In this webinar we will explore the available regulations, case studies of warning letters related to claims, and how you can avoid the "label" by the FDA of adulterated and misbranded. Medical device ...

Basics and Beyond - Keeping Up with FDA Medical Device Submission Programs and Pilots” session MEDevice Boston 2026 on August ...

Several prominent members of the medical device industry, including its largest trade group, have voiced their concerns about a new guidance document released by the US Food and Drug Administration ...

Like many in the medtech industry, I was initially optimistic when FDA announced its revised guidance on wearable wellness devices. For years, the industry has called for clearer, more predictable ...

The agency said it closed its warning letter against Whoop after the wearable company modified its Blood Pressure Insights ...

BTIG analyst Ryan Zimmerman said while the increase in approvals is promising, longer decision times may have financial implications.

The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a ...

Kumar could face more than 100 years in jail if sentenced to the maximum on all charges.

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...