Devices
FDA has approved Galderma’s Restylan Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the age of 21. The hyaluronic acid dermal filler was first approved in 2016 for mid-to-deep injection into the facial tissue for the correction of moderate to
Devices
FDA has cleared an NGMedical 510(k) for its 3D-manufactured titanium cervical interbody BEE cage implant. The device is designed to reduce the risk of subsidence while allowing fusion, the company says. Its honeycomb structure allows for bony ingrowth and it demonstrates the reduced use of titanium to minimize
Devices
FDA has denied a Public Citizen 7/7/15 petition asking that the agency withdraw its premarket approval of Genzyme’s Seprafilm and also start a mandatory recall of all remaining unused Seprafilm devices. The agency response says that while it denied the petition, it has requested additional Warnings and
Devices
University of Michigan associate professor Kevin Fu has been named to a one-year term as an expert-in-residence with CDRH as acting director of medical device cybersecurity. The university says Fu’s position is within the Center’s Office of Strategic Partnership and Technology Innovation. It says he
Devices
FDA says a Boston Scientific 12/2/20 recall of 19,919 EMBLEM S-ICD subcutaneous electrodes is Class 1. A recall notice says the electrodes are part of the Boston Scientific S-ICD implantable cardioverter defibrillator system. The company recalled the electrodes due to an increased risk of fractures
Devices
FDA has cleared an Inovytec 510(k) to market its Ventway Sparrow ventilators in the U.S. The company says the transport and emergency ventilators weigh about 2.2 pounds and allow for both invasive and noninvasive ventilation for patients weighing above 5 kg. “A built-in turbine removes dependency
Devices
FDA has cleared a Soliton 510(k) for its Rapid Acoustic Pulse (RAP) device and technology for the short-term improvement in the appearance of cellulite. The company says that its rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite in
Devices
Wahl Clipper Corp. has recalled all Deluxe Heat Therapy Massagers, Model 4212, due to overheating concerns. A recall notice says users should discontinue use immediately, adding that the connection between the massager and heat attachment can overheat causing smoke or spark, which may pose a fire hazard. To view the
Devices
FDA has approved a Medtronic PMA for the DiamondTemp Ablation (DTA) system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) who have been unresponsive to drug therapy. The device is a temperature-controlled open-irrigated radiofrequency (RF) ablation system designed to deliver RF energy during ablations, Medtronic says,
Devices
FDA has classified as Class 1 a Penumbra recall of its Jet 7 Xtra Flex catheter due to its potentially becoming susceptible to distal tip damage during use. As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the Jet 7 Xtra Flex catheter
Devices
FDA has cleared a Perspectum 510(k) for Hepatica, a precision oncology decision support tool for liver cancer. The device a quantitative multiparametric MRI to provide a liver health assessment based on artificial intelligence (AI)-driven liver segmentation together with proprietary biomarkers for hepatic fibro-inflammation and fat, according to
Devices
FDA has updated an immediately-in-effect guidance, Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to help expand the availability of coagulation systems for measurement of whole blood viscoelastic properties that are used to assess hemostasis for the
Devices
Faced with ongoing safety concerns about hand sanitizers coming from Mexico, FDA has decided to place all alcohol-based hand sanitizers from the country on import alert to intercept them until the agency is able to review their safety. “Over the course of the ongoing pandemic, the agency has seen
Devices
FDA has released the FDA-483 with eight inspection observations issued following a 3/2-4/6/20 inspection at CareFusion 303, a San Diego, CA, medical device manufacturer. The inspection observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately establish procedures for receiving,
Devices
CDRH says it has published three final guidance documents implementing the voluntary Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The Center’s 2020 ASCA annual report identifies the three documents as a program guidance, basic safety and essential performance standards-specific guidance, and biocompatibility standards-specific guidance. “The ASCA
Devices
The Advanced Medical Technology (AdvaMed) Association has reiterated to FDA that early stakeholder engagement is critically important when the agency is considering medical device safety communications about currently marketed devices. In comments submitted to the agency regarding an 11/17/2020 public meeting on “Communications About the Safety of Medical
Devices
FDA has cleared a Theranica 510(k) for its Nerivio therapeutic device for an expanded indication for acute treatment of episodic or chronic migraine in patients aged 12 years and older. The company says that about 10% of all school age children and up to 28% of teens between the
Devices
FDA has approved a Boston Scientific PMA for its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System. The approval covers conditional use in a magnetic resonance imaging environment. The Bluetooth-enabled, rechargeable and non-rechargeable device includes an implantable pulse generator that powers the Cartesia Directional Leads to provide
Devices
The Medical Device Innovation Consortium (MDIC), which includes FDA as a member, will receive public comments until 2/22 on its External Evidence Methods Framework. An MDIC statement says the document is intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Specifically, the
Devices
FDA has cleared a Canon Medical Systems 510(k) for the Aquilion Exceed LB CT system, which is intended to provide clinicians the opportunity to see more during radiation therapy planning to improve accuracy, precision and speed. The device features a large bore opening (90 cm), edge-to-edge extended
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Multix Impact VA20, a new version of the established floor-mounted parent DR system. Both devices feature intuitive operating systems, versatile wireless detectors, motorized tube heads, and
Devices
FDA has cleared an Eitan Medical 510(k) for its upgraded Sapphire infusion pump system and software Rev15, which includes pump, administration sets and accessories. The device is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition, lipids, IV medication, perineural