Quadriplegia

BOSTON--( BUSINESS WIRE )--Mass General Brigham is establishing the Implantable Brain-Computer Interface Collaborative Community (iBCI-CC). This is the first Collaborative Community in the clinical neurosciences that has participation from the U.S. Food and Drug Administration (FDA). BCIs are devices that interface with the nervous system and use software to interpret neural activity. Commonly, they are designed for improved access to communication or other technologies for people with physical disability. Implantable BCIs are investigational devices that hold the promise of unlocking new frontiers in restorative neurotechnology, offering potential breakthroughs in neurorehabilitation and in restoring function for people living with neurologic disease or injury. The iBCI-CC ( https://www.ibci-cc.org/ ) is a groundbreaking initiative aimed at fostering collaboration among diverse stakeholders to accelerate the development, safety and accessibility of iBCI technologies. The iBCI-CC brings together researchers, clinicians, medical device manufacturers, patient advocacy groups and individuals with lived experience of neurological conditions. This collaborative effort aims to propel the field of iBCIs forward by employing harmonized approaches that drive continuous innovation and ensure equitable access to these transformative technologies. One of the first milestones for the iBCI-CC was to engage the participation of the FDA. “Brain-computer interfaces have the potential to restore lost function for patients suffering from a variety of neurological conditions. However, there are clinical, regulatory, coverage and payment questions that remain, which may impede patient access to this novel technology,” said David McMullen, M.D., Director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health (CDRH), and FDA member of the iBCI-CC. “The IBCI-CC will serve as an open venue to identify, discuss and develop approaches for overcoming these hurdles.” The iBCI-CC will hold regular meetings open both to its members and the public to ensure inclusivity and transparency. Mass General Brigham will serve as the convener of the iBCI-CC, providing administrative support and ensuring alignment with the community’s objectives. Over the past year, the iBCI-CC was organized by the interdisciplinary collaboration of leaders including Leigh Hochberg, MD, PhD, an internationally respected leader in BCI development and clinical testing and director of the Center for Neurotechnology and Neurorecovery at Massachusetts General Hospital; Jennifer French, MBA, executive director of the Neurotech Network and a Paralympic silver medalist; and Joe Lennerz, MD, PhD, a regulatory science expert and director of the Pathology Innovation Collaborative Community. These three organizers lead a distinguished group of Charter Signatories representing a diverse range of expertise and organizations. “As a neurointensive care physician, I know how many patients with neurologic disorders could benefit from these devices,” said Dr. Hochberg. “Increasing discoveries in academia and the launch of multiple iBCI and related neurotech companies means that the time is right to identify common goals and metrics so that iBCIs are not only safe and effective, but also have thoroughly considered the design and function preferences of the people who hope to use them.” Jennifer French said, “Bringing diverse perspectives together, including those with lived experience, is a critical component to help address complex issues facing this field.” French has decades of experience working in the neurotech and patient advocacy fields. Living with a spinal cord injury, she also uses an implanted neurotech device for daily functions. “This ecosystem of neuroscience is on the cusp to collectively move the field forward by addressing access to the latest groundbreaking technology, in an equitable and ethical way. We can’t wait to engage and recruit the broader BCI community.” Joe Lennerz, MD, PhD, emphasized, “Engaging in pre-competitive initiatives offers an often-overlooked avenue to drive meaningful progress. The collaboration of numerous thought leaders plays a pivotal role, with a crucial emphasis on regulatory engagement to unlock benefits for patients.” The iBCI-CC is supported by key stakeholders within the Mass General Brigham system. Merit Cudkowicz, MD, MSc, chair of the Neurology Department, director of the Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital, and Julianne Dorn Professor of Neurology at Harvard Medical School, said, “There is tremendous excitement in the ALS [amyotrophic lateral sclerosis, or Lou Gehrig’s disease] community for new devices that could ease and improve the ability of people with advanced ALS to communicate with their family, friends, and care partners. This important collaborative community will help to speed the development of a new class of neurologic devices to help our patients.” Professor Thomas Oxley, CEO & Founder of Synchron, stated, “It’s an honor to be part of this community, at such a pivotal moment, driving innovation in this nascent field of neuroprosthetics to potentially help so many people. It’s through a diverse group like this that we can engineer solutions with a patient-first ethos.” Bailey McGuire, program manager of strategy and operations at Mass General Brigham’s Data Science Office, said, “We are thrilled to convene the iBCI-CC at Mass General Brigham’s DSO. By providing an administrative infrastructure, we want to help the iBCI-CC advance regulatory science and accelerate the availability of iBCI solutions that incorporate novel hardware and software that can benefit individuals with neurological conditions. We’re excited to help in this incredible space. For more information about the iBCI-CC, please visit https://www.ibci-cc.org/ . About Mass General Brigham Mass General Brigham is an integrated academic health care system, uniting great minds to solve the hardest problems in medicine for our communities and the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a nonprofit organization committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation’s leading biomedical research organizations with several Harvard Medical School teaching hospitals. For more information, please visit massgeneralbrigham.org . About the iBCI-CC Organizers Leigh Hochberg, MD, PhD is a neurointensivist at Massachusetts General Hospital’s Department of Neurology, where he directs the MGH Center for Neurotechnology and Neurorecovery . He is also the IDE Sponsor-Investigator and Director of the BrainGate clinical trials, conducted by a consortium of scientists and clinicians at Brown, Emory, MGH, VA Providence, Stanford, and UC-Davis; the L. Herbert Ballou University Professor of Engineering and Professor of Brain Science at Brown University; Senior Lecturer on Neurology at Harvard Medical School; and Director, VA RR&D Center for Neurorestoration and Neurotechnology in Providence. Jennifer French, MBA, is the Executive Director of Neurotech Network , a nonprofit organization that focuses on education and advocacy of neurotechnologies. She serves on several Boards including the IEEE Neuroethics Initiative , Institute of Neuroethics , OpenMind platform, BRAIN Initiative Multi-Council and Neuroethics Working Groups, and the American Brain Coalition . She is the author of On My Feet Again (Neurotech Press, 2013) and is co-author of Bionic Pioneers (Neurotech Press, 2014). French lives with tetraplegia due to a spinal cord injury. She is an early user of an experimental implanted neural prosthesis for paralysis and is the Past-President and Founding member of the North American SCI Consortium . Joe Lennerz, MD PhD, serves as the Chief Scientific Officer at BostonGene , an AI analytics and genomics startup based in Boston. Dr. Lennerz obtained a PhD in neurosciences, specializing in electrophysiology. He works on biomarker development and migraine research. Additionally, he is the co-founder and leader of the Pathology Innovation Collaborative Community , a regulatory science initiative focusing on diagnostics and software as a medical device (SaMD), convened by the Medical Device Innovation Consortium . He also serves as the co-chair of the federal Clinical Laboratory Fee Schedule (CLFS) advisory panel to the Centers for Medicare & Medicaid Services (CMS).

Each of the participants in Neuralink's PRIME trail will have the N1 device implanted on their brain by the company’s R1 robot. Once in place, the implant’s 1,024 electrodes will record neurological activity and transmit the data to a connected app, where an algorithm will translate the brain activity into computer controls. Less than a month after Neuralink founder Elon Musk announced that the company’s brain-computer interface technology had been implanted in a human for the first time, that study participant is already taking the first steps toward controlling a computer using only their mind, according to Musk. His latest update on the Neuralink clinical trial came, once again, via X, the social media platform he owns. During a livestreamed Spaces event with journalist Katherine Brodsky on Monday night, according to Reuters, Musk reported that Neuralink’s technology has enabled the first implantee to control a computer cursor hands-free. “Progress is good, and the patient seems to have made a full recovery, with no ill effects that we are aware of,” he said. “Patient is able to move a mouse around the screen by just thinking.” Next up, the participant is being tasked with pushing the mouse’s buttons as many times as possible using only their thoughts, Musk said. The progress report arrived exactly three weeks after Musk’s last update on the long-awaited Neuralink trial. In a series of posts on X late last month, he announced that the company’s first human implant had been performed on Jan. 28 and that the patient was “recovering well.” The PRIME study—named after Neuralink’s precise robotically implanted brain-computer interface—was greenlit by the FDA last spring and began recruiting in the fall. At the time, the company said it was looking for volunteers aged 22 and older with quadriplegia caused by a cervical spinal cord injury or amyotrophic lateral sclerosis. Each of the participants will have Neuralink’s N1 device implanted on their brain by the company’s R1 robot. Once in place, the implant’s 1,024 electrodes will record neurological activity and transmit the data to a connected app, where an algorithm will translate the brain activity into computer controls. According to Neuralink, the primary study period will span 18 months, complete with periodic at-home and in-person clinical check-ins and regular brain-computer interface research sessions, followed by a five-year follow-up that will comprise another 20 clinic visits. The initial application for Neuralink’s technology—translating the neurological activity of individuals with paralysis into cursor movements and mouse clicks—has been dubbed Telepathy, Musk said in his late January update. In the future, in addition to linking anyone’s brain to their smartphone, Musk has claimed that Neuralink’s brain-computer interface could potentially be used to restore sight to the blind and mobility to the paralyzed. Despite the technology’s reported potential—or, perhaps, because of it—some scientists have expressed wariness over the company’s current trial. Researchers interviewed in the journal Nature this month took issue with the fact that the trial has not been registered at ClinicalTrials.gov, with no information available about its sites or protocol and most substantial updates on the study coming from either a single recruitment brochure or social media posts by Musk. “My assumption would be that the FDA and Neuralink are following the playbook to a certain extent,” Tim Denison, Ph.D., a neuroengineer at the University of Oxford, told Nature. “But we don’t have the protocol. So we don’t know that.”

精彩内容近日，NMPA官网显示，苏州特瑞药业的门冬氨酸钾注射液通过仿制药一致性评价，为国内首家过评。门冬氨酸钾注射液为电解质补充药，2022年在中国公立医疗机构终端销售额超过6亿元。作为电解质补充药，门冬氨酸钾注射液适用于各种原因引起的低钾血症，低钾血症引起的周期性四肢麻痹，洋地黄中毒引起的心律失常。米内网数据显示，门冬氨酸钾注射液在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端销售峰值为2019年超过8.7亿元，近年来该药市场持续萎缩，2020-2022年分别同比下滑15.71%、6.60%、12.17%，2022年销售额超过6亿元。中国公立医疗机构终端门冬氨酸钾注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局国内共有4家企业拥有门冬氨酸钾注射液生产批文，包括辽宁药联制药、内蒙古白医制药、苏州特瑞药业、华邦药业。苏州特瑞药业的门冬氨酸钾注射液率先通过一致性评价，为国内首家过评。苏州特瑞药业过评品种来源：米内网一致性评价进度数据库截至目前，苏州特瑞药业已有14个品种通过或视同通过一致性评价，其中盐酸尼洛替尼胶囊、门冬氨酸钾注射液为国内首家过评。资料来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦