A blog about what is new (and old) in the world of active implantable medical devices 

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Submitting AIMD System Applications to China’s State FDA

I just came back from Beijing where we are in the process of registering our AIMD systems.  The process if very different than submitting an application to a EU Notified Body or to FDA.  This is because China’s State FDA (S-FDA) doesn’t accept testing performed abroad.  S-FDA only accepts testing performed at one of the Chinese

 
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Greatbatch Submits Application for CE Mark for its SCS System

On January 20, 2014, Mass Device reported that Greatbatch filed a CE Mark application for its spinal cord stimulation system with German notified body TÜV SÜD America.  The spinal cord stimulation system comes from Greatbatch’s subsidiary, QiG Group. The company also applied for pre-market approval last month.  

 
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SecondSight Starts US Commercial Implants of Argus II Retinal Prosthesis

On Jan 29, 2014, Second Sight Medical announced that it had performed the first commercial implants of the Argus II visual prosthetic at the University of Michigan’s Kellogg Eye Center.  Second Sight plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete

 
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St. Jude Implants First US Patient with its Nanostim Leadless Cardiac Pacemaker

St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy.  The LEADLESS II pivotal trial is a prospective, non-randomized,

 
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St. Jude Medical Announces Q4 2013 Results: CRM Up 4%, Neuromodulation Up 2%

St Jude Medical announced that its Cardiac Rhythm Management sales increased 5 percent on a constant-currency basis over the fourth quarter of 2012.  Neuromodulation sales for the same period increased by 2%.  According to the press release: Cardiac Rhythm Management Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $705 million for

 
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Boston Scientific Announces Q4 2013 Results: CRM Up 3%

Boston Scientific announced that it has continued to improve performance in the company’s Cardiac Rhythm Management business, achieving revenue growth of 3 percent versus the prior year period on a constant currency basis from $457M to $468M.

 
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Reveal LINQ: Medtronic’s New Miniaturized Insertable Cardiac Monitoring System

Medtronic’s new Reveal LINQ Insertable Cardiac Monitor is a tiny implantable device that weighs less than three grams and is far less invasive than any previous loop recorder.  The figure above shows its diminutive size compared to the Reveal XT device – it is a full 87% smaller!  The Reveal LINQ is a leadless device that

 
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