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 […]
Alcyone Lifesciences
Alcyone wins breakthrough device status for delivery device
Alcyone Lifesciences said today that its ThecaFlex DRx system won breakthrough device status from the FDA. The Lowell, Mass.-based company’s system features an implantable subcutaneous port and intrathecal catheter used to provide access for cerebrospinal fluid aspiration and infusion of therapies. “The breakthrough device designation for the ThecaFlex DRx System is an important milestone in […]
Medtech stories we missed this week: Oct. 27, 2017
From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows […]
