Devices
FDA has approved an Intersect Ent PMA for its Straight Delivery System for use in placing the company’s Propel Mini steroid-releasing implant in the ethmoid sinus. The company says Propel is intended to help maintain the sinus opening while delivering mometasone furoate directly where it is needed, improving
Devices
FDA has cleared a MiRus 510(k) for the Cygnus Anterior Cervical Plate System. The device features an “I-beam design“ and the metal alloy used in the plate allows for a smaller footprint than other marketed devices, the company says. Its narrower profile will lead to “less retraction and
Devices
FDA has published a guidance, Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions, with recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. The document says the devices are intended to provide luminal patency of the biliary tree for palliation of malignant strictures.
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Expandable Spacer System. The device’s 8mm-10mm new widths more than double its current spinal options to accommodate a wider range of patients and their unique pathologies, the company says. It also features the company’s proprietary Osseo-
Devices
FDA says it is taking “significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)” by asking Allergan to recall specific models of its textured breast implants from the U.S. market. An agency statement says the company has indicated it is moving forward with
Devices
Maquet/Datascope is recalling all Intra-Aortic Balloon Pumps (IABP) due to reports of the IABP batteries failing to hold a charge, stopping unexpectedly, and having a shortened run-time which may cause the device to stop working when being operated by battery only. The recall is being conducted to
Devices
Medtronic has submitted a PMA for non-adjunctive labeling for its Guardian Sensor 3, which is part of the MiniMed 670G insulin delivery system. If the agency approves a sensor with non-adjunctive labeling, it means that a sensor is accurate enough to be used to calculate an insulin dose
Devices
Becton Dickinson has recalled its Alaris Pump Module Model 8100 bezel assembly because of a defect that could result in free flow, over-infusion, under-infusion, or interruption of infusion. A recall notice says that the bezel posts may become cracked and separated which could lead to inaccurate fluid delivery
Devices
FDA has cleared an Erchonia 510(k) to market FX low-level laser for the temporary relief of chronic, nociceptive musculoskeletal pain. Clearance was based on data from placebo-controlled clinical trials with 255 patients, which showed that those treated with the laser documented a 49% average pain reduction post
Devices
Becton Dickinson has recalled its Alaris Infusion Sets due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a “running status.” A recall notice says that a silicone segment of the affected device has non-
Devices
Pear Therapeutics is asking FDA for marketing authorization for its Somryst, described as a prescription digital therapeutic intended for use in treating adults with chronic insomnia and depression. The company says Somryst is intended to provide neurobehavioral interventions, specifically cognitive behavioral therapy for insomnia and sleep restriction driven by algorithms
Devices
AdvaMed says an FDA draft guidance on review and update of device establishment inspection processes and standards “should be risk-based and consider the participation of the subject company in international device audit programs.” The trade association’s 5/28 comment letter also recommends that the draft guidance include criteria
Devices
Teleflex has recalled its Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column due to complaints about cracks being observed, prior to use, on the swivel wye adaptors. “Cracks in the adaptor may cause breathing distress because the gas may leak and not reach the patient,” a recall
Devices
FDA has cleared an Integrated Endoscopy 510(k) for Nuvis Single-Use Arthroscope. The battery-operated arthroscope is designed to provide high definition visualization with its proprietary optical design, “while directly addressing key safety and sterility issues associated with traditional, reusable arthroscopes,” the company says. The single-use aspect provides
Devices
FDA has issued a safety alert about potential complications in patients implanted with both programmable cerebrospinal fluid (CSF) shunt systems and some hearing implants that contain magnets, such as cochlear implants, bone conduction hearing devices, or middle ear hearing devices. “Magnetic interactions between these devices may occur when implanted in
Devices
Stakeholders say they support an FDA proposal to reclassify internal surgical staplers as Class 2 devices and to implement uniform special controls as part of the reclassification. In a letter commenting on an agency draft guidance, Medtronic says that conducting additional bench and animal testing on devices that have been
Devices
FDA has announced two “innovation challenges” to encourage the development of new approaches to device sterilization. They are: Challenge 1: To identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide. Challenge 2: To develop strategies or technologies to reduce emissions to
Devices
FDA has cleared a LivaNova 510(k) for its LifeSPARC system, a new circulatory support pump and controller, intended for use in providing temporary support for emergent rescue patients in a variety of settings. The device includes four specialized and ready-to-deploy kits, each designed to support diverse cannulation
Devices
FDA has approved an Abbott PMA for its fourth-generation MitraClip, a heart valve repair device to treat mitral regurgitation. The latest version includes an expanded range of clip sizes, an alternative leaflet grasping feature and real-time procedure assessment to offer doctors further options when treating mitral valve disease,
Devices
FDA has issued a Warning Letter to Abington Memorial Hospital’s institutional review board after a bioresearch monitoring inspection found violations. For example, FDA said the IRB failed to review proposed research at convened meetings at which a majority of members of the IRB are present. The IRB was also
Devices
GE Healthcare has recalled its Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle. If an infant comes in contact with
Devices
FDA scientists have developed and qualified under its Medical Device Development Tools (MDDT) program a “Tissue Mimicking Material (TMM) for Preclinical Acoustic Performance Characterization Of High Intensity Therapeutic Ultrasound (HITU) Devices. ” HITU developers can use the qualified tool to test device safety and effects in a preclinical setting using “phantoms”