News Medical

Medical Device Categories Explained

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
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Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...
Business Wire

Orthofix Announces Support for Continued FDA Class III Designation for Bone Growth Stimulators to Ensure Patient Safety and Therapy Efficacy

LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, announces support for the continued U.S. Food and ...
Nasdaq

Orthofix Supports FDA Class III Label Continuation for BGS

Orthofix Medical Inc. OFIX announced its support for the continuation of the FDA’s Class III designation for Bone Growth Stimulators (BGS) devices through a press release dated Feb 24. It is pledging ...