Sabrina Wang

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Latest Posts › FDA Approval

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BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac...more

8/16/2018 / 510(k) RTA , Biotechnology , FDA Approval , Medical Devices

First Extended-Range Intraocular Lens Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tecnis Symfony Intraocular Lenses (IOL) for treating cataracts. According to Abbott, the Tecnis Symfony lenses are currently the only lenses in the United...more

7/21/2016 / FDA Approval , Food and Drug Administration (FDA) , Medical Devices

First U.S. Implant of St. Jude’s First-to-Market “CRT-D”

St. Jude Medical, Inc. recently announced the U.S. launch and the first U.S. implant of its Quadra Assure MP™ cardiac resynchronization therapy defibrillator (CRT-D). The Quadra Assura MP™ features St. Jude Medical’s...more

4/20/2016 / FDA Approval , Medical Devices

Roche Adds FDA-Approved HIV-1 Assay To Its Cobas® 6800/8000 Systems

Swiss biotech company Roche announced on December 21, 2015 that the FDA has approved the Cobas® 6800 and 8800 Systems from its Pleasanton, California-based Roche Molecular Diagnostics (RMD) for the Cobas® HIV-1 viral load...more

1/12/2016 / FDA Approval , HIV , Medical Devices

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