Evidence map›Paper›PMID 39881094›Full record

ArticleJournal of imaging informatics in medicine2025

Medical Imaging Data Strategies for Catalyzing AI Medical Device Innovation.

Ravi K Samala, Brandon D Gallas, Ghada Zamzmi, Krishna Juluru, Amir Khan, Catherine Bahr, Robert Ochs, Dorn Carranza, Jason Granstedt, Edward Margerrison and 1 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of imaging informatics in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ravi K SamalaOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Ravi.Samala@fda.hhs.gov.ORCID http://orcid.org/0000-0002-6661-4801
Brandon D GallasOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Ghada ZamzmiOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Krishna JuluruDigital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Amir KhanOffice of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Catherine BahrDigital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Robert OchsOffice of Product Evaluation and Quality, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Dorn CarranzaOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Jason GranstedtOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Edward MargerrisonOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Aldo BadanoOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Continuous and consistent access to quality medical imaging data stimulates innovations in artificial intelligence (AI) technologies for patient care. Breakthrough innovations in data-driven AI technologies are founded on seamless communication between data providers, data managers, data users and regulators or other evaluators to determine the standards for quality data. However, the complexity in imaging data quality and heterogeneous nature of AI-enabled medical devices and their intended uses presents several challenges limiting the clinical translation of novel AI technologies. In this commentary, we discuss these challenges across different characteristics of data, such as data size, data labels, data diversity, data sequestration and reuse, and data drift. We discuss strategies around a data platform that incorporates protocols and checklists for ensuring data quality, tools and interactive guidelines that may help assess data diversity, study design and performance metrics for data usage and monitoring for data analytics. We envision this data platform to catalyze AI-enabled medical device innovation by providing a more efficient development and evaluation environment for bringing safe and effective AI technologies to the clinic.

Indexed as

Artificial IntelligenceDiagnostic ImagingEquipment and SuppliesHumansInventionsArtificial intelligenceData qualityMedical deviceMedical imaging dataSustainability

Identifiers

PMID39881094
PMCPMC12701115

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.