Approvals

FDA Authorizes In Vitro Devices for Zika Detection

The FDA has issued two emergency use authorizations for in vitro diagnostic devices used to detect the Zika virus.

In February 2016, the HHS determined Zika presented significant potential for a public health emergency. In light of this, the FDA has issued emergency use authorizations for DiaSorin’s Liaison XL Zika Capture IgM Assay and Nanobiosym Diagnostics’ Gene-RADAR Zika Virus Test.

The agency also revoked its authorization for Roche’s LightMix Zika rRT-PCR Test, at Roche’s request.

FDA Clears Summit’s Jaw Fracture Recovery Device for Marketing

Summit Medical’s non-invasive jaw fracture recovery device secured FDA clearance for widespread marketing.

The device uses a system of sutures between the teeth to fix the jaw in place evenly for the recovery process. The use of sutures is more efficient and comfortable than wire-based devices, which can pose a safety threat to patients and surgeons. The device could also potentially be applied in clinical settings rather than operating rooms, reducing costs and delays.

Brazilian Regulator Approves Waters Corp’s Spectrometry, UPLC Systems

Brazil’s National Health Surveillance Agency (ANVISA) has approved Waters Corporations’ mass spectrometry and UPLC systems for in-vitro diagnostic use.

The devices the approval makes available include the Acquity UPLC I-Class/Xevo TQD IVD System, the TQ-S micro IVD System and the TQ-S IVD System.

FDA Clears Cooling Cap for Solid Tumor Cancer Patients

The FDA cleared the expanded use of Dignitana’s DigniCap Cooling System to reduce hair loss during chemotherapy for cancer patients with solid tumors.

The computer-controlled system is used during the chemotherapy treatment. The cap is worn on the head and circulates liquid to cool the scalp. A second cap made from neoprene holds the cooling cap in place and acts as insulation.

The cooling is intended to constrict blood vessels in the scalp, which reduces the amount of chemotherapy that reaches cells in the hair follicles. The cold temperature also decreases the activity of the hair follicles and slows down cell division, making them less affected by chemotherapy.

Edwards Lifesciences Gets FDA Nod for Inspiris Resilia Valve

The FDA has approved Edwards Lifesciences’ Inspiris Resilia aortic valve.

The approval follows a pivotal trial in which two-year data from nearly 700 patients showed no indications of valve thrombosis, nonstructural valve dysfunction or structural valve deterioration.

The company expects to market the device on the U.S. early next year. It is already available in Europe and a launch is planned later this year in Japan.