Devices
FDA has issued a safety alert on Nuwellis’ AquaFlexFlow UF 500 Plus extracorporeal blood circuit, which is used with the Aquadex SmartFlow and FlexFlow Systems, because the device may trigger a “weight mismatch” alarm while in use. “If too many weight mismatch alarms occur, the Aquadex console will terminate therapy
Devices
FDA says the Hologic 3/13/2024 recall correction of BioZorb Markers was Class 1. An agency statement says the company updated the recall 10/25/2024 to remove all lots of the BioZorb markers. The single-use implantable radiographic marker is used to mark soft tissue, such as breast
Devices
FDA has issued an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide clamps. “If a solution set with an inverted slide clamp is loaded on an infusion pump, the medication may not be delivered and the patient’
Drugs
FDA has published the International Council for Harmonization’s draft Good Clinical Practice (GCP) E6(R3) guidance Annex 2. The document says Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralized elements, pragmatic elements, and/or real-world data. “Annex 2 is not meant to
Devices
A 5/6-5/22/2024 FDA inspection at the Becton Dickinson/CareFusion 303 facility in San Diego, CA, found multiple violations in the firm’s manufacturing of Pyxis Medication Management System medical devices. An 11/22/2024 Warning Letter details the specific violations as: * failure to establish and implement
Drugs
FDA has published a draft guidance, Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices, to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. The document says agency regulations do not include a definition of the term
Devices
FDA says the Boston Scientific 10/10/24 recall that updated instructions for using its POLARx and POLARx FIT cryoblation balloon catheters is Class 1. An agency statement says the company updated the user instructions for the catheters due to a higher than anticipated number of reports of esophageal injury,
Devices
FDA has cleared a Zimmer Biomet 510(k) for the OsseoFit Stemless Shoulder System for total shoulder replacement. The company says the device is designed to match the natural humeral (upper shoulder bone) anatomy to optimize anatomical fit while maximizing preservation of healthy bone. The anatomically designed anchor implants feature
Devices
FDA has approved a Johnson & Johnson MedTech PMA supplement for expanded indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist heart pumps and their use in specific pediatric patients with symptomatic acute decompensated heart failure and cardiogenic shock. Johnson & Johnson MedTech (formerly Abiomed) says
Devices
FDA has issued an early alert for an infusion pump issue from Fresenius Kabi USA. It is the first alert issued under a new CDRH communications pilot intended to enhance the medical device recall program. The early alert says the agency is aware that the company has issued a letter
Drugs
Four industry stakeholders are recommending changes to an FDA draft guidance on incorporating voluntary patient preference information over the total product lifecycle. AbbVie says it partners with patients, patient organizations, caregivers, and clinicians to ensure that individual experiences, perspectives, needs, and priorities are part of the clinical development process. The
Drugs
A Paragon Health Institute white paper presents guidelines that it says will protect the many benefits of artificial intelligence (AI) in healthcare without increasing risks to public health. “Patient safety is an overarching concern throughout,” the paper says, “as injury can be caused not only by faulty AI products but
Devices
Getinge/Maquet has issued a Class 1 recall (device correction) to inform users about important safety information for its VasoView HemoPro 2 Endoscopic Vessel Harvesting System (VH-4000 and VH-4001) due to complaints received for two failure modes experienced during use — a bent or detached heater wire, and silicone
Devices
FDA has granted MeMed a breakthrough device designation for its MeMed Severity test, intended for use in determining risk assessments in patients suspected of developing sepsis. The test is designed to “aid clinicians in rapid risk stratification and predicting disease progression, in conjunction with clinical assessments and other laboratory findings,
Devices
FDA has cleared Pentax Medical 510(k)s for new models of its Pentax Medical Video Colonoscope EC34-i20cL and Pentax Medical Video Upper GI Scope. The new slim models feature advanced imaging, enhanced maneuverability with adjustable stiffness, and advanced ergonomics to help improve experiences of the medical professionals working
Devices
FDA is updating a Baxter recall (device correction) of its MiniCap Extended Life PD Transfer Sets used in hemodialysis based on recent recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain
Devices
FDA has cleared an AngioDynamics 510(k) for the NanoKnife System for prostate tissue ablation. The clearance was based on data from the pivotal PRESERVE clinical study that evaluated the safety and effectiveness of the system in patients with intermediate-risk prostate cancer. The study met its primary effectiveness endpoint,
Devices
GE Healthcare has recalled (Class 1 instructions for use update) its Giraffe Omnibed Carestation and Incubator Carestation due to preliminary testing of newly manufactured devices that suggested higher levels of formaldehyde exposure for neonates in the first week of device use. The levels rapidly decrease after the first week of
Devices
Responding to concerns raised by Rep. Earl Blumenauer (D-OR), who has focused on animal welfare in medical product trials, FDA has advised Congress that in a 6/2023 inspection, the agency found “objectionable conditions” at an animal testing laboratory at Elon Musk’s Neuralink company. Reuters reports that the
Devices
FDA has granted Field Medical a breakthrough device designation its FieldForce Ablation System for treating sustained monomorphic scar-related ventricular tachycardia (VT). The device was also accepted into the agency’s Total Product Life Cycle Advisory Program (TAP), according to the company. Field Medical says the device is the first
Devices
FDA has added empty intravenous containers to the CDRH medical device shortages list and says the shortage is expected to last through 3/2025. An agency notice says after receiving alerts from healthcare providers and group purchasing organizations about potential shortages of empty IV bag containers, which are primarily used
Devices
FDA has cleared the Zimmer Biomet Persona SoluTion Porous Plasma Spray Femur, a total knee implant component that is an alternative for patients with sensitivities to bone cement and/or metal. A company statement says the Persona features a porous coating for cementless fixation and leverages a proprietary surface treatment