FDA Issues Emergency Use Authorizations for Zika Testing Devices
The FDA issued two Emergency Use Authorizations for Zika virus in vitro diagnostic tests.
The EUAs follow a Health and Human Services determination last February that there is significant potential for a public health emergency involving the virus. The authorization applies to the TaqPath Zika Virus Kit, distributed by Thermo Fisher, and Columbia University’s CII-ArboViroPlex assay.
Abbott Wins FDA Marketing Nod for Smartphone-Compatible Cardiac Monitor
The FDA cleared Abbott’s launch of the Confirm Rx, first smartphone-compatible insertable cardiac monitor.
Patients can connect the implant to their smartphone using Abbott’s myMerlin mobile app to enable continuous monitoring of their heart rhythms. The device transmits data to a physician via the mobile app on a set schedule.
OptiScan Biomedical’s OptiScanner 5000 Receives 510(k) Clearance
OptiScan Biomedical won 510(k) clearance for the OptiScanner 5000 glucose monitoring system.
The device monitors plasma glucose levels and determines dysglycemia in surgical intensive care unit patients. The bedside system enables physicians to manage patient glucose levels in the ICU.
The OptiScanner 5000 previously received CE Mark certification for use in the EU.
Viveve Wins Approval for Viveve System in Mexico
Viveve Medical received approval from the Mexican regulatory authority, COFEPRIS, to market its Viveve System. The device is used for treatment of vaginal introital laxity after childbirth.
The device has been cleared in more than 50 countries. The company plans to submit an investigational device exemption to the FDA to conduct a pivotal trial.
Medizone International Receives CE Mark for AsepticSure Disinfection System
Medizone International received CE mark approval for its AsepticSure disinfection system.
The system combines oxidative compounds (O3 and H202) to produce a mixture of free radicals (trioxidane) with much higher oxidative potential than ozone or hydrogen peroxide alone.
Medizone has released the system for use in Canada, and several other global markets.
Australia Approves Anika’s Monovisc for Treatment of Osteoarthritis Pain
Anika Therapeutics was granted regulatory approval in Australia for Monovisc, its single injection viscosupplement for the treatment of pain associated with osteoarthritis of all synovial joints, including the hip and knee.
The device is already available in more than twenty countries, including the United States, Canada, and various European countries. It was recently approved in India and Taiwan.
Creavo Medical Secures 510(k) Clearance for Vitalscan
Creavo Medical Technologies received FDA 510(k) clearance for Vitalscan, a device used to scan for chest pain in patients.
The battery-powered, portable device uses magnetocardiography to scan at a patient’s bedside to help physicians rule-out ischemic heart disease. Vitalscan displays and stores electromagnetic fluctuations caused by heart activity.
DarioHealth Gains CE Mark for iPhone-Compatible Smart Glucose Meter
DarioHealth received a CE Mark for its Dario blood glucose monitoring system.
The device is compatible with the iPhone 7 and iPhone 8.
The company is seeking approval for the device in the U.S., Canada, and Australia.