The FDA is rolling out AI tools agency-wide by June 30, 2025, to streamline scientific reviews and reduce task time from days to minutes.

The FDA is modernizing the 510(k) Premarket Notification Program with new submission pathways, digital tools, and updated guidances to enhance medical device safety and effectiveness.

Medtronic has announced FDA approval of its Omniasecure defibrillation lead, a device that connects to implantable cardioverter...

The FDA has approved nearly 1,000 AI-enabled medical devices in the past decade, marking a significant shift toward smarter, more efficient, and personalized healthcare technologies.

Medtronic’s Simplera Sync glucose sensor has been FDA-approved for use with its 780G insulin pumps, marking a key step in the company’s push to grow its diabetes business through smarter, more integrated insulin delivery.

The FDA issued an early alert for BD’s PowerPICC catheters due to cracking and leakage risks, prompting a recall after reports of 10 serious injuries linked to material fatigue.

Medtronic has filed for FDA clearance to make its MiniMed 780G insulin pump interoperable with glucose sensors developed by Abbott, a...

Properly classifying your medical device is a crucial first step in the FDA approval process, as it determines regulatory requirements, timelines, and the appropriate pathway for market entry.

The FDA 510(k) review process follows four main stages—Acknowledgment, Acceptance, Substantive Review, and Decision Letter—each with specific timelines and expectations that determine whether a device is cleared for market.

Precision Neuroscience has received FDA clearance for its Layer 7 Cortical Interface, a brain implant that can be used for up to 30 days to map brain activity, marking a key step toward developing its wireless brain-computer interface system.

A robust Quality Management System (QMS) is essential for medical device manufacturers to ensure compliance with regulatory standards, improve product quality, and manage risk throughout the product lifecycle.

Understanding whether your medical device qualifies for the 510(k), PMA, or De Novo FDA pathway is crucial for ensuring a smooth, compliant market entry based on its risk level, novelty, and intended use.

Ceribell has gained FDA 510(k) clearance to use its Clarity seizure detection algorithm on pediatric patients aged one year and older....

The enactment of the 1976 Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic (FD&C) Act first gave the FDA authority to regulate medical devices.

Healthcare professionals reviewing protocols, reflecting the FDA's commitment to safety and collaboration in medical advancements.

A gloved hand holds a syringe filled with yellow liquid, injecting it into a red apple alongside two other syringes containing different...

A Design History File (DHF) is a crucial component of medical device development.

Medical devices must undergo extensive testing before being developed and approved to guarantee patient safety and efficacy.

This article will guide you through developing a risk management plan for medical devices, focusing on risk analysis.

The FDA has 3,500 jobs on the chopping block, which could hinder cybersecurity oversight, Democrats said during a subcommittee hearing.