Physis
AI-driven smart atlas for pediatric bone age assessment
Software · Cloud SaaSCompany source
Company profile
About 16 Bit Inc
16 Bit Inc is a Canadian health AI company that develops breakthrough AI-driven Software as a Medical Device (SaMD) products focused on creating new moments of care through intelligent screening. The company's flagship product, Rho, is an opportunistic screening system that utilizes routinely captured x-rays to identify patients at risk of osteoporosis and low bone mineral density. Rho has received both Health Canada licensing and FDA De Novo Marketing Authorization, and is protected by U.S. Patent No. US11737704B2. The system can utilize 60-80% of x-rays captured during routine care and has the potential to impact 42 million individuals with low bone mineral density. 16 Bit's second product, Physis, is an award-winning AI-driven smart atlas for pediatric bone age estimation that has been validated by four independent peer-reviewed publications and has analyzed over 400,000 bone age studies globally. The company won first place in the 2017 RSNA AI Challenge for Pediatric Bone Age. 16 Bit's approach focuses on user-centric design that seamlessly integrates into existing clinical workflows and supports value-based models of care to improve healthcare quality while increasing revenue through intelligent screening. The company serves health systems, imaging centers, and healthcare providers with solutions designed to address critical gaps in population health screening.
Company description 16 Bit Inc official website
Primary marketPopulation Health & Healthcare Analytics
Commercial modelCommercial information available on request
Company presenceLinkedIn
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- low bone mineral density
- osteoporosis
- pediatric bone age assessment
Who it serves
- Health Systems
- Hospitals
- Imaging Centers
Deployment & integration
Cloud Saas deployment with recorded integration context.
Recorded integration context: GE Edison platform.
Geographic context
MarketsCanada · United States
Company sourceOfficial website
Company milestones
Platform expansion
FDA De Novo Marketing Authorization for Rho (April 2024). Cambridge Memorial Hospital first in Ontario to use proactive screening (January 2024). JACR publication (October 2023). CAN Health Network Impact Award (October 2023).
Partnerships
Recorded partners
- Amgen
- Cambridge Memorial Hospital
- CAN Health Network
- Clear Medical Imaging
- Digital Technology Supercluster
- GE Healthcare
- INOVAIT
- Plug and Play
- Sunnybrook
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Rho
AI-driven opportunistic screening system for low bone mineral density
Software · Cloud SaaSCompany source
Rho Direct
Cloud-based screening for low BMD on routine radiographs
Software · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Clinical impact of adopting an AI-driven opportunistic bone health screening software using routine X-ray.Skeletal radiology · Jun 1, 2026
Fracture risk scores using output from an opportunistic screen of low bone density from conventional X-ray.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · Feb 3, 2026
An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 2: Implementation Considerations and Harms.Canadian Association of Radiologists journal = Journal l'Association canadienne des radiologistes · Aug 1, 2024
An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 1 Foundational Knowledge.Canadian Association of Radiologists journal = Journal l'Association canadienne des radiologistes · Aug 1, 2024
Opportunistic Screening of Low Bone Mineral Density From Standard X-Rays.Journal of the American College of Radiology : JACR · Apr 1, 2024
Canadian Association of Radiologists White Paper on De-identification of Medical Imaging: Part 2, Practical Considerations.Canadian Association of Radiologists journal = Journal l'Association canadienne des radiologistes · Feb 1, 2021
Clinical validation
Clinical-trial records
Clinical Deployment and Validation of RhoNCT05245851 · Sponsor · COMPLETED
Regulatory
Regulatory records
RhoDEN230023 · De Novo · Apr 9, 2024
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
60-80% of routine x-rays can be utilized for opportunistic screening
Rho product capability
42 million potential lives impacted
individuals with low BMD in addressable market
4.265 months mean absolute error
Physis bone age estimation accuracy
Cambridge Memorial Hospital
First hospital in Ontario to proactively screen for low bone density using Rho
Clear Medical Imaging
Partnership to offer Rho screening to patients
Sunnybrook Health Sciences Centre
Rho commercialization project supported by CAN Health Network
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from 16 Bit Inc
Recent articles published on 16 Bit Inc's official website.
FDA Grants De Novo Marketing Authorization for Rho!
Read on 16 Bit IncCambridge Memorial Hospital is the first in Ontario to proactively screen for low bone density
Read on 16 Bit IncJournal of the American College of Radiology publishes the performance of Rho in three independent datasets
Read on 16 Bit Inc16 Bit awarded CAN Health Network 2023 Impact Award
Read on 16 Bit IncClear Medical Imaging Partners with 16 Bit to Offer Rho to Patients
Read on 16 Bit Inc07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Population Health & Healthcare Analytics
Companies providing AI-powered analytics for population health management, healthcare data integration and analysis, risk stratification, care gap identification, or value-based care analytics. Focuses on analyzing data across patient populations to improve outcomes at scale and enable data-driven decision-making across health systems.
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Expanded Company research is in development.
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Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.