Company’s device treats atrial fibrillation, a heartbeat disorder that affects more than 59 million people worldwide ...

Class III medical devices are high-risk devices that are commonly used to sustain or support the life of a patient. About 10% of medical devices come under this category, ...

Developing Class III medical devices, those that are life-sustaining, life-supporting, or implanted, presents some of the major challenges in the healthcare industry. These high-risk medical ...

One percent of the 3000 medical devices approved by the FDA are Class III, high-risk medical devices sustaining or supporting life or capable of “unreasonable risk or illness or injury.” They require ...

A Unique Device Identifier (UDI) is an individualized alphanumeric signature associated with a single medical device. Since 2013, the Food and Drug Administration (FDA) has mandated the placement ...

Baird Medical is the first company to obtain a Class III medical devices registration certificate for MWA medical devices specifically indicated for thyroid nodules in China. For more information ...

The U.S. Food and Drug Administration reserves its Class I status for the most serious, life-threatening medical device problems. For comparison, between 2017 and 2020, Medtronic averaged about ...