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St. Jude Neurostimulation Products Get US Thumbs Up

 
• By Elizabeth Orr

St. Jude Medical announced important US FDA approvals for neuromodulation devices to treat chronic pain, Parkinson’s disease and essential tremor.

St. Jude Medical Inc.’s neurostimulation unit got a boost this week with two new US FDA approvals.

The first approval, announced Oct. 4, went to spinal cord stimulation system BurstDR, which is used to treat chronic pain patients. St. Jude says the physician-designed system uses intermittent “burst”...

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First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
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New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
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Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

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More from Policy & Regulation

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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