FDA Approves New Zika Assay
The FDA issued an emergency use authorization for a PCR assay for detection and differentiation of RNA from Zika virus, dengue virus, chikungunya virus, and West Nile virus in serum, and for the detection of Zika virus RNA in urine.
The CII-ArboViroPlex rRT-PCR assay was developed by Columbia University’s Center for Infection and Immunity.
The assay is intended for use with specimens collected from individuals with clinical signs and symptoms associated with Zika virus infection or a history of residence in or travel to a region with active Zika transmission at the time of travel, or other epidemiological criteria.
Camber Spine Technologies Wins FDA Clearance for Spinal Implant
Camber Spine Technologies received 510(k) clearance from the FDA to market its SPIRA Open Matrix ALIF spinal implant devices.
The implants are indicated for use in skeletally mature patients with degenerative disc disease. The 3D-printed devices increase fusion rates and spinal stabilization.
The series, including five SPIRA spinal interbody cages for cervical, lateral, and posterior lumbar spine, will be released in the U.S. in the coming months.
Glytec Receives 510(k) Approval for Diabetes Management Software
Glytec announced its fourth FDA 510(k) clearance, adding additional capabilities to its Glucommander diabetes management system.
The latest approval encompasses a titration module for inpatients undergoing enteral nutrition, an insulin-to-carb ratio titration option for outpatients, more flexible messaging for dose adjustments, and improved workflow capabilities.
The company claims the platform delivers safety improvements and annual savings as high as $20,000 per licensed acute care bed.
Apple Wins Patent for Electronic Health Data Monitor
Apple secured a patent for an electronic health data device, indicating the company’s continued interest in medical devices.
The device computes health data using sensors and electronic interfacing with the user’s body parts. It uses a camera, a proximity sensor, an ambient light sensor and a processing unit to track measures ranging from blood pressure index and pulse rate to oxygen saturation.
The patent award follows reports that the company has plans for a noninvasive blood sugar monitor. It is collaborating with glucose monitoring company Dexcom to integrate glucose sensors with Apple watches.
FDA Clears Renovis’ Fifth Titanium Structure Implant System
Renovis Surgical has secured FDA 510(k) clearance for its 3D-printed titanium interbody fusion systems.
The system includes direct posterior or transforaminal implants of multiple widths, heights and lengths. Renovis previously received FDA clearance for four other porous titanium structure product groups.
The technology allows bones to attach to implant surfaces and have the potential for biologic fixation deep into the pore structure.
iCubate Blood Infection Assay Gets FDA Clearance
The FDA cleared iCubate’s iC-System and blood infection assay for marketing.
The iC-System is the firm’s first approved assay, based on technology developed by the company to detect several pathogens at once and identify potentially pathogenic bacteria or resistance markers.
The system and assay provide test results as much as 48 hours earlier than conventional tests, the company said.