Devices
FDA has approved new labeling for several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy workflow to perform procedures. “The updated workflow indicates that direct imaging guidance, such as ultrasound, may be used as an alternative to fluoroscopy,” the company says, adding that reducing fluoroscopy
Devices
FDA has cleared an Imeka 510(k) for its Advanced Neuro Diagnostic Imaging (ANDI) quantitative imaging software, which is intended to generate a report for medical professionals on brain white matter as an adjunct to care. The report relies on artificial intelligence diffusion MRI-based white matter imaging to evaluate
Biologics
The Advanced Medical Technology Association (AdvaMed) says decentralized clinical trials can facilitate diversity in clinical trials. Commenting on an FDA draft guidance on decentralized clinical trials for drugs, biological products, or medical devices, AdvaMed says the document can facilitate recruitment of diverse populations in clinical trials and may help expedite
Devices
FDA has cleared a Becton, Dickinson 510(k) for the BD Respiratory Viral Panel for BD MAX System, a single molecular diagnostic combination test that BD says identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in about two hours. Previously, the test was
Devices
Baxter Healthcare has recalled its SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased false alarm reports of upstream occlusion after pump software upgrades. “False upstream occlusion alarms cause interrupted or delayed therapy and
Devices
FDA has cleared a Numares Health 510(k) for the Axinon LDL-p Test System, a test physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. The clearance includes the company’s core technology platform, the Axinon System, which incorporates diagnostic testing algorithms into nuclear magnetic
Devices
FDA says that it is expanding the medical device Total Product Life Cycle Advisory Program (TAP) pilot to include the Office of Neurological and Physical Medicine Devices beginning 10/1. The pilot, which began 1/1, was agreed to between FDA and industry as part of the reauthorization of the
Devices
Abbott says it has decided to stop selling its Trifecta heart valves due to the potential risk of early structural valve deterioration (SVD). Earlier this year, FDA issued a letter to healthcare providers about published literature suggesting a “higher cumulative incidence of early (five years or less) SVD for Trifecta
Devices
GE HealthCare has recalled its TruSignal SpO2 Sensors due to malfunction issues that may reduce defibrillation energy or expose patients to unintended voltage because of inaccurate readings. The skin-placed sensors are used to continuously monitor oxygen levels in the blood flowing through the arteries (arterial oxygen saturation or SpO2)
Devices
FDA has published a draft guidance, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, with recommendations for designing pivotal clinical studies of medical devices intended to treat opioid use disorder and used to support marketing submissions. The document’s recommendations apply to the design and development
Devices
Abiomed has recalled its Impella Left Sided Blood Pumps because the device’s “Instructions for Use (IFU)” do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR). “The IFU lacks guidance to clinicians on how to manage use of Impella in patients
Devices
FDA has cleared an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology. The software is intended to assist medical professionals without sonography experience in obtaining cardiac ultrasound images at the point of care in multiple settings. UltraSight says its software will “enable hospital staff to advance patient
Devices
An FDA update for healthcare providers has been issued to clarify that the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO) is to triage suspected findings of LVO based on the analysis of brain radiological exams. CDRH says it is working
Devices
FDA has cleared a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human urine. The Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for use with Carolina Liquid Chemistries Corp. immunofluorescence analyzer RYAN. It provides a preliminary test result,
Devices
Three SheppardMullin attorneys say FDA appears to be focusing enforcement on “intended use creep” that occurs when companies promote the capabilities of medical device software outside the scope of the intended use that was stated when the device was cleared. The attorneys’ online post discusses in detail a 6/21
Devices
Abbott is recalling its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles (air emboli) to be introduced into patients undergoing procedures. “Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart (indicated by ST elevation), fast or slow heartbeat
Devices
CDRH is announcing new steps to improve medical device sterilization. For one, the Center has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022). The new standard, Sterilization of Health Care Products — Low Temperature Vaporized Hydrogen Peroxide — Requirements for the Development,
Devices
FDA has cleared a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing Helicobacter pylori. The enzyme immunoassay is used to qualitatively detect H. pylori-specific antigens in fresh, frozen, or preserved human fecal specimens, according to the company. H. pylori infection is linked to several significant upper
Devices
FDA has cleared a Nesa Medtech 510(k) for its Fibroid Mapping Reviewer Application (FMRA), intended for use by physicians to generate a 3D model of the uterus from ultrasound images to assist in the accurate diagnosis and interventional procedure planning for patients with uterine fibroids. The FMRA technology allows
Devices
Datascope has recalled its Cardiosave Rescue IntraAortic Balloon Pumps because of the potential for unexpected shutdown. According to a recall notice, a pump shutdown may occur due to failures of tantalum capacitors in the power management board and solenoid board. This problem could lead to an unexpected interruption of therapy,
Devices
Former medical device regulatory affairs specialist Peter Stoll III has pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce. According to court documents, Stoll was responsible for making 510(k)
Devices
FDA has signed off on a Becton, Dickinson 510(k) that was filed over two years ago to update the firm’s troubled BD Alaris Infusion System that was the center of a cybersecurity threat and several recalls over the past few years. The agency clearance “enables both remediation and