Devices
FDA has cleared an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times — covering the stomach, small bowel, and colon — as an aid in diagnosing gastrointestinal motility disorders (gastroparesis and slow transit constipation). “By measuring regional and whole gut
Devices
FDA has posted a draft guidance entitled “Unique Device Identifier (UDI) Requirements for Combination Products.” The document discusses how the agency’s UDI requirements apply to combination products with device constituent parts. It also outlines requirements, recommendations, and best practices for UDI labeling and submission of information to the Global
Drugs
FDA has published a guidance, Conducting Remote Regulatory Assessments—Questions and Answers, to help enhance the industry’s understanding of such assessments, thus facilitating the process for FDA conducting the assessments. The document says the term Remote Regulatory Assessment (RRA) is used to describe a category of activities for which
Devices
FDA has released a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document applies to devices with cybersecurity considerations, including but not limited to those that have a device software function or that contain software (including firmware) or programmable logic, and it
Devices
FDA has approved an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery stenosis. The device is described as a novel mesh-covered stent designed to improve patient safety through sustained embolic protection. The device’s approval is supported by data from the company’s C-
Devices
Cook Medical has recalled (Class 1) its Beacon Tip 5.0 Fr Angiographic Catheter because it may experience tip separation. The issue was identified through field complaints, with users reporting tip separation occurring both prior to and during patient contact, a recall notice says. “If an affected product is used,
Devices
FDA has alerted healthcare providers to agency import alerts for certain medical devices manufactured by Olympus Medical Systems and its subsidiaries. An online notice says the alerts apply to specific models of the firm’s uteroenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. “Despite extensive and ongoing efforts to address compliance
Devices
FDA has issued a safety alert on Medtronic subsidiary Given Imaging and certain Bravo CF Capsule delivery devices, which are designed to place and attach a pH monitoring capsule to the esophagus to assist a physician in diagnosing clinical gastroesophageal reflux. The alert says Medtronic has told customers that the
Devices
A 1/20-1/23 FDA inspection at Aju Pharm Co. Ltd. in Seongnam-Si, Gyeonggi, South Korea, found Quality System (QS) and Medical Device Reporting (MDR) violations in the company’s manufacturing of the Class 2 Fixone Hybrid Knotless Anchor and the Class 2 Fixone Biocomposite Anchor. A just-
Devices
GE HealthCare is recalling (Class 1 device correction) certain Carestation anesthesia devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode. “If this issue occurs, it will be apparent to the user through observation and multiple alarms,” a recall notice says.
Devices
FDA has cleared a DeepEcho 510(k) for its artificial intelligence (AI)-based fetal ultrasound analysis platform. The device “leverages advanced deep learning algorithms to automate real-time identification of fetal ultrasound views, providing healthcare professionals with enhanced diagnostic accuracy and efficiency,” the company says. The device’s technology is
Devices
The issuance by FDA of two Warning Letters to manufacturers of diagnostic products labeled for research use only (RUO) within three months may be a coincidence or may signal a new FDA enforcement emphasis. That’s the view of attorneys Dominick DiSabatino and Audrey Mercer (SheppardMullin) in their firm’s
Devices
A 10/29-12/20/2024 inspection at Reset Technology Corp. in Irving, TX, identified multiple violations in the firm’s manufacturing of the ResetSmile partial denture device and ResetSmile impression kit device. A 6/9 Warning Letter says specific Quality System Regulation violations were: * failure to ensure that when
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