Product Approval Summaries

DEVICES

FDA has cleared a Becton Dickinson 510(k) for the BD FACSPresto system and BD FACSPresto CD4/Hb Cartridge for use in testing CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to manage HIV/AIDS patients. The automated multicolor fluorescent imaging cytometer and absorbance spectrometer provides absolute and percentage results of CD4 T lymphocytes and Hb concentration, according to the company. It uses a proprietary dried reagents cartridge to offer increased stability across a wide range of storage conditions, it says. The system also includes a touchscreen, language-independent user interface and is able to process up to 80 tests in a normal day. After finger stick or venipuncture blood collection, samples are a single-use disposable cartridge with results available in less than four minutes.

FDA has cleared a Guerbet 510(k) for its OptiOne Single-Head Contrast Delivery System for CT imaging procedures. The device, which is available in ceiling-suspended and pedestal form, is designed for injecting radiopaque contrast agents in the vascular system to obtain diagnostic images in CT scan examinations. Each injection is delivered with a motor-driven syringe mechanism using a microprocessor to control the flow rate, volume, pressure and timing.

LifeWatch AG has received FDA 510(k) clearance for its continuous Vital Signs Monitoring Service, a wireless patch intended to allow for early detection of vital sign changes. Notifications on vital sign changes can enable faster interventions as well as increased nursing efficiency and higher patient satisfaction, according to the company.

MX Orthopedics has gained FDA 510(k) clearance for the dynaMX Compression Staple for fracture fixation. The device, which is made of “superelastic nitinol,” allows the surgeon to control the opening of staple legs, according to the company. There is no post-insertion tamping required, and it allows easy intraoperative removal (if needed), it says.

FDA has cleared an Optovue 510(k) for the AngioVue Imaging System, a dyeless technique for quickly visualizing abnormal blood vessels in the retina to help physicians determine an appropriate treatment course. The device allows users to image the motion of scattering particles, such as erythrocytes (red blood cells), using sequential Optical Coherence Tomography cross-sectional scans, which are repeated at the same location on the retina.

FDA has cleared a Spectranetics 510(k) for the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures. The device is designed to reduce blood loss if a tear occurs, including in the superior vena cava (SVC). The company says an SVC tear occurs in less than one half of 1% of lead extraction procedures. When it happens, the Bridge is intended to provide “temporary occlusion prior to a critical surgical intervention by deploying in under two minutes, occluding the SVC tear and stemming 90% of blood loss for at least 30 minutes,” it says.

Wenzel Spine has received FDA 510(k) clearance to market VariLift-LX as an interbody fusion device for stand-alone use in the lumbar spine. The device is designed to “simplify” to be implanted in a unilateral or bilateral capacity, it says. It has four large fenestrations and a bone graft chamber to promote vertebral fusion.

FDA has cleared a Zimmer Biomet Holdings 510(k) for the Unite3D Bridge Fixation System, a 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery. The company says its OsseoTi porous metal technology mimics the architecture of cancellous bone and the Unite3D serves as an alternative to traditional surgical plates, screws, and staples.

HUMAN DRUGS

Kremers Urban Pharmaceuticals has received FDA approval for ANDA for temozolomide capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug Merck’s Temodar capsules. Temozolomide is a chemotherapy agent used to treat a certain type of brain tumor.