaminorStrategic or Co-development Partner · 17 March 2022Selected as 1 of 14 startups to join inaugural Alberta cohort of Plug and Play Accelerator for Health program. Benefited from 12 weeks working with partners, investors, and mentors focusing on sales, reimbursement, fundraising, and business scaling.
• Layer 6 AIminorStrategic or Co-development Partner · 12 August 2020AI technology partner in COVID-19 prediction tool project combining high-quality clinical data from COVID-19 hospital patients.
• Vector InstituteminorStrategic or Co-development Partner · 12 August 2020AI research partner in COVID-19 prediction tool project providing expertise in artificial intelligence analysis.
• RocheminorStrategic or Co-development Partner · 12 August 2020Pharmaceutical partner in COVID-19 prediction tool project combining clinical data with AI tools for patient care prediction.
• Creative Destruction LabminorStrategic or Co-development Partner · 30 June 2019Graduated from Creative Destruction Lab accelerator program which includes mentorship from entrepreneurs and angel investors and business development support.
• H2i (Health Innovation Hub)minorStrategic or Co-development Partner · 24 October 2017University of Toronto's Health Innovation Hub awarded Student Entrepreneurial Fellowship to founders Alex and Mark. H2i has mission to educate, enable, partner, and facilitate early stage entrepreneurs in commercialization of health matters.
• Carbon60minorOthersPartner listed on company partners page.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• HeartFlow: HeartFlow is a comparable growth-stage SaMD company using AI on imaging data (CT angiography) to drive downstream clinical decisions. It shares 16 Bit's playbook of turning AI imaging analysis into a reimbursement-supported diagnostic workflow, though in cardiovascular rather than bone health.
• Paige.AI: Paige.AI develops FDA-authorized AI for pathology imaging with a similar regulatory-first, clinical-validation-led commercialization model. It is comparable as an AI-first SaMD company that used breakthrough-device-style authorizations to anchor enterprise hospital sales, though in digital pathology rather than radiology.

Direct peers

• Qure.ai: Qure.ai develops deep-learning algorithms for medical imaging, including chest x-ray triage and opportunistic detection of findings on plain radiographs. It is a direct competitor in AI-driven radiology workflow software with FDA clearances and enterprise hospital sales.
• Zebra Medical Vision (Nanox AI): Nanox AI (formerly Zebra Medical Vision) is a directly comparable imaging AI platform offering AI algorithms for opportunistic findings on CT and x-ray, including bone-related applications. Like 16 Bit, it sells AI-driven radiology software to hospitals and integrates with PACS workflows.
• Aidoc: Aidoc is a leading AI radiology workflow company with FDA-cleared algorithms for triage and detection across CT and x-ray, sold to hospital systems with PACS integration. It is comparable as a PACS-integrated imaging AI platform targeting enterprise radiology customers.
• Annalise.ai: Annalise.ai offers comprehensive AI-driven chest x-ray and CT interpretation, including bone-related findings. It is a direct peer in opportunistic AI-driven analysis of plain radiographs for clinically actionable findings, sold into hospital radiology workflows.

Broad incumbents

• GE Healthcare: GE Healthcare is both a strategic partner (Edison platform) and a broad incumbent in medical imaging equipment, PACS, and AI-enabled imaging IT. It competes indirectly because hospitals may default to GE-native AI rather than third-party apps like Rho.
• Hologic: Hologic is the dominant manufacturer of DXA bone densitometry systems used to diagnose osteoporosis. Although Hologic sells hardware rather than AI software, it is a key incumbent in the bone-health screening workflow that Rho aims to feed with downstream referrals.
• Viz.ai: Viz.ai is a leading FDA-cleared AI platform for clinical workflow and triage, anchored in stroke but expanding into other specialties. It is comparable as a higher-revenue, better-capitalized imaging AI company selling enterprise SaaS into hospitals with regulatory clearances.
• DeepHealth (RadNet): DeepHealth, acquired by RadNet, is an AI-powered imaging diagnostics platform with FDA-cleared algorithms integrated across radiology workflows. It is comparable as a commercialized, scaled imaging AI vendor selling into hospital and outpatient imaging centers.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/16bit-inc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds3 records

Investors2 records

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 16 Bit