Devices
FDA has granted Attune Medical a de novo marketing authorization for its ensoETM device and its use to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures. “This de novo authorization gives electrophysiologists a solution to proactively cool the esophageal wall during ablation procedures…,” the
Devices
FDA has published two draft guidances on testing of medical devices with indications associated with weight loss. An agency statement says that when finalized, the guidances are intended to provide: * recommendations for non-clinical testing to support premarket submissions for these devices; * recommendations about clinical study design for the devices;
Devices
FDA has cleared the Samsung Wellysis unit’s wearable electrocardiography (ECG) patch, S-Patch Ex. The ECG and heart rate recording device is designed for both at-home and clinical settings. The device uses Samsung Electronics’ next-generation bio-processor for capturing accurate ECG waveforms, according to the company.
Devices
Abbott is recalling (Class 1) its Proclaim and Infinity implantable pulse generators (IPGs) due to complaints from patients who are unable to exit MRI mode. The Patient Controller (iPhone/iPod) may lose the ability to communicate with its IPG while in MRI mode, a recall notice says. It adds that
Devices
A report submitted by the President’s Council of Advisors on Science and Technology to President Joseph Biden on “A Transformational Effort on Patient Safety” contains two recommendations for FDA action. The report says patient safety is an urgent national public health issue, with recent data showing about one in
Devices
Mallinckrodt has recalled its One-Way Valve, 22F x 22M due to reports about the devices not opening properly, which prevents or reduces the flow of ventilated air or oxygen. The device is part of the INOmax Delivery System, which delivers nitric oxide therapy gas into the tubes between the
Devices
FDA has approved a LimFlow PMA for its LimFlow System for treating patients with chronic limb-threatening ischemia (CLTI) who have no other suitable endovascular or surgical treatment options and are facing major amputation. The device allows transcatheter arterialization of deep veins (TADV) and it is designed to reestablish blood
Devices
FDA has issued its first Postmarket Device Safety-Related Communications report to Congress as mandated by the 2023 Consolidated Appropriations Act. The law requires the agency to publish annually a report on the number of postmarket device signals communications issued, the sources of data for such signals, and how such
Devices
FDA has granted S4 Medical a de novo authorization to market its esolution esophageal deviation device. The authorization was based on data from the EASY AF (Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation) study which demonstrated the device’s 84% reduction in esophageal injuries, according to the company. The
Devices
At the request of several Congressional requestors, the Government Accountability Office (GAO) has released a new report examining FDA and FTC’s oversight of medical device direct-to-consumer (DTC) advertising. The report could be an early signal of increased interest on Capitol Hill on regulatory enforcement of medical product
Devices
FDA is providing further clarification about a safety alert issued earlier this year that recommended against the use of certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with some of their surgical and pediatric face masks. Laboratory tests show these masks “do not meet
Devices
FDA has published a guidance, Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices—Part I: Evaluation and Testing Within a Risk Management Process, to provide further clarification and updated information on using the designated ISO standard to support applications to FDA. The agency says the document
Devices
Royal Philips and its U.S. subsidiaries, including Philips Respironics, have allocated $615 million under an agreement to resolve all “economic loss claims” in the U.S. Multidistrict Litigation (MDL) related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. This settlement, which is being filed in
Drugs
FDA has published a guidance, Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, with questions and answers on applying human factor engineering (HFE) principles to developing combination products. The document finalizes a 2/2016 draft and clarifies how the unique aspects of a combination product influence
Devices
FDA has granted Admetsys a breakthrough device designation for its automated glucose control and continuous blood diagnostics system. The device is intended to automatically measure multiple blood analytes, including glucose, in real-time with no patient blood loss. “From this, it creates an adaptive, computational model of each patient’s
Devices
FDA has published three draft guidances that, when finalized, will provide updated recommendations on specific aspects of the medical device 510(k) program. An online 510(k) update (contains links to the new guidances) says the drafts are “informed by a 2019 request for public feedback to continue to modernize
Devices
FDA has published a statement, Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Healthcare Providers, Device Manufacturers, and Distributors, with best practices for healthcare providers and systems, medical device manufacturers, and distributors to consider while preparing for natural disasters and other emergencies. In addition to specific recommendations for providers,
Devices
FDA has granted Xenex Disinfection Services a de novo marketing authorization for the company’s LightStrike+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot intended for use in reducing pathogens on non-porous, high-touch surfaces in healthcare environments. The robot uses a xenon lamp to create high-
Devices
FDA has cleared a Techsomed 510(k) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures and confirming ablation zones. The device uses the company’s BioTrace solution, an “end-to-end software solution for full visualization and control for image guided ablation therapy,” Techsomed
Devices
FDA has cleared a 23andMe 510(k) to expand its existing BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report by allowing it to report an additional 41 variants known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. “23andMe received the first FDA authorization for a
Devices
FDA says Universal Meditech has recalled all test products manufactured between 3/2021 and 11/2022 because the company is ceasing operations and is not able to continue fulfilling any post-market responsibilities for distributed products. Additionally, it says three products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio Ketone Test Strips
Devices
Becton Dickinson says there are several things the Microbiology Devices Panel of the Medical Devices Advisory Committee should consider at its 9/8 meeting to discuss topics related to in vitro diagnostic devices used in pandemic preparedness and response. The company comment letter makes these recommendations for the panel’s