In 1976, Congress enacted the Medical Device Amendments (MDA). This law, now part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), generally requires FDA clearance or approval before a new ...

Amazon (AMZN) is building custom AZ3 chips for Echo and Fire TV to run AI on-device for better security and performance.

The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the ...

The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal ...

Qosina’s line of Kynar barbed luer connectors come in various sizes and configurations and are kept in stock and ready for customer orders. Medical device makers pondering the materials and designs of ...

Amazon is developing its own AI chips for home devices, signaling a significant shift towards AI-powered gadgets. These ...

The downsizing of medical devices in critical care is improving patient treatment. More elegant and advanced, smaller medical devices are enabling medical professionals to deliver enhanced care in ...

In today’s world, digital threats are everywhere. They’re increasingly sophisticated in nature, making the security of company-owned and managed hardware more critical than ever. For businesses of all ...