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

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FDA Publishes Draft Guidance on Medical Device Cybersecurity

FDA has published a draft of the guidance document that it has developed to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions for medical devices.  This guidance document is intended to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and

 
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Monash University in Australia Starts Test of Direct-to-Brain Visual Prosthesis Chips

Engineers from the Monash Vision Group (MVG) have begun trialling the ASICs for a direct-to-brain visual prosthesis that is expected to enter human clinical trials in 2014. The prosthesis will consist of a tiny camera mounted into a pair of glasses, which acts as the retina; a pocket processor, which takes the electronic information from

 
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John Hopkins Researcher Develops New Early-Warning Seizures Detector with Low False-Positive Rate

Johns Hopkins’ Sridevi V. Sarma, an assistant professor of biomedical engineering, has devised new seizure detection software that, in early testing, significantly cuts the number of unneeded brain-stimulation therapy that an epilepsy patient would receive. According to Sarma, “These devices use algorithms—a series of mathematical steps—to figure out when to administer the treatment,” Sarma said. “They’re

 
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Boston Scientific to Acquire Cameron Health for $150M Up-Front + $150M Upon FDA Approval

Boston Scientific announced the exercise of its option to acquire Cameron Health.  Cameron Health developed the world’s first and only commercially-available subcutaneous implantable cardioverter defibrillator – the S-ICD® System that I blogged about a few weeks ago. The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150

 
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iPacemaker Implantable Pacemaker/ICD Database for the iPhone

My friend and colleague Dr. Irit Yaniv alerted me to this iPhone app that was just released.  It is an implantable pacemaker and defibrillator database that, according to its author, displays up to 70 parameters for each model, includes battery and longevity data, and links directly to product manuals.

 
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BetaBatt’s Modern Betavoltaic Cells to Power Active Implantable Devices

Image Credit: University of Rochester Nuclear energy cells that converted the impact of the β-particles on a p-n junction were developed in the 1970s.  One example was CCC’s atomic pacemaker, which was powered by a promethium-147  McDonell-Douglas Betacel 400. Lately, BetaBatt Inc. of Houston, TX licensed beta-voltaic technology developed  at the University of Rochester to develop an

 
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Glucose Fuel-Cell-Powered Implantable Devices

  My friend, Dr. Alain Ripart – the Chief Scientific Officer at Ela Medical (now part of Sorin) showed me this interesting contraption from his personal collection.  It is an experimental glucose-powered pacemaker developed in the 1970s.  It generated electricity by acquiring its fuel (glucose) directly from a living body to generate enough current to charge two NiCd cells

 
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