Devices
Zyno Medical has recalled certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps because they were released to customers with incorrect software versions that had not undergone required verification and validation testing. “As a result, these pumps can experience unexpected performance problems, including issues with essential functions
Devices
Nipro has recalled (Class 1) its MedicaLyte liquid bicarbonate concentrate after receiving reports about “visual irregularities in some product jugs,” according to a recall notice. “Returned units were sent to a third-party laboratory for analysis, where bacterial and fungal particles were identified,” it says, adding that risks associated with
Devices
FDA says the Medtronic 5/2025 recall of specific Newport HT70 and HT70 Plus ventilators and certain related Newport service parts is Class 1. An agency notice says the company was advising customers to discontinue clinical use of the affected devices. Investigation into customer complaints identified two separate capacitors on
Devices
FDA has cleared a Viz.ai 510(k) for the Viz Subdural Plus, which the company describes as the “first and only comprehensive solution for quantifying the size of collections like subdural hemorrhages (SDH) in the subdural space on non-contrast computed tomography (NCCT) images." The device is designed
Devices
AI researchers in the U.S. and Canada are calling on FDA to foster an agile, transparent, and ethics-driven artificial intelligence (AI) oversight system that can balance innovation with patient safety, ensuring that AI-driven medical technologies enhance, rather than compromise, healthcare outcomes. Writing in the open-source PLOS
Devices
Baxter has recalled (Class 1 device correction) its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the device’s “standby mode” feature, or if the device is powered off with the set loaded. “Keeping the administration set loaded in the pump for
Devices
FDA says a Draeger 3/3 recall of VentStar Flex and Anesthesia Circuit kits is Class 1. An FDA notice says the company updated the use instructions on the breathing circuits after receiving reports that cracks may form in the hose during use. The cracks may cause leaks, the notice
Devices
A 1/6-1/9 FDA inspection at DFI Co., Ltd. in Gimhae, Gyeongsangnam, Korea, found Quality System Regulation violations in the firm’s manufacturing of Cybow reagent strips for urinalysis. A 5/6 Warning Letter says the specific violations were: * failure to establish and maintain adequate procedures for receiving,
Devices
FDA is announcing three Class 1 recalls (device corrections) by Smiths Medical related to certain CADD [computerized ambulatory delivery device]-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps. Smiths Medical has notified affected users about the following corrections: * Infusion Pump False Occlusion Alarm: Under certain conditions, a
Devices
FDA has released a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers.” The document provides information on the most frequently asked questions regarding the transfer or sale of a 510(k) clearance from one application holder to another. It discusses topics related to a
Devices
A roundtable of experts convened by the Government Accountability Office (GAO) says HHS should have a coordinated national approach to diagnostic testing for pandemic threats. A GAO report outlines steps FDA and other HHS units can take to support such an approach. While the roundtable suggested nearly 100 actions HHS
Devices
Having failed to appeal a federal court decision vacating the laboratory-developed test (LDT) rule it proposed, FDA has accepted that it does not have a role in regulating such tests. That’s the view of attorneys Steven Gonzalez and Allyson Mullen (both Hyman, Phelps & McNamara) in a post
Devices
FDA has given de novo authorization to Clarity’s Clarity Breast, described as a “novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram.” A company statement says most risk assessment models rely heavily on age and family history to predict risk.
Devices
FDA has cleared a Hyperfine 510(k) for its next-generation AI-powered portable MRI system for the brain, the Swoop system. The clearance includes a new portable MRI scanner powered by the proprietary Optive AI software that helps to deliver high image quality and functionality, according to the company.
Devices
FDA has granted BiVACOR a breakthrough device designation for its titanium Total Artificial Heart (TAH). The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including a left ventricular assist device, are not viable, according to
Devices
An 11/4-11/7/2024 FDA inspection at DRG Instruments GmbH in Marburg, Germany, found multiple violations in the firm’s manufacturing of several in vitro diagnostic devices. A just-released 3/31 Warning Letter says two of the firm’s diagnostic devices are adulterated because DRG does not
Devices
FDA has published one final and one draft guidance on aspects of its medical device Q-Submission program. The final guidance Request for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program gives an overview of the mechanisms available to submitters through which they can request interactions with
Devices
A 1/20-1/24 FDA inspection at Sedecal S.A. in Madrid, Spain, found Quality System Regulation violations in the firm’s manufacturing of mobile digital radiography systems. A 5/5 Warning Letter says the specific violations were: * failure to adequately establish and maintain procedures for implementing corrective and
Devices
FDA has issued a Warning Letter to Kabe Labortechnik, the North Rhine-Westphaia, Germany-based manufacturer of the RAM Scientific SAFE-T-FILL Capillary Collection System tubes distributed by ASP Global that are linked to a safety alert issued last month on reports of falsely elevated (false positive) results that
Devices
FDA has given 510(k) clearance to the Olympus EZ1500 series endoscopes that the company says feature extended depth of field (EDOF) technology. A company statement says the series’ gastroscope and colonoscope “represent Olympus’ most advanced imaging and latest innovation as part of the EVIS X1 endoscopy system. By allowing
Devices
BD has recalled (Class 1 device correction) its Esophagogastric Balloon Tamponade Tubes to update the device’s instructions for use due to difficulties in removing plastic plugs from its rubber lumen to inflate the balloons. In some cases, the devices may become damaged during removal of the plastic plugs in
Devices
Centerline Biomedical has recalled (Class 1) its Intra-Operative Positioning System’s (IOPS) Guidewire 2, a sensorized wire used to navigate through a patient’s vasculature to help accurately place a catheter. A recall notice says that the company has determined that the coating on the guidewires for lot# 2404-