Welcome to the latest issue of the NyquistAI Newsletter! Each month, we deliver clear, practical updates on FDA device approvals, regulatory developments, and key adverse event trends. Our goal is to help you stay informed, proactive, and ahead of the curve in the ever-changing world of medical device regulation.

Let’s dive into this month’s highlights!

New Guidance Documents

In June 2025, the FDA released 14 new guidance documents, including 2 guidelines focused on the medical device premarket submission.

• Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

This guidance provides information on frequently asked questions regarding the transfer or sale of a premarket notification (510(k)) clearance from one 510(k) holder to another.

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This guidance also addresses FDA’s recommendations regarding section 524B of the FD&C Act for cyber devices. This document supersedes the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” issued September 27, 2023.

New Device Approvals/Clearances

In June 2025, FDA approved 3 De Novo devices with an average review time of 298 days, 3 PMA devices averaging 360 review days, and cleared 300 devices via the 510(K) pathway with an average review time of 148 days. Below, we spotlight the groundbreaking technologies that have successfully advanced through the regulatory process:

• APO-Easy Genotyping kit (DEN240032) – 356 review days

The APO-Easy® Genotyping kit is a qualitative polymerase chain reaction (PCR) test intended for the detection of two single-nucleotide polymorphisms (SNPs), rs429358 and rs7412. The APOE genotype information provided by the test is used with other laboratory and clinical information to aid in the evaluation of the risk of developing late-onset Alzheimer’s Disease (AD) in patients presenting with cognitive impairment and/or with predisposing risk factors. It received its CE marking under EU IVDR in August 2024.

• Oxiplex® (DEN240038) – 330 review days

Oxiplex is a safe, easy-to-use, absorbable, clear viscoelastic gel applied to tissues and surrounding anatomy during surgery, immediately prior to closure. In spine surgery, Oxiplex acts as a temporary physical barrier between adjacent tissues and has been shown in multiple peer-reviewed publications to reduce postoperative leg pain and neurological symptoms. Oxiplex gel has been available outside the United States since 2002 and has been used in more than 750,000 spine procedures worldwide for postoperative adhesion prevention.

• COAPTIUM Connect with TISSIUM LIGHT (DEN240066) – 208 review days

Peripheral nerve injuries affect hundreds of thousands of patients annually and are typically repaired using microsurgical sutures. However, this approach presents limitations – including technical complexity, risk of additional trauma, and variable outcomes. COAPTIUM® CONNECT addresses these challenges by offering a reproducible, atraumatic sutureless alternative that preserves nerve integrity and simplifies the coaptation process. Currently, COAPTIUM® CONNECT is the only FDA-authorized system designed for atraumatic sutureless nerve coaptation.

• FDA cleared 23 AI/ML-enabled devices through the 510(K) pathway, including 17 Radiology devices, 1 Hematology device, 1 Gastroenterology & Urology device, and 4 Cardiovascular devices.