Alcyone Therapeutics announced today that the FDA approved continued enrollment in a study of its ThecaFlex DRx drug delivery system. The company can continue enrolling in the PIERRE FDA investigational device exemption study for the implantable medical device. It evaluates the system, comprised of a subcutaneous port and intrathecal catheter system. This system provides chronic […]
Orthopedics
Glucotrack expands CGM tech to spinal epidural space
Glucotrack (Nasdaq:GCTK) announced today that it plans to expand its glucose monitoring technology to measure glucose in the epidural space. Rutherford, New Jersey-based Glucotrack said CGM taking readings in the spinal epidural space could integrate with existing treatments for painful diabetic neuropathy (PDN). Specifically, Glucotrack sees spinal cord stimulation (SCS) technology as a potential integration […]
Evonik invests in Allay Therapeutics to reduce need for opioids
Evonik announced today that it invested in Allay Therapeutics and its implant for treating pain after knee surgery. Inserted directly into the knee, the Allay implant may relieve pain for up to three weeks, according to a news release. Previous solutions worked for a maximum of three days, the company said. The technology helps promote […]
Early study supports experimental hydrogel injection for chronic low back pain
A study demonstrated that an experimental hydrogel formulation was safe and effective in substantially relieving chronic low back pain. Research presented at the Society of Interventional Radiology Annual Scientific Meeting in Boston supported the hydrogel, which was injected into spinal discs in an effort to relieve chronic low back pain caused by degenerative disc disease […]
Ariste Medical co-founder sees great potential for drug-coated implants and orthopedics
It’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession. In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations. More recently, her pre-commercial medtech development startup, Ariste Medical, won FDA 510(k) approval for […]
Locate Bio lands FDA breakthrough nod for bone infection device
Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
OsteoRemedies wins FDA nod for Remedy Spectrum GV hip spacer and bone cement
OsteoRemedies recently announced that it has received FDA clearance for its Remedy Spectrum GV hip spacer system and Spectrum GV bone cement. The system is designed to give surgeons a broad spectrum of treatment options with both Gentamicin and Vancomycin. “We are very proud to have the first FDA cleared dual-antibiotic spacer system and bone […]
Flexion reports data from Phase II bilateral osteoarthritis trial
Flexion Therapeutics (NSDQ:FLXN) touted data today from a Phase II trial assessing the bilateral dosing of its extended-release triamcinolone acetonide injection in people with bilateral osteoarthritis. The study found that bilateral injections of Flexion’s Zilretta therapy resulted in lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs). The company also […]
Genentech wins FDA nod for subcutaneous formulation of arthritis drug
Roche‘s (OTC:RHHBY) Genentech reported this week that the FDA approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients two years and older. The U.S. agency approved the intravenous formulation of Actemra for the same indication in 2011. Systemic juvenile idiopathic arthritis affects roughly 30,000 children in the U.S., according […]
Medtech stories we missed this week: August 3, 2018
From Esaote launching its new ultrasound device to Nipro’s Infraredx launching in Japan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Esaote launches new ultrasound devices Esaote announced in an Aug. 2 press release that it has launched its new MyLab X7, MyLab X6 and MyLab X5 ultrasound systems. […]
