Medical Device

Medical Device Imaging Core Lab

As an ISO Certified Imaging Core Lab, our Medical Device Imaging division provides specialized medical imaging core lab services for the clinical evaluation of Class I, II, and III medical devices across a broad range of therapeutic applications and regulatory pathways. Our board-certified, fellowship-trained radiologists combine subspecialty clinical expertise with extensive experience in the imaging-based assessment of medical devices, including implanted devices, stents, catheters, embolization and stroke devices, drug and biologic delivery systems, biopsy equipment, diagnostic software, artificial intelligence and computer-aided detection technologies, and other novel devices.

From early feasibility and proof-of-concept studies through pivotal clinical investigations supporting 510(k) submissions and Premarket Approval (PMA) applications, Intrinsic Imaging works with medical device manufacturers to develop scientifically rigorous imaging strategies capable of objectively evaluating device placement, technical performance, safety, durability, and clinical effectiveness.

Intrinsic Imaging provides comprehensive support throughout the medical device clinical trial lifecycle, including protocol development, imaging endpoint strategy, imaging charter development, modality selection, site and equipment qualification, standardized image acquisition, image quality control, reader training and qualification, centralized independent review, adjudication, quantitative analysis, and regulatory-ready data delivery. Our imaging expertise encompasses CT, advanced three-dimensional imaging and reconstruction techniques, radiography, ultrasound, DXA, nuclear medicine, and PET, with study-specific methodologies developed according to the device, anatomy, mechanism of action, and intended clinical endpoint.

As an ISO 13485-certified imaging core lab, Intrinsic Imaging applies a disciplined quality framework to medical device clinical investigations, with particular emphasis on traceability, reproducibility, standardized assessment, and the reduction of site and reader variability. By integrating regulatory experience, subspecialty physician expertise, sophisticated imaging methodologies, and rigorous quality systems, Intrinsic Imaging provides medical device sponsors with the scientific and operational infrastructure required to generate robust, objective imaging evidence throughout the medical device development and regulatory approval process.

Medical Device Imaging Division Highlights

Board-certified, fellowship-trained radiologists with medical device expertise.
Expertise in full complement of medical devices.
Expertise executing Class I, II, and III medical device trials in support of 510(k) and PMAs.
ISO 13485 certified for providing imaging core lab services on medical device trials.
Experts in protocol design and selection of imaging modalities best oriented towards the placement, assessment and evaluation of medical devices.
Modality expertise includes:
- CT, DXA, 3D techniques
- Nuclear medicine with PET
- Radiography (CR and DR)
- Ultrasound

Medical Device & AI Track

Bring Your Medical Device or AI Algorithm to Market

510(k), De Novo & PMA

Imaging endpoint support for Class I, II and III medical device trials, backed by ISO 13485 certification.

MRMC reader studies

Multi-reader multi-case design and execution for AI/CAD and SaMD — 55+ large MRMC studies completed.

Ground truth panels

Expert adjudication panels drawn from 750+ board-certified physicians establish reference standards.

FDA inspection readiness

Zero 483 observations across our FDA inspections, including CDRH.

Medical Device Imaging division AI & CAD Validation

Imaging Core Lab for 510(k), De Novo and PMA Submissions

Our medical device imaging core lab supports Class I, II, and III medical device trials from early feasibility through pivotal studies supporting 510(k), De Novo, and Premarket Approval (PMA) submissions, with imaging endpoint strategies designed around the device, anatomy, mechanism of action, and intended clinical endpoint.

AI, CAD and Diagnostic Software Validation

We support evaluation of AI software, CAD software, diagnostic software, PACS systems, and radiology viewers, including reader studies run through our Artificial Intelligence Division.

ISO 13485 Quality for Medical Device Trials

As an ISO 13485-certified imaging core lab, we apply a disciplined quality framework emphasizing traceability, reproducibility, standardized assessment, and reduced reader variability.

Medical Device Evidence Planning and Study Delivery

We build the imaging workstream around intended use, device risk, anatomy and the evidence needed for the sponsor’s chosen regulatory pathway. The regulatory authority determines submission requirements and authorization; our role is to generate independent, traceable imaging evidence.

Pathway or stage	Imaging planning	Evidence output
Early feasibility and IDE studies	Define imaging safety and performance measures; align acquisition with investigational use	Feasibility reads, quality findings and protocol-defined device assessments
510(k)	Align imaging evidence with the substantial-equivalence question and comparison design	Independent performance data and documented assessment methods
De Novo	Plan evidence for a novel device and its intended clinical use	Safety and performance imaging results with traceable review records
PMA and pivotal studies	Prespecify endpoints, blinding, adjudication and analysis populations	Central-review datasets and study documentation for submission support
Post-market studies	Maintain consistent surveillance and follow-up assessment	Longitudinal device findings and imaging endpoint data

From Endpoint Strategy to Database Lock

At planning, we review the protocol, imaging schedule, device mechanism and reference method. Startup covers charter approval, system configuration, site qualification and reader training. During execution, we manage image receipt, quality queries, independent reads and adjudication. Closeout reconciles missing examinations, resolves data queries and delivers the agreed datasets and supporting records.

A study-specific schedule identifies dependencies such as protocol approval, case availability, site readiness and reader qualification. Milestones and turnaround expectations are agreed for the actual scope rather than presented as a universal device-trial timeline.

Implants, Interventions and Diagnostic Devices

For implanted and interventional devices, imaging can evaluate positioning, deployment, patency, alignment, healing and anatomical or functional change. Acquisition and measurement rules define how device-related findings are separated from underlying disease.

Diagnostic devices and imaging software may require stand-alone performance evaluation, comparative reads or MRMC observer-performance studies. We align the reader population, comparator, reference standard and endpoints with intended use and the regulatory question.

Regulatory Collaboration and Traceable Deliverables

We support imaging-methodology input for FDA pre-submission discussions and responses to imaging-related questions. Deliverables include the imaging charter, qualification records, quality-control history, central assessments, adjudication records and reconciled data transfers. ISO 13485 provides a quality-management framework for these services; it is not a device clearance or a guarantee of approval.

Guidance for Sponsors

Physician-authored guidance from Intrinsic Imaging on imaging endpoints and trial design.

$Radiographs of a comminuted long-bone diaphyseal fracture$

Guidance for Sponsors · Volume 4, Issue 4 · 2026 Edition

Imaging Analysis and Operative Treatment of Diaphyseal Fractures

Fractures are among the most common reasons for an imaging examination, and imaging guides every stage of care: diagnosis, classification, reduction, fixation, detection of complications and confirmation of healing. Radiography, CT, MRI and bone scintigraphy each play a distinct role. For sponsors of orthopedic drug, biologic and device trials, the central challenge is that fracture union, the most commonly reported primary outcome, still has no universally accepted radiographic definition. Standardized scoring, consistent imaging schedules and independent central review turn a subjective judgment into a defensible endpoint.

Read the article

Illustration of the human spine and skeleton

Guidance for Sponsors · Volume 4, Issue 5 · 2026 Edition

Orthopedic Device Assessments: Medical Imaging Challenges in Clinical Trials

Orthopedic research spans joint reconstruction, spinal fusion and motion preservation, and biologics for cartilage, tendon and ligament repair. Regulators and payers expect rigorous quantitative and qualitative evidence of efficacy, safety and longevity, and imaging supplies much of it. Because investigational devices are often unlike anything imaged before, protocols must be built around the device itself: its engineering, materials, surgical technique and position. Advances in CT, metal-artifact-reduction MRI and radiostereometric analysis now allow earlier and more precise answers than ever.

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Guidance for Sponsors · Volume 5, Issue 11 · 2026 Edition

Quantitative MRI Imaging in Orthopedic Clinical Trials

Orthopedic trials have long depended on patient questionnaires and on radiographic joint space width, a measurement of what cannot be seen. Quantitative MRI measures cartilage, bone and soft tissue directly, in three dimensions, and can reveal biochemical change before structural loss occurs. Validated scoring systems for rheumatoid arthritis, consensus profiles for compositional cartilage imaging and metal artifact reduction techniques for implants have made MRI a practical endpoint across arthritis and device trials. This issue reviews those methods and what sponsors must standardize to use them well.

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More guidance: IVC Filter Imaging in Clinical Trials

Browse all Guidance for Sponsors →

Featured Case Study

Medical Device

IDE Pivotal Transcatheter Valve Trial

Structural heart
CT, fluoroscopy, echocardiography
Pre- and post-implant assessment

Challenge

A pivotal IDE trial of a transcatheter valve replacement system required standardized imaging for anatomical assessment and longitudinal evaluation of device performance. Precise anatomical sizing before the procedure was essential to device selection and patient safety, while consistent core lab review of post-implant imaging over extended follow-up was required to document device performance, positioning, and durability. Measurements taken at different timepoints and by different readers had to remain directly comparable, and every assessment needed to satisfy the evidentiary standard of a PMA submission.

Read the case study

View all case studies

More Medical Device case studies

Frequently Asked Questions

Which regulatory pathways does Intrinsic Imaging support?

We support 510(k), De Novo and PMA submissions for Class I, II and III medical devices.

Which medical device types has Intrinsic Imaging evaluated?

Our experience encompasses implanted medical devices, stents, catheters, embolization and stroke medical devices, drug delivery medical devices, biopsy equipment, biologics, and AI/CAD/diagnostic software.

Is the Intrinsic Imaging core lab ISO 13485 certified?

Yes. Our ISO 13485 certification covers the provision of imaging core lab services for medical device trials.

Planning a medical device trial? Reach out!

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