Devices
FDA has cleared an Oticon Medical 510(k) for its active transcutaneous bone conduction hearing system, the Sentio System. The device includes the Sentio 1 Mini, an external sound processor, and Sentio Ti Implant, which is placed under the skin. Its design and slim profile make it 26% lighter than
Devices
FDA has published draft guidances on dental composite resins and curing lights. The first, Dental Composite Resin Devices—Premarket Notification (510(k)) Submissions, has draft recommendations for dental composite resin 510(k)s. The document says the device is intended to fill and restore defects or carious lesions in teeth.
Devices
Hamilton Medical is recalling (Class 1) its software for the Hamilton-C6 Medical Ventilator because the ventilator may fail to restart ventilation if it enters sensor fail mode after open suction is performed and the patient is reconnected. The agency says the recall is a device correction and not a
Devices
FDA says Baxter is recalling its Life 2000 Ventilators with a specific product code due to potential battery charger dongle damage. An agency online post says the company has received reports that the devices are not properly charging when there is damage to the battery charger dongle. “Baxter has received
Devices
FDA has published a guidance, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, with recommendations for the design of pivotal studies for devices intended to treat opioid use disorder (OUD) and used to support marketing submissions. The document says the recommendations apply to the design and
Devices
FDA has given 510(k) clearance to ImmersiveTouch’s ImmersiveAR virtual reality and augmented reality imaging system for clinical use in operating rooms. A company statement says the system allows surgeons to visualize and interact with 3D virtual surgical plans created by ImmersiveTouch or other virtual surgical planning providers, overlaid
Devices
AdvaMedDx is calling for changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic devices for immediate public health response in the absence of a declaration under Section 564. The trade group says the scope of the guidance should include all in vitro diagnostic manufacturers
Devices
FDA has approved a Cordis PMA for its Mynx Control Venous Vascular Closure Device (VCD), for cardiac ablation procedures with access sites from 6F-12F. The device features the company’s Grip Technology and has been shown to resorb three times faster than collagen-based sealants, the company says. “In
Devices
FDA is alerting healthcare providers and facilities to stop using Medtronic NIM (neural integrity monitor) Contact and Standard EMG (electromyogram) Reinforced Endotracheal Tubes due to a company 7/9 urgent recall. An FDA notice says the tubes are used during surgery to provide an airway for patient ventilation and to
Devices
Inspire Medical Systems is recalling (Class 1) its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect, which can cause system malfunctions and an electrical leakage in the sensing circuit. “As a result, patients may need revision surgery to replace the IPG and restore therapy,” a
Devices
Philips North America is recalling (Class 1) its Sense XL Torso (1.5T and 3.0T) MRI coils to update use instructions due to a potential issue where the coil heats up during MRI scans, possibly leading to thermal injury. “The use of affected product may cause serious adverse health
Devices
Medical device maker Magellan Diagnostics (Billerica, MA) has pleaded guilty in federal court in Boston to criminal charges arising from its concealment of a device malfunction that produced inaccurately low lead test results for tens of thousands of patients. The company pleaded guilty to two counts of introducing a misbranded
Biologics
Several law firms have posted analyses of the Supreme Court Loper Bright decision that overturned the 40-year precedent of deference to agency interpretations of ambiguous laws first announced in Chevron. A Sidley Food, Drug, and Medical Device Update says the Supreme Court decision to overturn Chevron deference to agencies
Drugs
Although FDA says that compliance with its new Diversity Action Plan (DAP) initiative outlined in a recent draft guidance won’t take effect until 180 days after the future final guidance is published, drug and medical device sponsors should start planning how they will comply with the significant new requirements.
Devices
FDA says CDRH will continue to expand its Total Product Life Cycle Advisory Program (TAP) to include medical devices reviewed in the Office of Radiological Health and the Division of Ophthalmic Devices in the fall of 2024 and the Office of Orthopedic Devices in 2025. A TAP pilot was launched
Drugs
FDA has published a draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers, to respond to common questions firms may have when voluntarily addressing misinformation about or related to their approved or cleared medical products. The document describes existing avenues for communications by firms and also
Drugs
FDA has published a draft guidance, Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products, describing the agency’s recommendations related to the device design outputs that are essential for establishing and assessing drug delivery performance in medical devices and combination products. The document includes recommendations
Devices
Philips Respironics has issued updated instructions for three of its BiPAP ventilators due to interruptions and/or loss of therapy. An FDA notice says the recall does not involve removing the devices from where they are used or sold. It is considered a Class 1 recall, the notice says, because
Drugs
Public Citizen’s Coalition for Sensible Safeguards says the Supreme Court's 6/28 decision that overturned a 40-year-old legal precedent to gut the so-called “Chevron deference” will harm the public. “The court today, once again, sided with big corporations trying to weaken agencies’ ability to
Devices
Abbott Medical is recalling (Class 1) its HeartMate System Monitor due to “atypical behavior of the System Monitor screen.” The agency notes that the recall is considered a device correction and is not a market withdrawal. The screen issues include screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text
Devices
FDA has granted a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System, which the agency says is the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for
Devices
FDA says CDRH is partnering with the Bill and Melinda Gates Foundation to create new analytical methods to help develop breath-based diagnostic devices for disease detection in underserved populations. In an online post, CDRH director Jeffrey Shuren and Office of Science and Engineering Laboratories director Ed Margerrison say the