Devices
FDA has cleared a CoreLink 510(k) for the F3D Corpectomy VBR System, a vertebral body replacement that is intended to surgically replace one or more damaged vertebral bodies in the cervical and thoracolumbar spine. The implant is designed to provide support while fusion occurs, the company says. The system
Devices
FDA says it has extended to 8/18 the deadline for comments on a discussion paper on “Conveying Materials Information about Medical Devices to Patients and Healthcare Providers.” An agency notice (includes a link to the paper) says the document is intended to help FDA gather feedback from the public
Devices
FDA has approved a Medtronic PMA supplement for expanded approval for its Arctic Front Cardiac Cryoablation Catheters to include treating recurrent symptomatic paroxysmal atrial fibrillation (episodes that last less than seven continuous days) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. The expanded indication
Devices
FDA has cleared a Masimo 510(k) for the Radius T, a wearable, wireless thermometer that measures body temperature continuously. The device is described by Masimo as being compatible with both the Root Patient Monitoring and Connectivity Hub and the Rad-97 patient monitor for use in the hospital, as
Devices
FDA has granted Spinologics a breakthrough device designation for its MIScoli system, a vertebral body tethering device to treat scoliosis in young adolescents. The device is being developed as an alternative to spine fusion when adolescents need a surgical intervention to correct a curvature of the spine. The company says
Devices
Smiths Medical has begun a Class 1 recall of specific models and lots of Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes that may have skewed odd number line graduation markings on their syringe barrels. Markings skewed about 20 degrees upward have been identified, a recall notice says. “As a
Devices
FDA has issued a draft guidance, Remanufacturing of Medical Devices, to help clarify whether activities performed on devices are likely “remanufacturing.” The document says such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. The draft also includes recommendations for information that should
Devices
FDA says Philips issued a 6/14 recall notification to mitigate potential health risks related to the sound abatement foam in its bi-level positive airway pressure, continuous positive airway pressure, and mechanical ventilator devices. An agency notice says company testing determined there are possible risks to users related to
Devices
FDA says a Medtronic Vascular 5/4 recall of angiographic guidewire components is Class 1. The company says the recall was issued because the components were to be shipped to a third-party for further processing into kits and sterilization but instead were shipped directly to customers. Medtronic says some
Devices
FDA has cleared a NeuraLace Medical 510(k) for its Axon Therapy for stimulating peripheral nerves to provide chronic nerve pain relief. The device works by delivering focused magnetic pulses which activate the damaged peripheral nerve axons that are required to provide relief from chronic nerve pain. Its low frequency
Devices
CDRH has released for comment a discussion paper, “Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities,” seeking input from groups and individuals outside FDA on the shared responsibility. Four areas identified in the paper are privileged access, identification of cybersecurity vulnerabilities and incidents, prevention and mitigation
Devices
Several Republican members of Congress, who are part of the Doctors Caucus on the Hill, are urging FDA to prioritize tests measuring the presence of T cell-mediated immunity to Covid-19. Tests measuring T cells could provide better detection of immunity in those naturally infected and could also be
Devices
FDA has classified as Class 1 a recall of the Alaris Infusion Pump Module Model 8100 Bezel, purchased or installed by Infusion Pump Repair. Infusion Pump Repair is recalling the affected products and devices because the bezel components may crack or separate, leading to inaccurate delivery of fluids to patients.
Devices
Sen. Rand Paul’s Verified Innovative Testing in American Laboratories Act of 2021 (the VITAL Act of 2021) will lead to a better conversation on the regulation of laboratory-developed tests (LDTs) than could come from FDA actions. That’s the opinion of attorney Jeffrey Shapiro (Hyman, Phelps & McNamara)
Devices
Two facility inspections of Innova Medical Group that ended 4/9 have led to a 6/10 Warning Letter because the firm is marketing its SARS-CoV-2 Antigen Rapid Qualitative Test without marketing approval, clearance, or authorization from FDA. The agency also found that clinical data submitted in Innova’
Devices
FDA has cleared a Nuvo Group 510(k) for its InVu remote pregnancy monitoring platform that adds a new module enabling remote monitoring of uterine activity (UA). The company says the device uses only external sensors, allowing it to be used without any invasive component or the need for an
Devices
FDA has approved a change to the age indication for Avita Medical’s Recell system in combination with meshed autografting for treating all sizes of acute full-thickness thermal burn wounds in both pediatric and adult patients. The expanded indication removes the prior limitation of use in patients under age
Devices
FDA says the public should stop using the Innova SARS-CoV-2 antigen rapid qualitative test for diagnostic use due to the agency’s “significant concerns that the performance of the test has not been adequately established, presenting a risk to health.” An agency notice says that labeling distributed with
Devices
FDA has approved Medtronic’s Vanta recharge-free implantable neurostimulator that is said to have a device life that can be optimized up to 11 years. The company says that at comparable settings, the Vanta device offers nearly twice the device life of competitive primary cell devices. Medtronic says the
Devices
The Neurological Devices Panel of the FDA Medical Devices Advisory Committee met 6/3-4 to discuss and make recommendations related to the classification of six unclassified, preamendments device types. A meeting summary lists the items discussed as classification of: * vapocoolant devices; * acupressure devices; * electro-acupuncture stimulators; * attention task performance
Devices
FDA has cleared a CyMedica Orthopedics 510(k) for its IntelliHab for managing knee osteoarthritis pain. The device delivers neuromodulation strengthening therapy to treat pain associated with osteoarthritis. The individualized muscle stimulation is intended to reduce muscle weakness, “while keeping patients proactive in therapy through an intuitive app-driven interface,
Drugs
FDA says it has decided not to accept a Verily Life Sciences 1/25 Letter of Intent for the Virtual Motor Exam for Parkinson’s disease, Part 3 Estimator, as measured by the Verily Study Watch. An agency determination letter says the letter proposed assessment of motor symptom severity in