Data Update: November 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 October 2025, the FDA released 7 new guidance documents, including 1 guideline focused on the medical devices.

• Quality Management System Information for Certain Premarket Submission Reviews

The Food and Drug Administration (FDA or agency) is issuing this draft guidance to provide guidance to industry and FDA staff about the expectations for quality management system regulation (QMSR) requirements for premarket submissions once the final rule amending 21 CFR part 820 goes into effect. The medical device current good manufacturing practice (CGMP) requirements of the QMSR have been updated to align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device quality management systems (ISO 13485:2016). When final, this guidance is intended to assist medical device manufacturers in preparing and maintaining the Quality Management System (QMS) and other information required in premarket submissions stemming from the QMSR.

New Device Approvals/Clearances

In October 2025, FDA approved 4 De Novo device with a review time of 502 days, 2 PMA devices averaging 559 review days, and cleared 310 devices via the 510(K) pathway with an average review time of 135 days. Below, we spotlight the groundbreaking technologies that have successfully advanced through the regulatory process:

• ProSense™ System (DEN220077) - 1,080 review days

The FDA's approval requires IceCure to conduct a post-market surveillance study involving around 400 patients across 30 sites to gather additional data. Combined with adjuvant endocrine therapy, the treatment is indicated for women aged 70 and above with early-stage, low-risk breast tumours. The cryoablation procedure involves inserting a cryoprobe into the tumour under local anaesthesia, guided by ultrasound imaging.

• PainChek (PainChek Adult) (DEN240073) - 299 review days

PainChek's app is the first FDA-approved device for pain assessment in the US. The PainChek app is available on smartphones and tablets and combines an artificial intelligence pain assessment tool with the numerical rating scale to allow accurate and consistent pain assessment for patients living with reduced ability to self-report pain. The device has attained regulatory clearance in Australia, Canada, the European Union, New Zealand, Singapore, Malaysia and the UK.

• Modius Lean (DEN240076) - 303 review days

Modius Lean is a non-invasive, home-use neurostimulation medical device intended to support weight management alongside diet and exercise, in adults aged 22 years and older, who have a Body Mass Index of 27 kg/m^2 and greater. The clinical trial study results were published this March.

• Pulsenmore ES (DEN240074) - 324 review days

The single-patient use prescription device consists of the Pulsenmore ultrasound cradle, which connects to a patient’s smartphone, and the Pulsenmore application, which guides the patient through the self-scanning process. Once the self-scan is completed, health care providers are then able to review the captured video clips, which are securely transmitted to a web-based dashboard for interpretation. Based on these scans, clinicians are able to assess fetal heartbeat, fetal movements, and amniotic fluid volume. The FDA authorization was granted following completion of a multicenter trial (NCT05329077).

• FDA cleared 11 AI/ML-enabled devices through the 510(K) pathway, including 9 Radiology devices, 1 General & Plastic Surgery device, and 1 Gastroenterology & Urology device