Devices
FDA has approved an Illumina PMA for its Extended RAS Panel, a next-generation sequencing kit that is intended to be used on the Illumina MiSeqDx System to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Amgen’s Vectibix (panitumumab). “Together with Amgen, we’
Devices
FDA has cleared a Thermo Fisher Scientific 510(k) for its microbroth dilution plate for antimicrobial susceptibility of Gram negative organisms, including two of the latest novel compounds — ceftolozane/tazobactam and ceftazidime/avibactam. The plate enables microbiology laboratories to measure true minimum inhibitory concentration (MIC) values of 24 antimicrobials, which
Devices
The Office of the National Coordinator says that in the event of a ransomware attack involving a healthcare facility’s medical devices, FDA should be contacted at its emergency number 1-866-300-4374. Reports of impact on multiple devices should be aggregated on a system/facility level, it says.
Devices
Former FDA associate commissioner Joshua Sharfstein says the controversy involving power morcellators and the risk of unexpected uterine sarcoma “serves as a reminder that every procedure and medical device has the potential for both benefit and harm.” Writing in the Journal of the American Medical Association, Sharfstein and two other
Devices
FDA has allowed the marketing of Beckman Coulter’s ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in detecting several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome and myeloproliferative neoplasms. “Laboratories and
Drugs
The Clinical Trials Transformation Initiative (CTTI) has released recommendations and tools to provide a pathway for using information gathered from mobile technologies to accelerate development and evaluation of new therapies. The recommendations and tools are designed to help diverse stakeholders identify and develop novel endpoints based on data from mobile
Devices
FDA has cleared a Quidel 510(k) for the Sofia RSV Fluorescent Immunoassay to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of respiratory syncytial virus infections in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic pediatric patients. The company says Sofia
FDA Policy/General
An 11/7-11/10/16 FDA inspection at Pulmonary and Sleep Center of the Valley, McAllen, TX, conducted as part of the Bioresearch Monitoring Program, determined that the center did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection
Devices
FDA has cleared a Spineology 510(k) for the Rampart One Anterior Lumbar Interbody Fusion System. The device is designed to minimize the exposure and vascular retraction requirements associated with traditional anterior spinal fusion procedures, according to the company. It features both standard and oblique interbody device footprints each with
Devices
FDA has granted a portion of an Orthopedic Surgical Manufacturers Association 8/9/09 petition seeking reclassification of pedicle screw systems for certain uses from Class 3 to Class 2. The association had asked FDA to reclassify the systems for these intended uses: to provide immobilization and stabilization of spinal
Devices
The Advanced Medical Technology Association (AdvaMed) has filed an amicus curiae brief urging the U.S. Supreme Court to hear the case of Ethicon v. Huskey in order to correct lower courts’ refusal to allow 510(k) clearance requirements as evidence in product liability cases. The case involves a Fourth
Devices
CDRH has posted a new medical device education module to its CDRH Learnprogram Web site — Electronic Submission of 806 Reports of Corrections and Removals. Under 21 CFR 806, Medical Devices; Reports of Corrections and Removals, manufacturers and importers are required to report any correction or removal of a device if
Devices
FDA has approved a Roche PMA for its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay. The assay is intended for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1 (HIV-1 groups M and O) and HIV-2
Devices
FDA has cleared an Insulin Algorithms 510(k) for its decision-support software, which helps clinicians manage every type of insulin for diabetes treatment. The company says the software makes it easy for a clinician to regularly analyze a patient’s blood sugar measurements and quickly optimize the insulin regimen.
Devices
FDA has cleared a K2M Group Holdings 510(k) for its Mojave PL 3D Expandable Interbody System, a 3D-printed expandable posterior-lumbar interbody system that features the company’s Lamellar 3D Titanium Technology. The fusion device is designed to allow for independent control of the anterior and posterior height
Devices
Merit Medical Systems has received de novo clearance from FDA to expand the indication for its Embosphere Microspheres to now include prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia. The PAE procedure is performed through a tiny incision in the patient’s upper thigh or wrist, and uses Embosphere
Devices
FDA has approved LivaNova’s VNS Therapy systems for expanded MRI labeling, allowing patients to visit any MRI center in the U.S. and have access to more than 90% of scans routinely performed on patients with epilepsy. Previously, approved labeling allowed patients to obtain MRI scans only with the
Drugs
Eighty-eight patient- and disease-focused organizations say they support FDA for recognizing the need for a central Office of Patient Affairs to coordinate opportunities for patient involvement in medical product development and regulation at the agency. While the groups say the new office will be essential to success of
Drugs
Two Shook, Hardy & Bacon attorneys say that a review of new Supreme Court justice Neil Gorsuch’s 10th Circuit Court of Appeals preemption appeals indicate that his appointment should help maintain the status quo as it relates to preemption jurisprudence. “More significantly,” they write in a Washington Legal Foundation
Devices
Vascular Solutions has begun a recall of its Venture catheter because there is a risk of the catheter tip splitting or separating during use. “Excess material at the tip of the catheter may separate and could enter the patient’s bloodstream,” a recall notice says. “This can result in serious
Drugs
FDA has issued a draft guidance with questions and answers providing guidance to sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic records and electronic signatures in clinical investigations of medical products. The document clarifies, updates, and expands upon recommendations in a 2003
Devices
FDA has just released Zimmer Biomet’s detailed 12/21/16 response to observations in an FDA-483 issued 11/22/16 following an inspection at the company’s Warsaw North Campus in Warsaw, Indiana. “We recognize and take seriously the significance of the observations in the FDA-483, are