Approvals

LivaNova Receives CE Mark for Nerve Stimulation Device

LivaNova received a CE Mark for its vagus nerve stimulation therapy system SenTiva generator for treating drug-resistant epilepsy.

The implantable device can detect seizures and automatically deliver an extra dose of therapy. The generator is also designed to log events including a patient’s body position and heart rate fluctuations. The system includes a tablet and a wireless programming wand.

The product received FDA clearance in October 2017.

CE Mark Granted for Hematology Analyzer

Beckman Coulter Diagnostics received a CE Mark for its DxH 520 hematology analyzer.

The company used its flagship DxH 800 analyzer as the predicate product for the DxH 520. The system uses just two reagents and includes on onboard cleaner.

The analyzer is pending clearance by the FDA, so it not yet available for in vitro diagnostic use in the United States.

Cantel Medical Earns 510(k) Clearance for Endoscope Reprocessor

Cantel Medical received FDA 510(k) clearance to market its automated endoscope reprocessor, which helps prevent infections from endoscopic procedures.

The Advantage Plus Pass-Thru automated endoscope reprocessor can disinfect commonly used endoscopes, including duodenoscopes, and it features a one way workflow.

The hands free operation reduces scope handling and allows reprocessing of four to five scopes in an hour. The device has been validated for use with Cantel’s Rapicide PA disinfectant.

FDA Clears Arthrosurface’s Shoulder Arthroplasty System

Arthrosurface’s Ovomotion shoulder arthroplasty system received 510(k) clearance from the FDA for marketing and is cleared for use with the novel Arthrosurface Inlay Glenoid System.

It is designed for patients with painful or severely disabled shoulder joints caused by arthritis, traumatic events or avascular necrosis.

The stemless total shoulder system enables surgeons to minimize bone removal.

FDA Authorizes First Test for Candida Auris

The FDA authorized the first test for identifying Candida auris, a multidrug resistant pathogen that can cause serious infections in hospitalized patients.

The agency approved a new use of the Bruker Maldi Biotyper CA system for identifying the pathogen, expanding the system’s uses to 424 clinically relevant bacteria and yeast species.

The system uses mass spectrometry in combination with a reference organism database.

Lumendi Receives 510(k) Clearance for Endoscopic Accessory

The FDA gave Lumendi 510(k) clearance for its DiLumen C2 device, an endoscopic accessory used to ensure complete positioning of an endoscope in the large intestine.

The DiLumen C2 uses two 6mm diameter tool channels which accommodate two flexible articulating hand instruments.

SurModics Gets FDA Clearance for Balloon Dilation Catheter

The FDA granted SurModics 510(k) clearance for its 0.18” low-profile percutaneous transluminal angioplasty balloon dilation catheter.

The device is indicated for use in peripheral vascular applications ranging from 2mm to 10mm diameter.

FDA Clears Viz.ai’s CTP Image Processor

The FDA gave Viz.ai 510(k) marketing clearance for its automated CT perfusion image processor Viz CTP.

The processor allows the user to view dynamic CT perfusion images and offers automated large vessel occlusion (LVO) stroke identification and notification.

In addition, the Viz.ai system offers patient selection, HIPAA compliant communication, transport coordination and mobile medical image viewing.