Devices
FDA has issued a letter to health care providers that updates risk information for gastric balloon devices used for weight loss. Results from two FDA-required post-approval studies provide updated information on two specific risks — device over-inflation or spontaneous hyperinflation, and sudden pancreas inflammation (acute pancreatitis). “FDA wants
Devices
FDA has granted a Bayer request for a variance from some medical device reporting requirements, specifically reportable adverse events Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding its controversial Essure contraceptive. The agency issued a letter to Bayer outlining conditions for
Devices
FDA has asked a Massachusetts federal court to lift portions of a consent decree affecting Royal Philips and its Emergency Care and Resuscitation business to allow the company to resume manufacturing and shipping external defibrillators for the U.S. market. The 11/2017-ordered decree (see earlier story) suspended external
Devices
FDA has posted a new guidance entitled “Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The document is intended to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology
Devices
FDA 4/23 issued an immediately-in-effect guidance to help increase availability and capability of imaging products needed for diagnosis and treatment monitoring of lung disease in patients with Covid-19. The agency said affected imaging products include medical x-ray, ultrasound and magnetic resonance imaging systems, and image
Devices
FDA has cleared a Cagent Vascular 510(k) for its Serranator PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The device uses the company’s serration technology in a semi-compliant balloon for treating peripheral artery disease, the company says. It is designed to create multiple longitudinal
Devices
Stakeholders say they support an FDA proposal to reclassify human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and human immunodeficiency virus nucleic acid diagnostic and supplemental tests from Class 3 to Class 2 with special controls. The Association of Public Health Laboratories says the change will “achieve urgently needed
Devices
FDA has granted Baxter International an emergency use authorization for the Oxiris filter set to treat patients who have confirmed Covid-19 and have been admitted to the intensive care unit with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including
Devices
FDA says that Trividia Health is recalling one isolated True Matrix Air blood glucose meter distributed in the U.S. to AssuraMed. An agency announcement says the company determined that the meter was packaged into a True Metrix blood glucose meter kit and has an incorrect factory-set unit of
Devices
FDA has posted a ventilator interactive review template, which can be used to provide information to FDA to support inclusion of an eligible product under an emergency use authorization (EUA). The ventilator EUA template is available here: Ventilator EUA Interactive Review Template. To ask questions about an EUA, emails can
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that additional clarify and increased consistency from FDA on the bridging of information approaches for drug-device and biologic-device single entity and co-packaged combination products promote efficiency in the development process that can lead to timely access to
Devices
FDA is likely regretting its policy introduced last month that allowed dozens of Covid-10 serology (antibody) tests to come onto the market without normal vetting or review under the agency’s emergency use authorization pathway. Now that the floodgate is open for test developers, 117 “unauthorized” antibody tests are
Devices
A 12/9-12/13/19 FDA inspection at the Tenderneeds Fertility medical device operations in Greenville, IN, found multiple violations in the firm’s work as an initial importer of devices and a manufacturer of several types of intrauterine insemination and intracervical insemination kits. A 4/13 Warning Letter
Devices
FDA has authorized the Laboratory Corporation of America (LabCorp) Covid-19 RT-PCR test to permit testing of samples self-collected by patients at home using the company’s Pixel home collection test kit. The agency reissued an emergency use authorization for the test, the first such test with a
Devices
FDA has issued a final guidance, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, to explain how an owner, operator, or agent in charge of a medical device establishment may submit a request for nonbinding feedback to FDA about actions the firm proposes to take to address certain kinds
Devices
To improve FDA’s emergency use authorization (EUA) for Covid-19 serology (antibody) tests, the agency says it is working on EUA templates that laboratories and commercial manufacturers may use to facilitate the preparation and submission of such requests. The serology tests will likely play a huge role in identifying
Devices
FDA has postponed a 5/5-planned public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027.” The meeting, which was set to take place by Webcast only, will now be rescheduled at a later date. The meeting was scheduled to discuss proposed recommendations for reauthorizing
Drugs
FDA commissioner Stephen Hahn says that to date the agency staff has been performing user fee review activities despite also being heavily involved in Covid-19-related activities. In a statement, Hahn says that part of the review activities has involved looking at ways to use technology and established agreements
Devices
FDA has granted an emergency use authorization for Synapse Biomedical and its TransAeris Diaphragmatic Pacing Stimulator System that is intended to help wean patients off ventilators, including COVID-19 patients. Diaphragm pacing can free up ventilators as patients are moved off ventilators and placed on the pacing system, the company
Devices
FDA has granted emergency use authorizations to two Covid-19 antibody tests — Chembio Diagnostic System’s DPP COVID-19 IgM/IgG System and Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. The two serology tests will aid in determining whether somebody has already been exposed
Devices
Viveve Medical says it has resubmitted to FDA its IDE for approval to begin a stress urinary incontinence (SUI) multi-center trial now known as PURSUIT (Prospective U.S. Radiofrequency SUI Trial). The company says the trial is designed to evaluate the safety and efficacy of Viveve's CMRF
Drugs
Two stakeholders are suggesting changes in an FDA draft guidance on bridging for drug-device and biologic-device combinations. AdvaMed’s comment letter commends the agency for implementing the guidance and offers “minor revisions to improve the clarity and impact” of the document. The Biotechnology Innovation Organization says the draft