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  1. Recently-Approved Devices

Device Trial Participation Snapshots

Device trial participation snapshots aim to provide consumers and health care professionals with key information about clinical trials that supported the FDA’s approval of new medical devices. The Center for Devices and Radiological Health (CDRH) is piloting this approach to highlight certain information about the intended uses of the device, its benefits and risks, and the diversity of participants in clinical trials for certain new medical devices. This is part of an overall FDA effort to increase transparency around clinical trials for medical products and diversity in clinical trial participation.

Device trial participation snapshots may provide helpful information for an individual’s discussions with their health care provider and decisions about their health care. This supports CDRH’s overall efforts to advance health equity. We hope this information helps promote continued dialogue on representation of different groups in clinical trials. 

CDRH began posting device trial participation snapshots in October 2024 and is seeking comments from the public. The last day to submit comments is January 13, 2025.

Information Provided In Device Trial Participation Snapshots

Each device trial participation snapshot provides:

  • general information about what the device is, how it works, when it can be used, and benefits and risks of use,
  • who was represented in clinical studies of new medical technology (demographics including sex, age, race, ethnicity), and
  • whether there were any reported differences in the benefits and risks in different groups.

Limitations of Device Trial Participation Snapshots

Device trial participation snapshots are one tool for consumers to use when discussing the benefits and risks of using a device with their health care provider. Do not rely on these snapshots alone to make decisions about medical care.

  • Snapshots are not a substitute for advice from your health care provider.
  • Snapshots aim to provide consumer-friendly information about the clinical trials supporting approval of new medical devices, including the diversity of participants in clinical trials.
  • When known, snapshots include information on how the device worked in different groups of people in the clinical trial. It is not always possible to make conclusions about these differences when evaluating small numbers of participants in a particular group.

Frequently Asked Questions

Date of Original Approval  Device Name FDA Premarket Approval (PMA) Number Category
04/17/2024 Lumicell Direct Visualization System (DVS) P230014 General & Plastic Surgery
05/06/2024 Esprit BTK Everolimus Eluting Resorbable Scaffold System P230036 Cardiovascular
06/06/2024 Lacrosse NSE ALPHA Coronary Dilatation Catheter P230026 Cardiovascular
06/08/2024 Cordella Pulmonary Artery Sensor System (CorPASS) P230040 Cardiovascular
07/02/2024 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System P220030 Ophthalmology

Related Information

Recently-Approved Devices

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