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Business & Technology Briefs (03/2007)

Brief summaries of recent product and clinical developments in the device industry, including developments in Cardiac and Peripheral Devices, Miniature Robotic Devices, and Diabetes Management.

St. Jude Medical Inc.(St. Paul, MN) has implanted the first patient with its investigational Genesis Neurostimulation System, in a pilot study that will preliminarily evaluate if stimulating nerves near the spinal cord will control chronic chest pain caused by angina.

The study will be testing the Genesis system on patients 18 years of age or older who have been diagnosed...

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• By Marion Webb

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Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

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• By Natasha Barrow

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MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

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