FDA Updates – September 2023

Published by Daniel at September 1, 2023

Roo from Spark Biomedical is a neurostimulation device that reduces opioid withdrawal symptoms in infants...

Neurostimulation Device made to alleviate withdrawal symptoms in infants born addicted to opioids.

Opioid use during pregnancy can cause withdrawal syndrome in newborns, leading to symptoms like irritability, feeding difficulty, seizures, and respiratory issues. Infants are often admitted to the NICU for two to four weeks to alleviate these symptoms. However, the Roo device from Spark Biomedical is being tested for FDA approval to shorten the weaning process to ten days or less.

The device works through transcutaneous auricular neurostimulation (tAN) to stimulate the brain to discharge endorphins that reduce the need for morphine, which can have dangerous side effects during a critical neurodevelopment period. The Medical University of South Carolina has successfully used tAN therapy to manage opioid-dependent newborns and wean them off morphine in less than ten days.

TULA System for Awake Ear Tube Placement Receives FDA Approved

Ear infections are common in childhood and are typically treated with antibiotics. However, recurring infections can cause middle ear effusions, leading to hearing problems and inattentiveness. Treatment involves an incision in the eardrum and placing tympanostomy tubes to drain the liquid. Pain is a limiting factor, and general anesthesia is required, which comes with potential side effects and high costs.

Tusker Medical has received FDA approval for the TULA system, which uses an ionized anesthetic agent called TYMBION to place an ear tube without pain for patients six months and older. The TULA tube delivery system creates a hole in the tympanic membrane and positions the ear tube. This procedure offers an alternative to general anesthesia and allows patients to return to regular activity immediately.

Orthofix Physio-Stim with smartphone App cleared in the USA and Europe

Orthofix, a Texas-based company, has obtained FDA clearance for its newest Physio-Stim AI bone growth stimulators. The device offers a non-invasive option for treating challenging fractures by delivering pulsed electromagnetic fields to repair arm and leg non-union fractures.

The tool is lightweight, flexible, and portable, allowing freedom of movement. It stimulates bone growth by creating an electric field at the fracture site. The new version connects to the STIM Ontrack app for iOS devices, providing patients with reminders and guidance and allowing physicians to track prescription adherence.