paralysis News
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Aurobindo Pharma receives USFDA Approval for Potassium Chloride ER Tablets
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Potassium Chloride ExtendedRelease tablets, 8 mEq (600 mg) and 10 mEq (750 mg). Potassium Chloride Extended-Release tablets, a generic version of Upsher-Smith’s Klor-Con® Extended Release tablets. The product will be ...
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ClearPoint Neuro Congratulates Blackrock Neurotech on Receiving Breakthrough Device Designation from the FDA for the MoveAgain Brain-Computer Interface System
ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today congratulates partner Blackrock Neurotech for receiving Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its groundbreaking MoveAgain Brain Computer Interface (BCI) system. There are an estimated ...
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Synchron Announces Enrollment of First Patient in U.S. Endovascular Brain Computer Interface Study COMMAND in Patients With Severe Paralysis
Synchron and Mount Sinai Hospital in New York Advance Industry-First FDA-Approved Clinical Trial for Brain-Computer Interface in U.S. Paralysis is a devastating condition for more than 5 million patients in the United States Synchron, an endovascular brain-computer (BCI) interface company, today announced the enrollment of the first patient in the US clinical trial, COMMAND, for patients ...
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APrevent and hearLIFE Group signed the exclusive distribution agreement
APrevent announced on 17TH December that APrevent and hearLIFE signed the exclusive distribution agreement for APrevent® VOIS in Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam, Cambodia, Laos, Myanmar and Brunei. We are going to provide patients with glottic insufficiency/unilateral vocal fold paralysis an innovative, safe and effective surgical treatment. hearLIFE Group has a ...
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Synchron announces first direct-thought tweet, “Hello World,”using an implantable brain computer interface
Synchron, a brain computer interface company, today announced a Twitter takeover by Philip O’Keefe, one of the patients implanted with the Stentrode brain computer interface. Mr. O’Keefe is the first person to successfully message the world on social media directly through thought using an implantable brain computer interface. Mr. O’Keefe, a 62-year-old man with amyotrophic ...
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Neuraptive Therapeutics Announces FDA Clearance of a Second IND Application for NTX-001 in the Prevention of Postoperative Facial Paralysis and Plans to Initiate a Phase 2 Clinical Study Later This Year
NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves. Neuraptive plans to conduct a Phase 2 Multicenter, Randomized, Controlled Study Evaluating the Safety and Efficacy of NTX-001 versus Standard of Care in Treatment and Prevention of Facial Paralysis Requiring Surgical Repair. ...
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Synchron receives green light from FDA to begin breakthrough trial of implantable brain computer interface in US
Synchron, a venture-backed brain data transfer company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for its flagship product, the Stentrode™ motor neuroprosthesis. This early feasibility study (EFS) of the device will begin later this year at Mount Sinai Hospital, New York, and will assess the safety ...
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APrevent signed the distribution agreement in Lithuania
APrevent announced on 7TH December that APrevent and Labostera signed the distribution agreement for APrevent® VOIS in Lithuania. We are going to provide patients with glottic insufficiency/unilateral vocal fold paralysis an innovative, safe and effective surgical treatment. Labostera was founded in year 2005, they are experienced in ENT surgical products including surgical voice ...
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Synchron Announces First Human U.S. Brain-Computer Interface Implant
Synchron, an endovascular brain-computer interface (BCI) company, today announced the first human BCI implant in the United States. This procedure represents a significant technological milestone for scalable BCI devices and is the first to occur in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery. The procedure was performed at Mount Sinai West in ...
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Synchron Appoints Kurt Haggstrom as Chief Commercial Officer
Synchron, an endovascular brain-computer (BCI) interface company, today announced the appointment of Kurt Haggstrom as Chief Commercial Officer. Haggstrom brings an extensive background in medical device commercialization and product launches, with a technical background in R&D engineering, holding over 20 U.S. patents. “I am honored and excited to join the Synchron team and be part of ...
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Synchron Expands Advisory Board as Brain-Computer Interface Device Stentrode Advances into Patients in US Clinical Trials
Synchron, a brain computer interface (BCI) company, today announced the expansion of its advisory board comprised of industry pioneers, to provide strategic guidance in support of the Company’s clinical development plans, corporate strategy and growth. The members of the advisory board are visionaries across the technology, neuroscience and medical device industry, which include Edward ...
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Flat Medical announced FDA 510(k) clearance of EpiFaith, the Epidural Safety Solution
Flat Medical Co., Ltd., the medtech company specializing in clinical safety solutions, announced it received 510(k) clearance from the U.S. Food and Drug Administration for its EpiFaith® syringe to deliver safe epidural locating solution. Based on the LOR technique, the EpiFaith® syringe is a physician-centered safeguard for epidural analgesia, which is indicated for painless labor, ...
By Flat Medical
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Sofregen Receives 510(k) Clearance for Silk Voice - The First and Only Natural Silk Protein Injectable Product for Tissue Bulking
Sofregen Medical, Inc. (Sofregen), an early stage commercial biotechnology company developing products for medical aesthetics and reconstructive surgery, announced today that Silk Voice has been cleared by the U.S. Food and Drug Administration (FDA) for augmenting vocal fold tissue for phonation improvement. This is the first and only FDA cleared product made from solubilized silk protein and is ...
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Synchron Announces Long-Term Safety Results from Fully Implanted Endovascular Brain-Computer Interface Stentrode for Severe Paralysis
Four Patients With ALS Who Received Stentrode™ Implant Gained Ability to Perform Daily Online Tasks No Serious Adverse Events Reported after 12 Months Synchron, a brain computer interface (BCI) company, today announced the results from a study in which four people with ALS received an implant of Synchron’s Stentrode™ device, a small mesh-like material inserted ...
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Team Gleason Partners with Synchron to Redefine Accessibility
Team Gleason and Synchron, an endovascular brain computer interface company, today announced a partnership agreement to provide patient-focused feedback on their platform to transform daily life for patients with physical and speech disabilities like ALS, muscular dystrophy, and cerebral palsy. The partnership will enable Synchron to collaborate with Team Gleason’s expert committees and an ...
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MS Clinical Trial starting at East Kent
Rex Bionics is the pioneer of the REX® robotic rehabilitation device that provides standing, walking and exercise support for people with lower limb weakness or paralysis; and is used by people who have suffered a spinal cord injury, stroke, traumatic brain injury or other neurological condition such as multiple sclerosis. Rex Bionics has worked with physiotherapists to develop the ...
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CVS/pharmacy kicks off 9th annual ALS fundraising Campaign in stores nationwide
CVS/pharmacy has kicked-off its ninth annual in-store fundraising campaign to support the fight against amyotrophic lateral sclerosis (ALS). Since 2002, CVS/pharmacy has partnered with the ALS Therapy Alliance (ATA) to help advance ALS research. To date, CVS/pharmacy has raised more than $19 million in its stores--a single $1 donation at a time -- to support the funding of new clinical research ...
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ALS research gets a $4.1 million boost from CVS/pharmacy fundraising Campaign
In just 21 days, CVS/pharmacy's ninth annual in-store fundraising campaign to support the fight against amyotrophic lateral sclerosis (ALS) brought in $4.1 million. The funds raised by the campaign will be donated to the Boston-based ALS Therapy Alliance (ATA) to support the funding of new clinical research aimed at developing new therapies for ALS patients and focused on the ultimate goal of ...
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The Lancet: Nerve transfer surgery restores hand function and elbow extension in 13 young adults with complete paralysis
Nerve transfer surgery has enabled 13 young adults with complete paralysis to regain movement and function in their elbows and hands, according to the largest case series of this technique in people with tetraplegia (paralysis of both the upper and lower limbs), published in The Lancet. During the surgery, Australian surgeons attached functioning nerves above the spinal injury to paralysed ...
By Siemens AG
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Alume Biosciences Granted FDA Fast Track Designation of ALM-488 for Surgical Nerve Visualization
Alume Biosciences, Inc., a clinical stage biotechnology company developing nerve-targeted pharmaceuticals for surgical and therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead compound ALM-488. ALM-488 is an investigational fluorescently labelled nerve targeting pharmaceutical being developed as an adjunct for the ...
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