Devices
The Department of Justice says global medical technology company Bioventus is paying over $3.6 million to resolve allegations that it violated the False Claims Act by submitting improperly completed certificates of medical necessity for medically unnecessary devices from 10/1/12 through 12/31/18. A department statement says
Devices
FDA has cleared Neurolief’s Relivion system, the first non-invasive, multi-channel brain neuromodulation system for at-home treatment of acute migraine. The company says that Relivion, worn as a headset, demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within two hours after treatment. The agency’
Devices
Medtronic is recalling (Class 1) its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting after the pump was stopped. Such delays or failures to start or restart have occurred during pre-implant testing, during the
Devices
Empirical Spine says it will submit a rolling PMA for its LimiFlex Paraspinous Tension Band for treating patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The submission will be based on data from a pivotal trial comparing outcomes from patients who receive either LimiFlex or transforaminal lumbar interbody fusion
Devices
Medtronic has recalled all unused Valiant Navion thoracic stent grafts and informed physicians to immediately stop using the device until further notice due to reports from the Valiant Evo Global Clinical Trial indicating that three were observed to have stent fractures, two of which have confirmed Type IIIb endoleaks, and
Devices
FDA has granted a de novo marketing authorization to Q30 Sports Science for its Q-Collar, a device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in protecting the brain from the effects associated with repetitive sub-concussive head
Devices
CDRH Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel says that as of 2/17 FDA had authorized 331 tests and sample collection devices, including 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. Speaking at the 43rd CDRH virtual town hall
Devices
Participants in a 2/24 DTx West virtual panel said a growing number of digital health companies “are finding themselves in a gray area of enforcement discretion, a term FDA uses for lower-risk products that meet the definition of a medical device but do not require regulatory submission, review,
Drugs
The Sedgwick Brand Protection State of the Nation 2021 report predicts that by mid- to late-2021 FDA will start revoking medical device emergency use authorizations, reverting to unapproved status devices that were not approved by regular means. The report cautions that legal protections currently offered to manufacturers and distributors
Devices
FDA has granted Dascena a breakthrough device designation for its GI Bleed Risk Alert System (Gibras), a cloud-based software application that uses a machine learning algorithm to analyze patient electronic health record data to aid in the early prediction of gastrointestinal bleeding (GIB) in adult patients in a hospital
Drugs
FDA has issued a updated guidance for currently authorized Covid-19 vaccines that could be modified with limited data to address emerging variants. In announcing the guidance, FDA acting commissioner Janet Woodcock said the document will allow FDA and developers to pivot as the virus adapts. “At this time, available
Devices
FDA has cleared a Piccolo Medical 510(k) for its SmartPICC System that is intended to give healthcare providers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without relying on x-ray or fluoroscopy confirmation of correct catheter placement. The company says that
Devices
FDA has issued a safety alert on the limitations of pulse oximeters. “While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings,” the agency says. It adds: “Patients with conditions such as Covid-19 should not rely solely on
Devices
FDA has cleared an FX Shoulder 510(k) for the Easytech Stemless Anatomic, a shoulder prosthesis featuring primary peripheral fixation. The device’s design and Easytech Anchor base allows it to fit peripherally just inside the cortical bone where bone quality is optimal for fixation, the company says. It is
Devices
FDA has approved Additive Orthopaedics’ Patient-Specific Talus Spacer, a first in the world and first of its kind 3D-printed talus implant for humanitarian use to treat avascular necrosis (AVN) of the ankle joint. An agency statement says the implant “provides a joint-sparing alternative to other surgical interventions
Devices
AdvaMed says that changes in testing requirements for electromagnetic compatibility (EMC) of medical devices should be made with advance notice and appropriate phase-in periods. In comments on an FDA draft guidance, Electromagnetic Compatibility of Medical Devices, AdvaMed says recent changes in testing requirements for in vitro diagnostic (IVD) instrumentation
Devices
FDA has approved expanded MRI labeling for Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads. The updated MRI labeling allows for a wider range of MRI scan parameters and shorter wait time between MRI scans, the company says, adding that it applies
Devices
FDA’s Circulatory System Devices Panel has voted not to recommend approval of BD’s Lutonix drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter for treating below-the-knee lesions in patients with critical limb ischemia. Panel members voted 15 to 2 in support of the device’s safety, 2
Devices
Three SheppardMullins attorneys say a recent Federal Trade Commission (FTC) settlement highlights the importance of accurately describing how information is collected, used, and shared in digital health apps. In an online FDA Law Update Blog post, the attorneys say FTC settled with Flo Health, Inc., a fertility-tracking app, based
Devices
A 2/10 CDRH virtual town hall answered questions about the development and approval of SARS-C0V-2 (Covid-19) diagnostic tests. Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel and associate director Toby Lowe fielded questions on issues including: * transferring ownership of an emergency use authorization;
Devices
Attorney Matthew Decker (Duane Morris) says a 1/12 FDA action plan on the regulation of artificial intelligence and machine learning (AI/ML)-based software as a medical device (SaMD) outlines five primary goals and commitments to advance the agency’s interest in facilitating the innovation of SaMD while developing
Devices
FDA has approved an Axonics Modulation Technologies PMA for its third-generation implantable neurostimulator. The company says the third-generation updates the software in the neurostimulator and the functionality of the patient remote control.