Data Update: September 2025

We're here to keep you up to speed with the latest on FDA device approvals, regulatory updates, and emerging adverse event trends. Each edition is designed to give you clear, actionable insights—so you can stay informed, proactive, and ahead in the evolving landscape of medical device regulation.

Let's take a look at what's new this month.

New Guidance Documents

In August 2025, the FDA released 5 new guidance documents, including 2 guidelines focused on the medical devices.

• Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions

This guidance document provides the FDA's recommendations on animal studies to support premarket notification (510(k)) submissions for dental bone grafting material devices. The recommendations may assist manufacturers in complying with some special controls for these devices. The guidance also provides recommendations that may aid in the reduction of the total number of animals used to support a submission, supports the 3Rs of replace, reduce and/or refine animal use, and encourages manufacturers to consult FDA if they wish to use a non-animal testing method they believe is suitable. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of dental bone grafting material device submissions.

• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

The FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness. This guidance recommends that a PCCP describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. The FDA reviews the PCCP as part of a marketing submission for an AI-enabled device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. The recommendations in this guidance apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways. The recommendations in this guidance build on FDA's longstanding commitment to develop and apply innovative approaches to the regulation of AI-enabled devices.

New Device Approvals/Clearances

In August 2025, FDA approved 1 De Novo device with a review time of 229 days, 6 PMA devices averaging 217 review days, and cleared 257 devices via the 510(K) pathway with an average review time of 147 days. Below, we spotlight the groundbreaking technologies that have successfully advanced through the regulatory process:

• Delphi-MD System (DEN250002) - 229 review days

Delphi-MD platform enables detection of brain abnormalities across a wide range of conditions, including stroke, dementia, and Parkinson's Disease. Delphi-MD was granted FDA Breakthrough Designation Device status twice, the first for the detection of patients at risk for stroke and dementia and the second for detection of NPH and prediction of treatment response to ventriculoperitoneal shunt (VPS) surgery.

• Globe® Pulsed Field System (P240044) - 253 review days

FDA granted PMA for the Globe Pulsed Field Ablation (PFA) System, along with 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping software in June 2025. The Globe system is the only integrated platform that combines high-density mapping and PFA in a single device. It features a 122-electrode spherical array designed to deliver rapid, effective, and durable single-shot pulmonary vein isolation (PVI), helping to streamline workflows.

• Idylla CDx MSI Test (P250005) - 177 review days

The Idylla™ CDx MSI Test aids in identifying eligible microsatellite instability-high (MSI-H) colorectal cancer (CRC) patients, who may benefit from treatment with OPDIVO® (nivolumab) alone, or in combination with YERVOY® (ipilimumab), as established in the CheckMate-8HW trial (NCT04008030). Designed for use on the Idylla™ Platform, the Idylla™ CDx MSI Test qualitatively detects a panel of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for detection of MSI in CRC tissue samples. The Test runs in a single-use cartridge, requiring less than three minutes of hands-on-time and delivering straightforward results in under three hours.

• MMR IHC Panel pharmDx (Dako Omnis) (P250004) - 178 review days

This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb's Opdivo® (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy® (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

• Embrace Hydrogel Embolic System (P250003) - 180 review days

According to the company, Embrace HES consists of two low-viscosity aqueous liquid precursors that interact to crosslink intravascularly when simultaneously injected into blood vessels during the embolization procedure to form a soft, polyethylene glycol (PEG) hydrogel. The liquid embolic is designed to deeply penetrate the tumor vascular bed, crosslink, and stop blood flow, stated the company. The PMA for the Embrace HES was granted based on results from a prospective, randomized, multicenter pivotal study (NCT04523350).

• FDA cleared 19 AI/ML-enabled devices through the 510(K) pathway, including 13 Radiology devices, 3 Cardiovascular devices, 1 Anesthesiology device, 1 Pathology device, and 1 Obstetrics/Gynecology device