Devices
Imarc, a medical device contract research organization, says that FDA Bioresearch Monitoring metrics for FY 2017 show that 36% of the inspected sponsors, monitors, or contract research organizations had some type of deficiency resulting in either a Voluntary Action Indicated outcome or an Official Action Indicated outcome. In a report,
Devices
GE Healthcare has recalled all Giraffe Warmers and Panda iRes Infant Warmers because bedside panels and latch areas on beds may crack, break or become damaged by using the bedside panels to move the warmer instead of using the front handle or the rear maneuvering handle. GE says users should
Devices
FDA has approved a Philips PMA for its HeartStart OnSite defibrillator and HeartStart Home defibrillator and the relevant supporting accessories. The company says the two defibrillators are the only over-the-counter automated external defibrillators available to consumers in the U.S. Also, the HeartStart Home defibrillator is the only
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Lateral Expandable Spacer System for use in treating spinal disorders. The device, which is available in several lordotic options, allows for post-packing in situ, has anatomically convex endplates and is made using Life Spine’s proprietary Osseo-Loc
Devices
Cook Medical has recalled its Advance Enforcer 35 Focal-Force PTA Balloon Catheter (6mm x 4cm) after multiple complaints were received about balloons bursting below the rated burst pressure. The company says that while there have been no reports of malfunctions, deaths, or injury reported for the balloon issue, there
Drugs
FDA scientists say they have developed a poliovirus assay that is faster and more versatile than those now used to monitor polio vaccine production, assess patient responses to polio vaccines during clinical trials, and do environmental surveillance of vaccine poliovirus. They say the new assay also is the first to
Devices
Department of Homeland Security’s National Cybersecurity and Communications Integration Center has issued a cybersecurity alert on BD’s Alaris Gateway Workstation, which is used to integrate infusion pump systems with hospitals’ central clinical information systems. The cyber threat could “allow unauthorized arbitrary code execution, which could allow an attacker
Devices
FDA has granted Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based liquid biopsy test to receive such a designation. The breakthrough program is designed to expedite the development, assessment and review of certain devices through interactive and
Devices
FDA has approved Cochlear Limited’s new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor’s new built-in connectivity featuring direct streaming with compatible Android smartphones. The device is designed for safe access to magnetic resonance imaging scans without the need to remove the
Devices
Patients and consumers worried about dental amalgam’s mercury content and its risks have taken on a campaign to urge FDA action by submitting almost 200 comments to an agency docket seeking input on Patient Preference Information related to medical device regulatory decisions. As of 6/14, 94% of comments
Devices
FDA is publishing a draft guidance, Testing for Biotin Interference in In Vitro Diagnostic Devices, with agency recommendations. The document is intended to help medical device developers and clinicians understand how the agency recommends biotin interference testing should be performed and how the results of testing should be communicated to
Devices
FDA has cleared a Materialise 510(k) for its Mimics Enlight cardiovascular planning software suite. “The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures,” the company says. The device is intended to support patient selection and planning for structural heart and vascular therapy. “The TMVR
Devices
FDA has released a draft guidance on “Mouse Embryo Assay for Assisted Reproduction Technology Devices.” The document outlines recommendations on conducting the mouse embryo assay (MEA) to support premarket submissions and lot release of assisted reproduction technology (ART) devices. The majority of ART devices directly or indirectly contact gametes (i.
Devices
FDA has cleared an Applied BioCode 510(k) to permit the use of Roche’s MagNA Pure 96 Extraction System with the high throughput BioCode MDx-3000 and Gastrointestinal Pathogen Panel (GPP). Previously, BioCode’s devices were cleared for use on bioMerieux’s Nuclisens easyMAG extraction system. Applied BioCode says
Devices
FDA has cleared a CorMatrix Cardiovascular 510(k) for the Cor Patch, indicated for epicardial tissue support and repair in adult patients. The device is intended for epicardial support and repair of atria and/or the right and left ventricular walls of the heart that have been thinned or damaged
Devices
GE Healthcare says artificial intelligence/machine learning (AI/ML) “is set to revolutionize healthcare. Device manufacturers are embracing AI/ML to create new medical devices and transform the way medical devices function in the healthcare environment.” Responding to an FDA discussion paper and request for feedback, the company says the
Devices
A 6/11-7/5/18 FDA inspection at OriGen Biomedical, Austin, TX, for Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of dual lumen catheters, including the Reinforced Dual Lumen ECMO catheter. A just-released 12/20/18 Warning Letter says specific violations were:
Devices
FDA has cleared an EmCyte 510(k) for its PureBMC Supraphysiologic Concentrating System for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate through centrifugation. Bone marrow’s platelet and cell concentrate is the strongest autologous biologic prepared at the
Devices
FDA has cleared a Masimo 510(k) for its O3 Regional Oximetry for use on neonatal and infant patients. The device is intended to help clinicians monitor cerebral oxygenation in situations where peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain, Masimo says The
Devices
Former Advanced BioHealing chairman and CEO Kevin Rakin has agreed to pay the government $2.5 million to settle False Claims Act allegations that he knowingly allowed company sales representatives to use kickbacks and other unlawful methods to induce clinics and physicians to use or overuse its Dermagraft product. The
Devices
FDA has cleared an Innovative Health Solutions de novo marketing request for the IB-Stim, the first medical device to aid in reducing functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. “This device offers a safe
Devices
FDA has cleared an Akonni Biosystems 510(k) for its TruDiagnosis System, a compact point-of-service molecular diagnostic device which includes the TruDx 2000 Imager and the TruArray consumable test kit. The saliva test is intended to identify genetic signatures associated with patient metabolization of the drug Coumadin, which