Neurotechnology, the use of medical electronics on the human nervous system, is offering new options for people living with neurological conditions, enhancing diagnoses and aiding in human performance. Let’s take a look at what made headlines over the month of September 2020. These headlines address technical advancements, changes in access and expanding applications of current technologies.
Technology and Access Developments
- Those living with obstructive sleep apnea have expanded access to a hypoglossal nerve stimulation device from Inspire Medical Systems. Humana recently announced they will cover the device.
- Theranica Bio-Electronics Ltd. gained CE Mark approval for their Nerivio device, a non-invasive, smartphone-controlled device for the treatment of migraine headaches.
- The Heydar Aliyev Foundation announced the launch of a program to support 90 surgeries for people with hearing impairments to receive cochlear implants.
- Gridpad Trilogy from Control Bionics was released. It is a communication tool for people living with high level paralysis from conditions like ALS or cerebral palsy that uses EMG control.
- Urinary and fecal incontinence sacral nerve neuromodulation device from Axonics Modulation Technologies, Inc. gains a recommendation from NICE in the UK.
- Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements was published in JAMA Otolaryngology–Head & Neck Surgery
- An efficacy study of a fully implanted neuroprosthesis for functional benefit to individuals with tetraplegia due to spinal cord injury has been funded by the CDMRP.
- U.S. Pain Foundation and Sunbeam team up for National Pain Awareness Month. This is another example of industry working together with patient advocacy groups to bring chronic pain to the forefront.
- Clinical study initiated to examine the ability of Myant’s Textile-Based Biometric Solutions to capture ECG and other biometrics in the Pediatric Population.
- A new research study from Wake Forest Baptist Health used closed-loop, acoustic stimulation (HIRREM) to treat insomnia. It was published in Brain and Behavior.
- B-Temia Inc. gained FDA clearance for their Keeogo Dermoskeleton targeted for stroke survivors with lower limb impairments or weakness.
- Expanded access for people living with upper limb paralysis. The Myomo, Inc. wearable robotic now has coverage under Medicare and Medicaid Services.
- Nexstim will begin a pilot study in Finland to test their new accelerated TMS protocol called iTBS. This first small study will target people living with severe depression.
- A new study conducted by Dr, Krishnan Chakravarthy from UC San Diego reveals that spinal cord stimulation helped with pain and motor symptoms for people living with Parkinson’s disease.
- A new research paper reveals that tactile rehabilitation paired with vagus nerve stimulation may aid in sensory recovery from a peripheral nerve injury. The study was published in the Journal Behavior Brain Research.
Business Arrangements & News
- Boehringer is looking to team up with Click Therapeutics, Inc. to develop a tool for schizophrenia. Here is their development pipeline.
- A roadmap into the future of neurostimulation approaches for bladder & bowel management for spinal cord injury was published in the Journal Spinal Cord.
- RxFunction, Inc. gained a DOD grant to further develop their sensory technology to improve balance among lower limb amputees.
- HealthTech Connex Inc. secures $2M in funding to expand their NeuroCatch platform to the U.S. This could help people living with brain injury or multiple sclerosis.
- Signifier Medical Technologies for closing their Series C investment round. Looking forward to further developments of their eXciteOSA for mild sleep apnea.
- Salvia Bioelectronics, a Dutch neurostimulation company targeting chronic migraines, has raised €26M from new and existing investors in a Series A funding round.
There are several FDA virtual Public Meetings:
- Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond: September 29
- Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation: September 30
- Medical Device User Fee Amendments for FYs 2023–2027: October 27
Awareness Month for Neurological Conditions
September is Pain Awareness Month. There are many neuromodulation options for various types of pain. Many alternatives can be found on the Pain Management directory from Neurotech Network. https://neurotechnetwork.org/directory-home/pain-management/
September is also Deaf Awareness Month. While we respect the deaf culture and community, neurotech has a key role for people who may benefit from a cochlear implant. Here is our directory of devices: https://neurotechnetwork.org/directory-home/deaf-hard-of-hearing/
Spinal Cord Injury Awareness month is also in September. There are an array of neurotech devices to regain function, act as an assistive device or boost the rehabilitation process. Here is the link to find our commentary on this topic and the device directory: https://neurotechnetwork.org/directory-home/spinal-cord-injury/