Paralysis

ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System

Retrieved on: 
Monday, March 11, 2024

This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.

Key Points: 
  • This acceptance follows ONWARD Medical’s announcement last week that its investigational ARC-BCI System was awarded FDA Breakthrough Device Designation (BDD), a requirement for TAP consideration.
  • ONWARD Medical is only the second BCI company to be accepted into the program.
  • TAP provides ONWARD Medical with early and frequent strategic engagement from the FDA, patients, providers, and payers to facilitate more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance.
  • “We are honored to be one of the first BCI companies included in this important program, which allows for the fastest FDA review times of new medical technology,” said ONWARD Medical CEO Dave Marver.

ONWARD® Medical Awarded 10th Breakthrough Device Designation for Brain-Computer Interface (BCI) from US FDA

Retrieved on: 
Thursday, February 29, 2024

This is the tenth FDA BDD awarded to ONWARD Medical.

Key Points: 
  • This is the tenth FDA BDD awarded to ONWARD Medical.
  • The designation is reserved for novel, cutting-edge therapies addressing an unmet need and provides many potential regulatory and reimbursement advantages.
  • This latest award gives ONWARD Medical priority FDA review, the opportunity to interact with FDA experts throughout the pre-market regulatory review phase, and the potential to seek additional reimbursement for its ARC-BCI System.
  • “Brain-computer interface technology unlocks the transformative potential to enhance ARC-IM with thought-driven control of movement after paralysis,” said ONWARD Medical CEO Dave Marver.

Herbal medicinal product: Lini semenArray, C: ongoing call for scientific data

Retrieved on: 
Tuesday, March 12, 2024

Herbal medicinal product: Lini semenArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Lini semenArray, C: ongoing call for scientific data

CMS Posts Final Medicare DMEPOS Fee Schedule Rate for the MyoPro®

Retrieved on: 
Friday, March 1, 2024

The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67.

Key Points: 
  • The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67.
  • On January 1, 2024, the MyoPro was officially classified in the brace benefit category, which enables reimbursement on a lump sum basis.
  • “This is an important milestone for qualified Medicare Part B beneficiaries with long-term muscular weakness or partial paralysis, and for Myomo as a company.
  • We extend thanks to the personnel at CMS for their efforts and for appreciating the benefits that powered braces such as the MyoPro can provide to Medicare Part B beneficiaries. "

Destroy Duchenne selects DNA Nanobots as Partner to Develop Non-Viral Gene Delivery Solution for Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, February 29, 2024

Duchenne Muscular Dystrophy (DMD) is a serious progressive, fatal genetic muscle wasting disease that impacts 1 in 3,500 almost exclusively boys and over 300,000 worldwide.

Key Points: 
  • Duchenne Muscular Dystrophy (DMD) is a serious progressive, fatal genetic muscle wasting disease that impacts 1 in 3,500 almost exclusively boys and over 300,000 worldwide.
  • Current treatment options for DMD include steroid medications to maintain muscle strength, physical and occupational therapy, surgery, and viral gene therapy.
  • Elijah works with several biopharmaceutical companies and was intrigued by the targeted, non-viral full length dystrophin gene delivery approach of DNA Nanobots presented to him by DNA Nanobots Co-Founder and Chief Science Officer, Dr. Christopher Lucas.
  • “I am extremely encouraged by the promising targeted non-viral gene delivery approach that DNA Nanobots uses.

THE CHRISTOPHER & DANA REEVE FOUNDATION ANNOUNCES $3.1M SPINAL CORD INJURY RESEARCH GRANTS

Retrieved on: 
Wednesday, March 6, 2024

SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation, a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million. The grants support clinical trials and research tools aimed at accelerating the therapeutic development of SCI treatments.

Key Points: 
  • SHORT HILLS, N.J., March 6, 2024 /PRNewswire/ -- The Christopher & Dana Reeve Foundation , a leading nonprofit organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis, announced today three new spinal cord injury (SCI) research grants totaling $3.1 million.
  • The Reeve Foundation is dedicated to developing real-world treatments for people living with spinal cord injury (SCI) and paralysis.
  • Today, as 21st-century technology and cumulative scientific gains converge, we are on the cusp of a new era in spinal cord injury research.
  • "These grants represent a fresh approach to spurring the SCI scientific arena forward through our support of high-risk-high-reward endeavors that address unmet needs of individuals living with spinal cord injury," said Marco Baptista, Ph.D., Chief Scientific Officer of the Reeve Foundation.

LETTER: Biden Administration Must Accelerate Efforts to Free Kara-Murza

Retrieved on: 
Thursday, February 22, 2024

We the undersigned write to express a two-fold request of your administration.

Key Points: 
  • We the undersigned write to express a two-fold request of your administration.
  • Kara-Murza is an extremely vulnerable prisoner, and we fear that he may be the Kremlin's next victim if the United States does not act swiftly.
  • He is also currently being held as a political prisoner by Russian authorities.
  • We urge the Biden administration to act swiftly to bring Kara-Murza home and to increase efforts to seek the release of all Russian political prisoners.

Stalwart Law Group Lead Attorney Secures $28.7 Million Verdict for Paralyzed Los Angeles County Man in Medical Malpractice Case

Retrieved on: 
Thursday, February 15, 2024

LOS ANGELES, Feb. 15, 2024 /PRNewswire/ -- A Los Angeles jury awarded $28,724,350.29 in damages last week to a man who was left brain injured and paralyzed from a medical error during what should have been a routine procedure at Los Angeles Community Hospital.

Key Points: 
  • LOS ANGELES, Feb. 15, 2024 /PRNewswire/ -- A Los Angeles jury awarded $28,724,350.29 in damages last week to a man who was left brain injured and paralyzed from a medical error during what should have been a routine procedure at Los Angeles Community Hospital.
  • Mr. Leon sought medical attention at Los Angeles Community Hospital's emergency department on April 24, 2018, after swallowing a fishbone.
  • Despite recognizing the risks of her inability to intubate and oxygenate Mr. Leon, Dr.
  • The legal team representing Mr. Leon included Sean O'Neill, a partner at Stalwart Law Group , and William Collins, a partner at the Law Office of Marshall Silberberg.

Several companies are testing brain implants – why is there so much attention swirling around Neuralink? Two professors unpack the ethical issues

Retrieved on: 
Wednesday, February 14, 2024

Academic and commercial groups are testing “brain-computer interface” devices to enable people with disabilities to function more independently.

Key Points: 
  • Academic and commercial groups are testing “brain-computer interface” devices to enable people with disabilities to function more independently.
  • In January 2024, Musk announced that Neuralink implanted its first chip in a human subject’s brain.

How does a brain chip work?

  • Subjects in the company’s PRIME study – short for Precise Robotically Implanted Brain-Computer Interface – undergo surgery to place the device in a part of the brain that controls movement.
  • The chip records and processes the brain’s electrical activity, then transmits this data to an external device, such as a phone or computer.

A few companies are testing BCIs. What’s different about Neuralink?


Noninvasive devices positioned on the outside of a person’s head have been used in clinical trials for a long time, but they have not received approval from the Food and Drug Administration for commercial development.
There are other brain-computer devices, like Neuralink’s, that are fully implanted and wireless. However, the N1 implant combines more technologies in a single device: It can target individual neurons, record from thousands of sites in the brain and recharge its small battery wirelessly. These are important advances that could produce better outcomes.

Why is Neuralink drawing criticism?

  • Musk announced the company’s first human trial on his social media platform, X – formerly Twitter – in January 2024.
  • Neuralink did not register at ClinicalTrials.gov, as is customary, and required by some academic journals.
  • Neuralink, on the other hand, embodies a private equity model, which is becoming more common in science.
  • However, the secretary did note an “adverse surgical event” in 2019 that Neuralink had self-reported.
  • In a separate incident also reported by Reuters, the Department of Transportation fined Neuralink for violating rules about transporting hazardous materials, including a flammable liquid.

What other ethical issues does Neuralink’s trial raise?

  • In particular, it helps people recover a sense of their own agency or autonomy – one of the key tenets of medical ethics.
  • With BCIs, scientists and ethicists are particularly concerned about the potential for identity theft, password hacking and blackmail.
  • Given how the devices access users’ thoughts, there is also the possibility that their autonomy could be manipulated by third parties.

What’s next?

  • Musk has said his ultimate goal for BCIs, however, is to help humanity – including healthy people – “keep pace” with artificial intelligence.
  • Some types of supercharged brain-computer synthesis could exacerbate social inequalities if only wealthy citizens have access to enhancements.
  • For patients whose access to a device is tied to a research study, the prospect of losing access after the study ends can be devastating.


The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

Get Back UP Today Co-Captain Jamie Whitmore Inducted into Sacramento Sports Hall of Fame

Retrieved on: 
Thursday, February 8, 2024

ROCKAWAY, N.J., Feb. 8, 2024 /PRNewswire/ -- Get Back UP Today , the global movement empowering individuals facing mobility challenges, proudly announces the induction of TeamUP Co-Captain, Jamie Whitmore, into the prestigious Sacramento Sports Hall of Fame.

Key Points: 
  • ROCKAWAY, N.J., Feb. 8, 2024 /PRNewswire/ -- Get Back UP Today , the global movement empowering individuals facing mobility challenges, proudly announces the induction of TeamUP Co-Captain, Jamie Whitmore, into the prestigious Sacramento Sports Hall of Fame.
  • Jamie Whitmore becomes the first Paralympic athlete to be inducted into the Sacramento Sports HOF.
  • As a Co-Captain for Get Back UP Today, Jamie proudly wears an Allard AFO brace for both walking and cycling.
  • Join us in celebrating Jamie Whitmore's induction into the Sacramento Sports Hall of Fame, recognizing her indomitable spirit and inspiring journey.