Drugs
Although Stericycle predicted a drop in product recalls during the Covid-19 shutdown of the U.S. economy that started at the end of the first quarter, recalls continued at their typical level, according to the company’s second-quarter report. The report section on medical devices says those companies
Devices
FDA has approved a Med-EL USA PMA supplement for the Rondo 3 Audio Processor for use with its Synchrony Cochlear Implant System. The company says the Rondo 3 offers wireless streaming, wireless charging with a rechargeable battery that lasts up to 24 hours, and compatibility with all hearing aids
Devices
Smiths Medical has recalled specific software versions used with its Medfusion 3500 and 4000 Syringe Pumps because of an error that may lead to fluid/medication over delivery or under delivery. A recall notice says the delivery errors can occur if the following specific sequence of events occur: a bolus
Devices
FDA has cleared a Gyroscope Therapeutics 510(k) for the Orbit Subretinal Delivery System, indicated for microinjection into the subretinal space at the back of the eye. The microinjection procedure is designed to avoid damaging the structure of the eye by preventing the need for a vitrectomy, a procedure that
Devices
FDA has awarded HelixBind a breakthrough device designation for its RaPID/BSI, a direct-from-blood platform for identifying and characterizing bloodstream infections, such as sepsis. HelixBind says its breakthrough request focused on the features of the RaPID platform that distinguish the test from the current standard of care, such
Devices
Valencia Technologies has filed a PMA for its eCoin Peripheral Neurostimulator System for use in treating overactive bladder. The device is designed to provide intermittent electrical stimulation of the tibial nerve using a leadless nickel-sized implant. The PMA application that was accepted for filing by FDA was part of
Devices
FDA has cleared a Pelvital 510(k) for Flyte, an intravaginal home-use device that is intended to strengthen the pelvic floor muscles to help women with stress urinary incontinence (SUI). “Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-
Devices
FDA is alerting health care providers (HCPs) that the use of passive protective barrier enclosures (those without negative pressure) when treating Covid-19 patients may pose an increased health risk to patients and other HCPs. The agency says it has become aware of “preliminary evidence in simulated intubation procedure models
Devices
HHS said 8/20 that under a Trump Administration deregulation initiative, FDA will no longer require premarket review of laboratory-developed tests (LDTs), including tests to detect the virus that causes Covid-19. It’s a major policy change made without notice and comment rulemaking. Attorneys Gail Javitt and Jeffrey
Biologics
Interviewed on WILX in Lansing, MI, FDA commissioner Stephen Hahn continued his efforts to reassure the public that there has been no political pressure on FDA to speed a vaccine approval and that only scientific data will be used to make such a decision. He reiterated that the speed in
Devices
An FDA 7/29 final guidance on the regulation of medical devices with multiple functions is largely similar to an earlier draft but with further clarification about the agency’s expectations for the device manufacturer risk assessment processes, including new language on assessing cybersecurity risks associated with non-device functions,
Devices
A Bayer official warned the company of increased FDA scrutiny of injuries from its Essure implanted contraceptive device before it was withdrawn from the market, according to recently unsealed court documents reported by Bloomberg News. The news service reports that a company product surveillance senior manager said in an internal
Devices
FDA has updated its alert on breast implant adverse events to include new reports received through 1/5. An updated table on the agency’s breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Web page now includes a total of 733 unique cases and 36 patient deaths globally, which
Devices
FDA has cleared an IlluminOss Medical 510(k) for its Photodynamic Bone Stabilization System for treating fibula fractures. IlluminOss says the device is a patient-specific intramedullary implant that has a light-curable liquid monomer, contained within an expandable balloon, to create a patient-conforming, rigid implant within the bone
Devices
FDA has cleared a Hyperfine Research 510(k) to expand the use of its portable Swoop MRI imaging device. The point-of-care imaging device can be wheeled to a patient’s bedside, plugs into a standard wall outlet and is controlled through a wireless tablet. Hyperfine says the clearance
Devices
FDA has announced an 11/13 public workshop entitled “Orthopedic Device-Related Infections.” The agency says the workshop is the first of a series planned to improve public understanding of infections related to orthopedic devices and appropriate mitigation measures for protecting and promoting public health in this clinical area. It
Devices
FDA has cleared a 23andMe 510(k) for a pharmacogenetics report on interpretive drug information for two drugs — heart drug clopidogrel and depression drug citalopram. The clearance modifies the labeling of the company’s 23andMe CYP2C19 Drug Metabolism Report, removing the need for confirmatory testing and allowing the company to
Devices
FDA has posted a catalog of regulatory science tools to help sponsors assess new medical devices. The catalog “collates a variety of regulatory science tools” that CDRH’s Office of Science and Engineering Labs developed and plans to expand as new tools become available. The tools include: * Laboratory methods * Computational
Devices
FDA has issued an emergency use authorization to Yale School of Public Health for its SalivaDirect Covid-19 diagnostic test. The test does not require any special swab or collection device; a saliva sample can be collected in any sterile container, an FDA release says. It is also “unique” because
Devices
FDA is alerting clinical laboratory staff and health care providers about a risk of false results with Thermo Fisher Scientific TaqPath Covid-19 Combo Kit based on two issues related to the test kit and its associated Applied Biosystems Covid-19 Interpretive Software. The test is a molecular assay for
Drugs
FDA has issued a final guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The document outlines how the agency plans to identify whether responsible parties have failed to submit required clinical trial registration or results information to ClinicalTrials.gov. It also discusses how it will identify
Devices
FDA has posted a device shortage list which was mandated as part of the recent coronavirus-related CARES Act. The listing reflects devices that FDA has determined to be in shortage and will be updated as the Covid-19 pandemic evolves. In addition, the agency includes a listing of medical