FDA approval for neurostimulation device to treat diabetic neuropathic pain
DyAnsys has received FDA approval for its First Relief device, a wearable tool which monitors pulses of a low-level electrical current over several days, made for diabetic peripheral neuropathy pain. The device is intended for multiple treatments for up to 56 days.
First Relief is a percutaneous electrical neurostimulation (PENS) device, intended for multiple treatments for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
“We are excited to have the FDA clearance of First Relief so that this device, which has been proven effective, can now be used to treat patients who have been experiencing pain related to diabetic neuropathy,” said DyAnsys CEO Srini Nageshwar.
The approval was based on a study testing First Relief against a placebo, and another device previously cleared by the FDA, and was conducted in the Jeevak Multispeciality Hospital in Warangal, India. This hospital is renowned for the treatment of diabetes.
Neuropathic pain is caused by damage or injury to the nerves whichtransfer information between the brain and spinal cord from the skin, muscles, and other parts of the body.
FDA approves new treatment for rare tumour
The FDA has approved crizotinib for adult and paediatric patients aged one year and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumours (IMT).
IMT appears in organs such as the lungs, stomach, bladder, or liver. These tumours are not cancerous, and do not usually spread. However, local growth within organs can cause problems for patients.
The drug is already approved to treat metastatic non-small cell lung cancer (NSCLC) in patients whose tumours are positive for ALK or ROS1 mutations, alongside for ALK-positive anaplastic large cell lymphoma in children and young adults. Crizotinib, marketed as Xalkori, was first introduced over a decade ago. The recommended dose for adults in 250mg orally twice daily, until disease progression or unacceptable toxicity.