Devices
FDA has approved an expanded indication for Cardiva Medical’s Vascade vascular closure system for use in 5-7F femoral venous closures as well as for arterial closure. The company says the expanded indication “creates an opportunity to better treat patients undergoing interventional cardiac catheterization procedures, while also greatly increasing
Devices
An Arizona federal jury has awarded a plaintiff $3.6 million in a bellwether case involving C.R. Bard’s inferior vena cava (IVC) filter. District Court judge David Campbell limited plaintiff Sherr-Una Booker’s claims to defective design, failure to warn, and punitive damages. Booker had the device
Devices
FDA has cleared an Aesku Group 510(k) for its Aeskuslides nDNA (Crithidia luciliae) assay and its use on the company’s new Helios Automated IFA System. The kit is the second clearance for its immunofluorescence assay on the Helios, after its ANA HEp-2 cleared in 2016. Immunofluorescence assays
Devices
At the 3/30 meeting of the FDA Clinical Chemistry and Clinical Toxicology Devices Advisory Panel, members indicated that the benefits of using glucose meters for measuring blood glucose in capillary blood in patients receiving intensive medical intervention/therapy outweigh the risks. The comment came in response to FDA’s
Devices
FDA has approved a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for patent foramen ovale (PFO) closure to prevent recurrent ischemic strokes. The device was previously approved for closure of atrial septal defects up to 17 mm. The expanded was supported by data from the REDUCE
Devices
AdvaMedDx says it appreciates what FDA has done to review and clarify its policies on study designs that can support both 510(k) and CLIA waiver applications. In comments, it notes that it also commented on a related docket on select updates for recommendations for CLIA waiver applications for manufacturers
Devices
FDA has approved an Abiomed PMA for its expanded Impella CP heart pump with SmartAssist. The device includes advanced software and new optical sensor that is intended to improve real-time, exact positioning for the pump and allows for repositioning without the need for imaging equipment, according to the company.
Devices
FDA has cleared a Zimmer Biomet Holdings 510(k) for its Comprehensive Augmented Baseplate, which is intended to offer an alternative to bone grafting and eccentric reaming for patients with glenoid defects undergoing shoulder reconstruction. The device features a simplified circular design at three augment heights (3mm, 5mm and 7mm
Devices
FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee has voted unanimously to recommend approval of Senseonics Holdings’ Eversense, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes. The device uses a sensor that can last up to 90 days. The company demonstrated the safety,
Devices
Three industry stakeholders say they appreciate an FDA draft guidance on investigational IVDs (in vitro diagnostics) and suggest changes they would like in the draft. The Biotechnology Innovation Organization (BIO) says in a 3/19 comment letter that it appreciates that the guidance provides several examples of IVD uses that
Devices
FDA has approved a Hologic PMA for its Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology and their use on the company’s 3Dimensions breast tomosynthesis system. The company says the imaging technology provides fast high-resolution 3D images to accelerate screening and analysis, and it is
Drugs
FDA has published the annual report on information related to inspections of facilities necessary for approval of a drug or medical device required by the 2017 FDA Reauthorization Act. The report shows that: * median time between inspection request from FDA staff reviewing a drug application or report to the beginning
Devices
CDRH reviewed in a 3/20 Webinar contents of two updated guidances that implement provisions of the 21st Century Cures Act — the acceptance and filing a review for PMA applications guidance and the refuse-to-accept policy for 510(k) guidance. CDRH Office of Device Evaluation policy analyst James Bertram
Devices
FDA has cleared a Canon Medical Systems USA 510(k) for a suite of quantitative tools to assess the spectrum of liver disease (including steatosis, inflammation and cirrhosis) on the company’s Aplio i800 ultrasound system. In addition to Shear Wave Elastography imaging, the new suite adds Attenuation Imaging and
Devices
The Justice Department says Alere will pay the federal government $33.2 million to resolve allegations that it caused hospitals to submit false claims to federal healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices. A government False Claims Act complaint said that between 1/2006
Devices
FDA says it has allowed the marketing (de novo process) of the first fully interoperable continuous glucose monitoring system. Dexcom’s G6 integrated continuous glucose monitoring (iCGM) system is intended to determine blood glucose levels in children aged two and older and adults with diabetes, according to an agency news
Devices
FDA has cleared a Bioness 510(k) for the myBioness mobile app for use with its L300 Go System, a functional electrical stimulation system that offers 3D motion detection of gait events and muscle activation using data from a three-axis gyroscope and accelerometer. Bionesss says the mobile app is
Devices
Becton Dickinson has recalled its BD Vacutainer Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the stopper that interferes with the accuracy of Anodic Stripping Voltammetry (ASV) testing methodology. ASV is the methodology used in Magellan Diagnostics’ LeadCare Testing Systems that
Devices
FDA has cleared an Auris Health 510(k) for the Monarch Platform to assist with diagnostic and therapeutic bronchoscopic procedures for treating lung cancer. The device is designed to enable accurate diagnoses and treatment of small and hard-to-reach nodules in the periphery of the lung, the company says.
Devices
FDA has cleared a Delta Med 510(k) for the DeltaVen Closed System Catheter. The peripheral intravenous device has a needle, extension tubing, and an option for a needleless connecter to the catheter. It will be available in a variety of sizes and configurations, including the only 26 gauge safety
Devices
Unexpected heating of laser delivery probes has led to a Monteris Medical recall of its NeuroBlate system and laser delivery probes. The system is used during brain surgery to ablate, coagulate, or necrotize brain tissue cells. The recall covers 52 devices manufactured and distributed between 4/2013 and 7/2017.
Devices
FDA says that based on studies conducted by Becton Dickinson (BD), it continues to recommend that Magellan Diagnostics lead tests not be used with blood samples taken from the vein. A statement by CDRH Office of In Vitro Diagnostics and Radiological Health acting director Donald St. Pierre says that Magellan’