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

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OT: New Book on Ultraviolet Photography

My new book “Exploring Ultraviolet Photography: Bee Vision, Forensic Imaging, and Other Near Ultraviolet Adventures with Your DSLR” is now available on Amazon for pre-order. In this book, I will show you how to select equipment that allows you to capture otherworldly UV images. You’ll learn how to use filters that block visible light and

 
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Destron Fearing Bio-Thermo Pet ID + Temperature Sensor Implantable Tag

“Bio-Thermo” implantable tags combining animal ID and temperature measurement are manufactured by Destron Fearing (www.destronfearing.com).  The Bio-Thermo tags were originally produced by a company named “Digital Angel” in Delray Beach, FL. The Bio-Thermo tag is covered under a 2006 US Patent No. 7,015,826 “Method and Apparatus for Sensing and Transmitting a Body Characteristic of a

 
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Keynote Lecture on Electroceuticals Presented at 2014 VLSI Symposium in Taiwan

My daughter Shanni and I just came back from Hsinchu, Taiwan where I was invited to deliver a keynote lecture at the 2014 International Symposium on VLSI Design, Automation and Test. The lecture was titled “Electroceuticals – Replacing Drugs by Devices Enabled through Advanced VLSI Technologies”  Here is the abstract:  Electroceuticals are medical devices that

 
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St. Jude’s Protégé Upgradeable Neurostimulator Receives FDA Approval

St. Jude Medical today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates.  According to the press release: Chronic pain sufferers implanted with

 
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Pacesetter’s 1973 Rechargeable Pacemaker

Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA.  There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation: I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it

 
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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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Medtronic Performs First Human Implant of its Micra Leadless Pacemaker

  According to the press release: At one-tenth the size of a conventional pacemaker, and comparable in size to a large vitamin, the Micra TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once positioned, the pacemaker is securely attached to the heart wall and can be repositioned if

 
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Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system. According to the press release: KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population

 
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EnteroMedics Reports Maestro Obesity Study Showing 25% Reduction in Excess Weight

EnteroMedics reported new clinical trial data for its Maestro system, which is designed to treat obesity through vagus nerve stimulation. The company said that its Maestro RC system lost 25% of their excess weight, or 10% of their total body weight, after 18 months. Patients who received a sham implant lost 12% of excess weight,

 
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