Complex vascular procedures demand more from delivery systems. Learn how sheath design, materials, and surface performance influence navigation, vessel protection, and device deployment.

As vascular procedures grow more complex, low-pressure balloons are increasingly relied on for tasks that demand flexibility rather than force. These compliant structures are designed to conform to ...

DSM Biomedical offers a variety of different medical-grade Ulteeva Purity® fibers for numerous medical applications, including medical devices in orthopedic trauma, medical implants, and other uses in ...

Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

On Dec. 8, 2021, CEN, the European standards body, released an amendment to the European edition of the medical device risk management standard, EN ISO 14971:2019, amendment A11:2021. This edition, ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...