Radiology & Imaging AI
S

Subtle Medical

Deep learning software that enhances and accelerates medical image acquisition on existing scanners rather than detecting pathology. SubtlePET (FDA cleared 2018) and SubtleMR (2019) denoise and sharpen PET and MRI images, allowing faster and lower dose acquisition; SubtleHD (MR) cleared November 2025 and SubtleHD (PET) cleared May 2026 extend that with newer model architectures, with SubtleHD (PET) supporting all FDA approved radiotracers and, per the vendor, up to 75 percent faster PET imaging. A CT product has clearance pending. The company reports 11 FDA clearances, more than 25 peer reviewed publications, and deployment on more than 1,300 scanners, with customers including Mount Sinai, RadNet, and Radiology Partners. Raised $33 million in growth capital anchored by a Series C led by Morgan Stanley Expansion Capital in 2026.

Last VerifiedJuly 19, 2026
Founded
Headquarters
Menlo Park, California
Categories
radiology-and-imaging-ai
Indexed Products
SubtlePET, SubtleMR, SubtleHD (MR), SubtleHD (PET), Subtle-ELITE
Buyer Segments
Academic Medical Center, Large IDN, Community Health System
Assessment

Capability Axes

AI Capability
AI Centrality
A
Vendor Published

Deep learning reconstruction and denoising is the entire product. The software's function is to produce diagnostic quality images from faster or lower dose acquisitions, which is a model output, not a workflow wrapper.

Autonomy and Oversight Model
Not rated
Model and Technology Transparency
Not rated
Clinical and Operational Evidence
A
Vendor Published

More than 25 peer reviewed publications reported alongside FDA clearance validation, including SubtleHD (PET) validation across a range of accelerated low count acquisitions. Deployment scale is corroborated at more than 1,300 scanners with named customers including Mount Sinai, RadNet, and Radiology Partners. Graded on the existence and depth of peer reviewed evidence; this index does not re verify the underlying studies.

AI Safety and PHI Stewardship
Not rated
Regulatory and Compliance
HIPAA and BAA Posture
Not rated
Security Certifications and Trust Center
Not rated
FDA and Regulatory Status
A
Regulatory Filing

A reported 11 FDA clearances across PET and MR, with product level specificity and dates: SubtlePET in 2018, SubtleMR in 2019, SubtleHD (MR) in November 2025, SubtleHD (PET) in May 2026. A CT product is disclosed as clearance pending rather than described as cleared. Precise, per product, and does not overstate.

AI Governance and Bias Disclosure
Not rated
Integration and Deployment
EHR and Interoperability Depth
Not rated
Deployment Model and Data Residency
B
Vendor Published

Scanner and vendor agnostic by design, compatible with any brand of MRI scanner and PACS, and deployed on existing hardware without new capital equipment. Held back from A because specific data residency and tenancy commitments were not retrieved.

Commercial
Commercial Transparency
Not Rated
Vendor Published

No public pricing. Contact the vendor. Sold through enterprise imaging agreements with no published rate card.

Setting and Specialty Coverage
Not rated
Public Record

Announced Deployments

Publicly announced health system deployments and partnerships. This is a record of announcements, not an assessment of deployment success or scale.

Mount Sinai Health System
Subtle Medical imaging enhancement software in use
Radiology Partners
Subtle Medical imaging enhancement software in use
RadNet
Subtle Medical imaging enhancement software in use
Commercial

Pricing

Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.

Entry Price Pricing Basis BAA Tier Implementation Source
Contact the vendor
Enterprise imaging agreements Vendor Published

Sold through enterprise imaging agreements, typically scoped by scanner or site. No rate card published.

AI Health Index

An independent reference for evaluating AI vendors in healthcare. No vendor pays for inclusion, placement, or rating.

Index Status
Last index update
July 19, 2026
The AI Health Index is an editorial reference, not a regulatory body. Vendor data is verified against published sources and public regulatory filings. Figures labeled “Estimated” have not been confirmed by the vendor. See the Methodology page for evaluation standards and limitations.
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