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
A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans. ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform
I’ve been receiving tons of e-mail today from well-meaning friends to tell me about a major story in the news: “Hacker Found Dead Before Revealing Pacemaker Hacking Secrets” Actually, the major news outlets just picked up the story. Ethical hacker Barnaby Jack was found dead on July 25, 2013. In any case, the media is
With the popularization of space tourism, I would hereby like to propose the addition of a clause to 45502-1 to be titled “Protection of the active implantable medical device from microgravity conditions“. I propose the following language: The implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed and constructed so that no irreversible
I have been honored with an invitation to present at the Fourth IEEE CASS Summer School on Wearable and Implantable Biomedical Circuits and Systems in Bogotá, Colombia (July 9 – 12, 2013). I will be giving two 1 hour and 20 minute talks on “A Practical Perspective on Developing Novel Commercial Active Implantable Medical Devices”.
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
Micromagnetic Stimulation as an Alternative to Electrical Stimulation for Implantable Devices? I don’t think so…
The following captured my attention in the announcement of the 11th World Congress of the International Neuromodulation Society, “Technology Transforming Chronic Illness Management.” From June 8 – 13, 2013: “Micro-Magnetic Stimulation (Monday, June 10) – John T. Gale, Ph.D., has demonstrated for the first time that deep brain stimulation with micro-magnets can activate brain cells
I received today a link to a very interesting article which plays on the fears of the public, and which I am sure will result in tough new regulations to our industry. The article discusses how IOActive researcher Barnaby Jack reverse-engineered a “pacemaker transmitter” (probably a programmer or a MICS module) to command ICDs within a 30
In this TED talk, Hugo Campos explains his frustration with the fact that his ICD collects data, but he – as a patient – is unable to access these data as a diagnostic tool to help make good choices about eating, exercise and other activities.
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
Scientists at the Fraunhofer Institute for Ceramic Technologies and Systems developed a magnetically-coupled motor/generator system that they claim is able to transcutaneously transfer 100 mW to an implant up to 50 cm away. In the external power-transfer module, a rotating magnet driven by an EC motor generates a magnetic rotary field. A magnetic pellet in
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
FDA released its PMA/Supplement approvals for January. The edited version below has been edited to include only AIMDs. It is not the full list, and should be used only for general information purposes.
Magnetic reed switches are used in active implantable medical devices as a simple way of placing the device in a known operational mode when a programmer is not available. For example, placing a magnet on a pacemaker sets it to VVI mode with a manufacturer-specified set of parameters. In other devices (e.g. implantable cardioverter/defibrillators), placing a
News from Stanford: Modelling Tissue as a Dielectric Shows Feasibility of Inductive Power Transfer at 1 GHz
Stanford Engineering assistant professor Ada Poon demonstrated a tiny, wirelessly powered, self-propelled medical device capable of controlled motion through blood. The device drives electrical current directly through the fluid, which in the presence of an external magnetic field creates a directional force that pushes the device forward. This type of device is capable of moving at