The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms.

Micro molding demands tight tolerances for precise parts in medical, electronics, and micro-systems. Vertical integration ...

Surgical navigation and robotic systems are not novel technologies, but the market continues to grow in the United States.

The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical ...

Explore two studies that indicate for a properly-assembled vial containment system, good CCI performance can be achieved with ...

The Ophir® SP920 USB 3.0 Silicon CCD High Resolution Beam Profiling Camera is designed to accurately capture and analyze wavelengths from 190 nm – 1100 nm, with enhanced sensitivity at 1070 nm. The ...

Laser welding is crucial for joining delicate parts in medical devices. However, welding thin wires of materials like stainless steel, nitinol, or titanium presents challenges due to their ...

"Forever chemicals" known as per- and poly-fluoroalkyl substances (PFAS) have raised significant concerns due to their persistence in the environment and potential health risks. These man-made ...

Despite wide utility in medical device applications, silicone is more of a niche material than thermoplastics, so general knowledge about its types, properties, and manufacture for use in these ...

Commercializing a drug-device combination product is a complex challenge to handle alone. Even though a variety of auto-injectors, pen injectors and wearable devices already exist, each one may react ...