Showing all posts written by Noorean Gill
Noorean received her B.S. in Mechanical Engineering from USC and her J.D. from UC Irvine School of Law. During law school, Noorean served as Vice President of the Intellectual Property and Cyberlaw Society and worked in the Intellectual Property, Arts, and technology Clinic. She also received Dean's Awards in Trademark Law and patent Office Practice.
Noorean worked as a summer associate at the firm in 2016 and joined the firm as an associate in 2017.
Medtronic recently announced that the U.S. Food and Drug Administration (FDA) has approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application. Medtronic’s DBS Clinician Programmer is presently being launched in Europe and is expected to be launched in the United States before the end of July 2018.
DBS therapy involves the delivery of electrical stimulation to specific areas of the brain using a surgically-implanted device. About 125,000 Medtronic Activa devices are implanted globally. Medtronic’s Activa DBS system is used as therapy for neurological diseases including Dystonia and Parkinson’s disease.
The Activa Programming Application is designed for use with the Samsung Galaxy Tab S2 tablet. According to Medtronic’s press release, the purpose of the application is to “enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients.” The programmer is expected to have an immediate impact on thousands of patients’ post-implant care. For example, the programmer will allow the service life of certain Activa rechargeable implantable neurostimulators to be extended by 6 years, giving patients about 15 years between device replacement surgeries.
Dr. Mohammad Maarouf, associate professor, head of the Department of Stereotaxy and Functional Neurosurgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Germany stated that the programmer’s “intuitive, visual interface and task-based workflow makes daily use easier, saving [him] time to focus on what’s most important-[his] patients.”
According to Medtronic’s press release, Medtronic’s DBS Clinician Programmer is also approved for use with the Activa DBS systems for treating refractory epilepsy, which will be launched in the United States later this year.
U.S. to Have its Own Supply of the Most Commonly Used Medical Imaging Isotope for the First Time in 30 Years
Medical imaging isotopes are used to diagnose various diseases, such as cancer and coronary artery disease, and to evaluate brain, lung, kidney, and liver function. According to an U.S. Food and Drug Administration (FDA) press release, the most widely used medical imaging isotope, Technetium-99m (Tc-99m), is used in over 80% of the United States’ nuclear medical imaging procedures. Used in conjunction with certain diagnostic scanner devices, Tc-99m transmits signals which are used to generate images of organs. This information assists medical professionals in detecting medical issues and making decisions related to diagnosis and treatment.
According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, “[e]very day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m.” However, according to the FDA press release, for thirty years, the U.S. has relied on other countries for its supply of Molybdenum-99 (Mo-99), the source of Tc-99m. As part of that process, the U.S. has been exporting highly enriched uranium. As a result of the complex supply chain, the U.S. has encountered challenges such as high costs and shortages of the isotope. Supply chain issues have also caused many medical professionals to opt to use different isotopes, which can mean higher doses of radiation or even higher costs.
To try to remedy some of these issues, Congress enacted the American Medical Isotopes Production Act in 2012. According to the FDA press release, the act required evaluation of and support for projects related to the domestic production of Mo-99 for medical purposes, without the use of highly enriched uranium.
The FDA press release notes that the U.S. Food and Drug Administration (FDA) has now approved NorthStar Medical Radioisotopes’ RadioGenix System, which is the first system for producing Tc-99m that uses non-uranium based Mo-99. According to Dr. Woodcock, the FDA’s approval of this system “will help to ensure more reliable, clean and secure access to this important imaging agent…”
According to a statement by FDA Commissioner Scott Gottlieb, M.D.,
while we needed to preserve the availability of Tc-99m for its important medical purpose, it was critical that we find a more stable, secure and sustainable technology for production.
Moving forward, according to the FDA announcement, the Nuclear Regulatory Commission is “issuing guidance that will advise medical and commercial nuclear pharmacy users on the license amendments they will need to possess and use the RadioGenix System.”