NEWS Federal Communications Commission 445 12th Street, S.W. Washington, D. C. 20554 This is an unofficial announcement of Commission action. Release of the full text of a Commission order constitutes official action. See MCI v. FCC. 515 F 2d 385 (D.C. Circ 1974). News Media Information 202 / 418-0500 Internet: http://www.fcc.gov TTY: 1-888-835-5322 FOR IMMEDIATE RELEASE: NEWS MEDIA CONTACT: March 20, 2009 Bruce Romano: 202-418-2124 FCC ADOPTS RULES FOR NEW ADVANCED MEDICAL TECHNOLOGIES (ET Docket No. 06-135) Washington, D.C. – The Federal Communications Commission (FCC) today approved new rules to provide additional spectrum for wireless medical devices. Current rules accommodate wireless implanted medical devices for a variety of diagnostic and therapeutic functions, such as implantable cardiac pacemakers and defibrillators that can be adjusted wirelessly. Significant advances in both implanted and body-worn wireless medical technologies are increasing the demand for spectrum and for greater flexibility in how such devices operate and coexist. These new medical technologies will improve the diagnosis and treatment of a wide variety of medical conditions and, most importantly, improve quality of life for people coping with such conditions. Implanted and body-worn medical devices that rely upon wireless technologies have been introduced recently under waivers of the rules for applications such as blood glucose monitors, which support more timely and effective treatment for patients with diabetes. With the addition of new spectrum and adoption of rules for alternative operating parameters, newer generations of devices could be deployed that perform a greater variety of functions, such as implanted vagus nerve stimulators that send electric pulses to the brain to treat severe chronic depression and deep brain stimulators used to treat tremors related to Parkinson's disease. Such advances have the potential to significantly improve the quality of life and sophistication of therapy for countless Americans living with a variety of medical conditions and, in turn, could result in lower medical costs and extend the time between hospital visits and surgical procedures. The Commission’s action replaces the existing Medical Implant Communications Service (MICS) with a new Medical Device Radiocommunication Service (MedRadio). The MedRadio service remains under Part 95 of the Commission’s rules and maintains most of the technical rules of the MICS service in the spectrum previously allocated for MICS (402-405 MHz), but adds additional adjacent spectrum (401-402 MHz and 405-406 MHz) and provides greater operational flexibility to accommodate new types of devices, including body-worn devices and devices with simpler operating protocols, in the added spectrum. The rules are generally harmonized with standards in Europe and other regions of the world, providing important economies of scale to make these technologies more affordable, and providing a high level of assurance that travelers with such devices will be accommodate in most parts of the world. 2 Action by the Commission, March 19, 2009 by Report and Order (FCC 09-23). Acting Chairman Copps, Commissioners Adelstein and McDowell. Separate statements issued by Acting Chairman Copps, Commissioners Adelstein and McDowell. For additional information, contact Gary Thayer at (202) 418-2290 or gary.thayer@fcc.gov. ET Docket No. 06-135. – FCC – News and other information about the FCC is available at www.fcc.gov 3 STATEMENT OF ACTING CHAIRMAN MICHAEL J. COPPS RE: Investigation of the Spectrum Requirements for Advanced Medical Technologies, ET Docket No. 06-135; Amendment of Parts 2 and 95 of the Commission’s Rules to Establish the Medical Device Radiocommunication Service at 401-402 and 405-406 MHz, RM-11271; DexCom, Inc., Request for Waiver of the Frequency Monitoring Requirements of the Medical Implant Communications Service Rules, ET Docket No. 05-213; Biotronik, Inc., Request for Waiver of the Frequency Monitoring Requirements of the Medical Implant Communications Service Rules, ET Docket No. 03-92 Few uses of our spectrum could be more important than supporting new medical technologies that can extend and improve lives. Our nation’s medical researchers continue to develop extraordinary body-worn and implanted devices that are used to treat a variety of health conditions with less invasive patient treatment options. Today’s order takes us another major step forward with the establishment of a new Medical Device Radiocommunication Service, which incorporates the existing Medical Implant Communications Service band with additional spectrum for advanced wireless medical radiocommunication devices used for diagnostic and therapeutic purposes. Among other things, these devices are used to control heart rhythms to prevent attacks, mitigate the tremors of neurological patients, and control the delivery of insulin to patients with diabetes. I am always pleased to support these kinds of achievements. Once again I thank our Office of Engineering and Technology, working in conjunction with the National Telecommunications and Information Administration (NTIA), for developing these new rules. 4 STATEMENT OF COMMISSIONER JONATHAN S. ADELSTEIN RE: Investigation of the Spectrum Requirements for Advanced Medical Technologies, ET Docket No. 06-135; Amendment of Parts 2 and 95 of the Commission’s Rules to Establish the Medical Device Radiocommunication Service at 401-402 and 405-406 MHz, RM-11271; DexCom, Inc., Request for Waiver of the Frequency Monitoring Requirements of the Medical Implant Communications Service Rules, ET Docket No. 05-213; Biotronik, Inc., Request for Waiver of the Frequency Monitoring Requirements of the Medical Implant Communications Service Rules, ET Docket No. 03-92 With the approval of the new Medical Device Radiocommunication Service, the Commission is helping to facilitate exciting new medical technologies that will improve our lives. The addition of two megahertz of spectrum to the Medical Implant Communications Service band will be used for advance diagnostic, monitoring, and therapeutic wireless radiocommunication devices that can help doctors better treat their patients and benefit the health and comfort of so many. I hope that the order will spark more research and new medical applications so that we may continue to make strides in health care. For these reasons, I am pleased to support this order. I thank the National Telecommunication and Information Administration and our Office of Engineering and Technology for their work in crafting these rules. 5 STATEMENT OF COMMISSIONER ROBERT M. McDOWELL RE: Investigation of the Spectrum Requirements for Advanced Medical Technologies, ET Docket No. 06-135; Amendment of Parts 2 and 95 of the Commission’s Rules to Establish the Medical Device Radiocommunication Service at 401-402 and 405-406 MHz, RM-11271; DexCom, Inc., Request for Waiver of the Frequency Monitoring Requirements of the Medical Implant Communications Service Rules, ET Docket No. 05-213; Biotronik, Inc., Request for Waiver of the Frequency Monitoring Requirements of the Medical Implant Communications Service Rules, ET Docket No. 03-92 It is with great pleasure that I vote to approve this order, which establishes a new Medical Device Radio Communications Service and provides five megahertz of contiguous spectrum to power advanced diagnostic and therapeutic wireless devices. Our action today provides direct help to millions of people suffering from a variety of medical conditions such as diabetes, Parkinson’s disease, depression and cardiac ailments, to name a few. I am excited about the notices of proposed rulemaking that will result from our decision in this proceeding. The Alfred Mann Foundation has undertaken pioneering research that harnesses wireless technology to provide medical treatment and therapy to patients suffering from paralysis. In addition, GE Medical Systems is developing advanced body sensing technologies that would allow continuous patient monitoring whether the patient is located within or outside of a hospital setting. Similarly worthwhile is the proposal submitted by ON Semiconductor, which has the potential to deliver new and innovative services to the hearing impaired community. I am pleased that we will consider moving forward to develop a record through a notice of proposed rulemaking to more fully analyze the relevant issues. Many thanks to our team in the Office of Engineering and Technology, and our colleagues at the National Telecommunications and Information Administration, for your dedication and diligence. I look forward to learning about future scientific breakthroughs that result from your work, that of the private sector, as well as the important action taken by the Commission today.