Image Credit: Neural Implant Podcast by Ladan Jiracek
I don’t know how I’ve missed it, but now that I found it, I’m hooked! The Neural Implant Podcast hosted by Ladan Jiracek presents engaging conversations with the people driving innovation in neuroprosthetics, brain machine interfaces, and brain implants.
Researchers recently uncovered a suite of vulnerabilities (SweynTooth) related to the Bluetooth Low Energy (BLE) protocol that could impact medical devices that contain the affected SDKs of system-on-a-chip (SoC) BLE modules.
According to the researchers at the Singapore University of Technology and Design, SweynTooth captures a family of 12 vulnerabilities (more under non-disclosure) across different BLE software development kits (SDKs) of seven major system-on-a-chip (SoC) vendors. The vulnerabilities expose flaws in specific BLE SoC implementations that allow an attacker in radio range to trigger deadlocks, crashes and buffer overflows or completely bypass security.
SweynTooth vulnerabilities have been found in the BLE SDKs sold by major SoC vendors, such as Texas Instruments, NXP, Cypress, Dialog Semiconductors, Microchip, STMicroelectronics, Telink Semiconductor, and others. It is still unknown if any of these vulnerabilities affect any medical devices (including the newest implantable devices that have direct BLE connectivity with a patient’s cellphone).
Image Credit: Zurich MedTech
The FDA announced the acceptance of Zurich MedTech’s Sim4Life IMAnalytics and the field exposure libraries MRIxVIP1.5T and MRIxViP3.0T from the IT’IS Foundation as a Medical Device Development tool (MDDT). This is the first FDA-approved computational modeling Medical Device Development Tool.
IMAnalytics is a software platform for the safety evaluation of implantable devices in the Magnetic Resonance (MR) environment. It characterizes RF-induced heating at the distal electrodes of implantable devices, using a variant of the Tier 3 approach as defined in ISO/TS 10974. It is tailored for elongated lead structures by making use of the transfer function method described in Annex K of the same technical specification.
Panel: Unmet Needs Straight from the Heart of the Cardio Market
Thu. June 13| 11:00 AM – 11:45 AM | MD&M East | Medtech Hub, Booth #1669
The cardiovascular space has been among the most exciting in medtech in recent years, with advances like transcatheter procedures pushing the envelope when it comes to patient care. So where do we go from here? In this session, you’ll hear cardiologists and innovative companies in the cardiac space discuss where the next phase of innovation is in the field, what the next opportunities will be, and how engineers can move the needle.
For more information, please click here.
The U.S. Dept. of Homeland Security has issued a medical advisory warning of vulnerabilities and exploits against Medtronic’s implantable CRM devices and ancillaries. These exploits could allow an attacker to affect the functionality of the devices or intercept sensitive data.
The exploit affects Medtronic devices that use its Conexus telemetry protocol. Affected devices include all models of the Amplia CRT-D, Claria CRT-D, Compia CRT-D, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, Evera ICD, Maximo II CRT-D and ICD, Mirro ICD, Nayamed ND ICD, Primo ICD, Protecta ICD and CRT-D, Secura ICD, Virtuoso ICD, Virtuoso II ICD, Visia AF ICD, Viva CRT-D, the CareLink 2090 Programmer, the 2490C version of its CareLink Monitor and versions 24950 and 24952 of its MyCareLink Monitor.
Medical Advisory (ICSMA-19-080-01) can be read at: https://ics-cert.us-cert.gov/advisories/ICSMA-19-080-01
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 nationally-recognized test labs, so it doesn’t matter how or who did your testing outside of China, your devices must be retested by one of the Chinese NRTLs to applicable standards.
We are performing our testing at the Beijing Institute of Medical Devices (BIMT) – a World-Class testing laboratory equipped with the very latest test equipment (including beautiful, new 10m and 30m EMC chambers brought from France, and equipped with top-of-the-line equipment by Rohde&Schwarz, Tektronix, Agilent, etc.). Most importantly, I found their engineers to be very knowledgeable and kind. It was a really pleasant experience!
PS. My photos of Beijing are at: http://www.flickr.com/photos/prutchi/sets/72157640189751133/
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 manufacturers about device behavior and patient risks so that MR-conditional AIMDs can be designed and labeled appropriately. The introduction to the TIR explains:
Test methods described in this Technical Specification are primarily designed and intended as bench-top tests using equipment and techniques to simulate the fields (B0 static, gradient, and RF) found in MR 1.5 T scanners. Although, in a few cases, clinical scanner tests are implied, in all others, the AIMD manufacturer assumes the burden for development and validation of clinical scanner-based test methods. Furthermore, the test signals and parameters specifically described within this Technical Specification for bench-top testing are not being encouraged or recommended for use on clinical scanners and to do so might result in scanner damage.
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 talking about a conspiracy against Jack, who was supposed to spill the beans on how to hack a pacemaker at the Black Hat Briefings hacking conference in Las Vegas.
In my humble opinion however, there are much easier ways to kill someone than to figure out a target’s IPG model, reverse engineer the AIMD’s communications protocol, and then get close enough to the victim to trigger inappropriate therapy delivery.
Needless to say, the dramatization of such an exploit in the December 2012 “Homeland” episode about a terrorist hacking into the vice-president’s ICD, commanding it to induce VF was totally ridiculous. Unfortunately, the general public (and the “news” media) is so ignorant that it believes anything concocted by Hollywood, so it comes to no surprise that Barnaby’s pacemaker hack would cause such sensation.
In reality, if something sinister went on, I would say that criminal minds and powerful players would probably have a lot more interest in Barnaby Jack’s ways of “jackpotting”, or exploiting ATMs in order to make them dispense cash.
The cause of death hasn’t been announced, but no foul play is being suspected by the San Francisco Police Department.
It is obvious that Barnaby Jack was a talented person who was passionate about his work, and it’s unfortunate that the media would exploit his death to sell sensationalistic stories instead of respecting the grief of his loved ones and patiently wait for an official report from the city’s medical examiner’s office.
The implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be designed and constructed so that no irreversible change will be caused by exposure to microgravity conditions.
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”. Unlike other commercial devices, developing medical implantable devices takes place in a heavily regulated environment which requires decisive proof of the devices’ safety and efficacy. Costs, schedules, and clinical strategies must be planned accordingly to achieve a successful exit. This two-part lecture will focus on the practical technical and business-oriented aspects of planning and executing the development of implantable medical devices intended for a commercial application.
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 “Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software”
According to the guidance, “The need for effective cybersecurity to assure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information.”
Comments from the public are due to the FDA by September 12, 2013.
Click here for a pdf copy of the guidance document.
From: Microscopic magnetic stimulation of neural tissue, Giorgio Bonmassar, Seung Woo Lee, Daniel K. Freeman, Miloslav Polasek, Shelley I. Fried & John T. Gale, Nature Communications 3, Article number: 921
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 in a living organism. Dr. Gale’s research team has shown that placing a micro-magnet on the auditory pathway of hamsters triggers nerve signal transmission. Stimulation from uniquely designed magnetic fields could avoid unintentional activation of nearby brain areas and the associated side effects. Micro-magnets might one day provide stimulation for heart pacing, cochlear implants, Parkinson’s disease, or neural prosthetics.”
I have worked on TMS before, even home-brewed a TMS device (the design of which is detailed in my book “Design and Development of Medical Electronic Instrumentation: A Practical Perspective of the Design, Construction, and Test of Medical Devices”), but it takes a very large amount of energy to induce sufficient current in the tissue to stimulate excitable tissue, so it peaked my attention that to do so at the implantable level would be under consideration.
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 feet range to fire, or to rewrite their firmware.
This is the reason why MICS (“RF telemetry”) is under renewed scrutiny by regulators. Thoughts for mitigating this issue include requiring authentication and exchange of encryption keys via close-range (inductive) telemetry and other means before allowing any programming via MICS.
Click here for the original article. The text reads:
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.
Image Credit: Monash Vision Group, Monash University, Australia
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 the camera and converts it into signals enabling the brain to build up a visual construct; and cortical implants of several tiles which will be the portal for the stimulation of the visual cortex. Continue reading