Approvals

FDA Clears New Parameter for Terumo’s Blood Monitor

The FDA granted clearance to Terumo Cardio’s CDI blood parameter monitoring system to monitor oxygen delivery in real-time.

The device is now approved to measure 12 critical blood parameters.

Measuring oxygen delivery is used during cardiopulmonary bypasses to help reduce acute kidney injury, a common complication of cardiac surgery.

Beckton Dickinson Gets Clearance for CPO Detection Test

BD’s Phoenix carbapenemase-producing organism (CPO) phenotypic detection test received marketing clearance from the FDA.

The device is the latest addition to BD’s diagnostics product line, which includes the BD Phoenix M50, an automated microbiology system used to test susceptibility.

The phenotypic detection test is used to identify CPO-caused infections. It can deliver results in less than 36 hours and may be faster than conventional phenotypic methods.

Abbott’s Neuropathic Pain Blocker Cleared for Marketing

The FDA and EU have both cleared Abbott’s DRG Invisible Trial system for marketing, a device designed to help people suffering from neuropathic pain.

The device targets the dorsal root ganglion (DRG), a nerve structure near the spinal cord that transmits chronic pain to the nervous system.

By transmitting electrical pulses through a thin wire placed in the spinal column near the DRG, the system blocks pain signals from reaching the nervous system.

FDA Grants PMA for QView Medical’s Automated Breast Ultrasound System

The FDA has given premarket approval for QView Medical’s GE Invenia 3D automated breast ultrasound system (ABUS), designed for dense breast screening.

Breast density can increase the risk of breast cancer in women and make screening more difficult.

The device is meant for breast screening in asymptomatic dense breasted women whose mammograms returned negative.

Canon Medical’s MRI System Cleared

The FDA granted 510(k) clearance for Canon Medical’s Vantage Orion 1.5 Tesla magnetic resonance imaging (MRI) system.

The device includes new technology meant to improve productivity, patient comfort and clinical confidence.

The system uses rapid scan technology, a dockable table for improved patient handling, high resolution imaging and advanced diagnostic technology.

FDA Clears SIG Medical’s Anterior System

The FDA granted 510(k) clearance to SIG Medical’s AdvantageRib anterior system, a minimally invasive system designed to treat rib fractures.

The AdvantageRib comes with titanium plates and screws used to treat rib fractures with an anterior approach. The system’s adaptable straight plates allow for custom fits in challenging clinical situations and the titanium screws are designed for ribs of all sizes.

The clearance marks the second rib fracture system the Hershey, Pennsylvania devicemaker is commercializing.

Philips’ Ventilator System Gains CE Mark

Philips received CE Mark approval for its V60 Plus ventilator system, used for early interventions into respiratory failure.

The system features both noninvasive ventilation and high flow therapy, which allows it to be used with changing patient conditions without having to switch devices.

The device allows for quick therapy and interface transitions and lessens the time physicians need to use for equipment set up.

Implanet Receives CE Mark for Jazz Cap System

Implanet received the CE Mark for its Jazz Cap System, a device for securing screws in poor-quality bone.

The single-use, sterile implants were developed for the main purpose of supporting the treatment of degenerative conditions in adult patients.

The system includes a set of implants consisting of a screw, a band and the company’s patented locking mechanism.

ThermoGenesis Gains Marketing Clearance for Blood Banking Platform

Cesca Therapeutics subsidiary ThermoGenesis received 510(k) clearance from the FDA for its AXP II AutoXpress platform for clinical blood banking and harvesting of stem and progenitor cells.

The AXP II is the next-generation of the original AXP system, which received market clearance in 2007.

The upgraded platform features an improved docking station and XpressTRAK software for regulatory compliance. ThermoGenesis is developing an automated CAR-TXpress platform to streamline the manufacturing process for the emerging CAR-T immunotherapy market.