medical devices

The FDA is inviting medical device developers to participate in the READI-Home Innovation Challenge, seeking proposed solutions for home-use medical technologies that reduce hospital readmissions, with selected participants receiving direct regulatory feedback to refine their designs.

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

As hospitals fill with wireless devices—from patient monitors to smartphones—radio frequency interference threatens medical device performance and patient safety. This article explores the critical testing methodologies, regulatory requirements, and risk management strategies manufacturers need to ensure their wireless medical devices work reliably in today's crowded spectrum environments.

FDA device clearance times remain lengthy—averaging 140–175 days, far beyond the 90-day goal. Staffing cuts and process shifts fuel delays, while underused third-party review programs offer a potential shortcut for manufacturers seeking faster approvals.

The U.S. Food and Drug Administration (FDA) has recently updated its list of medical devices that have received market authorization under its Breakthrough Devices Program.

The U.S. Food and Drug Administration (FDA) has released data that it says affirms the safety of certain per- and polyfluoroalkyl substances (PFAS) used in medical devices.

The U.S. Food and Drug Administration (FDA) has reportedly sent warning letters to several medical device manufacturers for violations of its device marketing and good manufacturing practices requirements.

As connected medical devices become more integral to patient care, ensuring their cybersecurity is critical to both patient safety and regulatory compliance. This article explores how the IEEE 2621™ standard and its associated certification program provide a structured, standards-based approach for engineers to design, validate, and secure these devices throughout their lifecycle

The United Kingdom has recently implemented strict regulations applicable to the post-market surveillance (PMS) of medical devices.

Staff at the U.S. Food and Drug Administration (FDA) are reportedly struggling to meet application review deadlines for medical device and tobacco products due to recent staff reductions.