Israeli device maker InSightec won FDA approval for its ExAblate MRI-guided focused ultrasound therapy with indication to treat pain resulting from bone metastases in patients who failed or aren’t good candidates for radiation therapy.
Bone metastases occur when cancer cells break off from the primary tumor site and spread to other parts of the body, commonly leaving patients with significant physical and emotional pain, according to a press release.
By Tom Ulrich
A cut, a bruise, a scrape…these can all cause pain that, while unpleasant, usually passes quickly. But for an estimated 3.75 million children and adults in the United States with neuropathic pain, the pain is debilitating and never goes away.
Rehab and physical therapy devices startup Hollywog landed a pair of FDA nods for its wireless back pain therapy devices, the WiTouch and the WiTouch Pro.
The devices use transcutaneous electrical nerve stimulation, a process in which electrical signals are transmitted through the skin to stimulate nerve or muscle fibers, to suppress pain signals before they they reach the brain and ramp up the body’s production of pain-relieving endorphins, according to the company’s website.
Neuros recently received an investigational device exemption from the FDA to evaluate its chronic pain management system, the electrical nerve block, for use in amputee patients to manage pain in the residual limb.
The memo detailed adverse events possibly associated with improper use of its Granuflo dialysis concentrate, including a possible 5-fold increase in heart-attack risk associated with the compound.