Data Update: October 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 September 2025, the FDA released 16 new guidance documents, including 2 guidelines focused on the medical devices.

• Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff

This guidance describes a risk-based approach to establish confidence in the automation used for production or quality systems, identify where additional rigor may be appropriate, and various methods and testing activities that may be applied to establish computer software assurance. FDA's goal is to help manufacturers produce high quality medical devices while complying with the Quality System regulation, 21 CFR Part 820.

• Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases and other threats. FDA is issuing this final guidance to describe the factors we intend to assess when deciding to issue an enforcement policy regarding test manufacturers' offering of certain unapproved in vitro diagnostic tests during a future relevant declared emergency under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

New Device Approvals/Clearances

In September 2025, FDA approved 3 De Novo device with a review time of 240 days, 4 PMA devices averaging 466 review days, and cleared 259 devices via the 510(K) pathway with an average review time of 139 days. Below, we spotlight the groundbreaking technologies that have successfully advanced through the regulatory process:

• Essilor Stellest (DEN250016) - 150 review days

The FDA has authorized marketing of Essilor Stellest spectacle lenses by EssilorLuxottica, allowing the first eyeglass lenses capable of slowing pediatric myopia progression to be sold in the U.S. The lenses were approved through the FDA’s de novo premarket review pathway after being granted breakthrough device designation in April 2021. The approval was based on clinical study data that showed a 71% reduction in spherical equivalent refraction and a 53% reduction in eye elongation at 24 months, according to the FDA. While there were no serious adverse events, some study participants reported blurs and halos.

• Biolinq Shine Autonomous Time-in-Range Microsensor (DEN240080) - 270 review days

Initially marketed to people with type 2 diabetes who are not dependent on insulin, Biolinq Shine is the first wearable biosensor integrating glucose, activity, and sleep information in a single device with autonomous operation. A patch on the forearm provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. Additional insights, such as activity and sleep trends, are available through a mobile app.

• KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (DEN240067) - 301 review days

US FDA has granted De Novo Classification Request for the CytoCell® KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax's first-in-class menin inhibitor, REVUFORJ® (revumenib). Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukaemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and paediatric patients one year and older.

• FDA cleared 26 AI/ML-enabled devices through the 510(K) pathway, including 19 Radiology devices, 4 Cardiovascular devices, 2 Neurology device, and 1 Gastroenterology & Urology device