Product Approval Summaries
DEVICES
Accuray Inc. has received FDA 510(k) clearance for its Radixact Treatment Delivery Platform and its new treatment planning and data management systems, Accuray Precision Treatment Planning System and iDMS Data Management System. The company says these next generation hardware and software solutions make up the new Radixact system, which enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing retreatment.
FDA has cleared NDS’s ZeroWire G2 wireless technology solution embedded wireless HD-video receiver to be integrated into an endoscopy display. The company says it will be design engineered into the new Radiance Ultra series of premium endoscopy displays as an option within the display enclosure. It adds that by embedding the wireless video receiver into the endoscopy display, NDS has further streamlined the efficiency of the modern operating room, allowing for a reduction in the number of external medical devices required during a surgical procedure, as well as a reduction in power and video cables.
Roche has received FDA 510(k) clearance for its Elecsys Brahms PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. “PCT is a sepsis-specific biomarker associated with bacterial infection and PCT levels in blood can aid clinicians in assessing the risk of sepsis as well as managing the disease when present,” the company says. The test can aid in assessing the risk of critically ill patients progressing from severe sepsis to septic shock; and help determine the 28-day mortality risk in sepsis patients, it says.
FDA has granted 510(k) clearance to QT Vascular Ltd. for the sale and distribution of the Chocolate XD PTCA catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis. According to the company, the Chocolate platform utilizes a unique nitinol constraining structure that is mounted on a semi-compliant balloon and is designed to reduce vessel trauma by providing a balloon inflation that is predictable, controlled, and uniform.
HUMAN DRUGS
FDA has approved an Allergan supplemental NDA for Avycaz (ceftazidime and avibactam) to include clinical data from a Phase 3 trial evaluating the drug’s use in combination with metronidazole for treating complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms. Avycaz was first approved in the U.S. 2/2015 for treating adult patients with cIAI, in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa.
FDA has approved an Opko Health NDA for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. The submission was given a complete response letter (CRL) in March that cited manufacturing deficiencies at Opko’s third-party contract manufacturer found during a 3/14 agency inspection. “The CRL did not cite any safety, efficacy or labeling issues with regard to Rayaldee, nor did it request any additional studies to be conducted prior to FDA approval,” the company said at the time. In April, the company resubmitted the application, saying that it had worked closely with its third party manufacturer to ensure FDA’s concerns were promptly and fully addressed.