Devices
Nipro Renal Soultions has recalled (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate, a dialysate concentrate for hemodialysis, due to the potential for the presence of visible foreign matter in the plastic bottles. Nipro Renal notified consignees on 4/11 through a “Urgent: Medical Device Recall” letter that instructed them to
Devices
FDA has cleared a BrightHeart 510(k) for the B-Right Views, an artificial intelligence (AI)-powered tool that automatically detects the standard views required for second- and third-trimester fetal heart ultrasound evaluations within routine anatomy scans. “The software supports fetal heart exams by confirming when all recommended views
Devices
FDA has cleared a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days of use in Type 1 diabetes patients. The device features an integrated inserter with a hidden needle designed for one-handed
Devices
FDA has approved GE HealthCare’s ultrasound imaging agent Optison 9 (perflutren protein-type a microspheres injectable suspension) for use in pediatric patients. The drug, which contains gas-filled microbubbles that enhance the visibility of heart chambers and walls during ultrasound imaging, was previously approved for adult use in 1997.
FDA Policy/General
FDA and HHS have launched a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” An FDA statement says the initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency in line with President Donald J. Trump’s Executive Order on “Unleashing
Devices
FDA has cleared a United Imaging 510(k) for its first interventional X-ray system, uAngio Aviva. The company says the “intuitively bionic ceiling-mounted system” uses intelligent robotics, voice control, vision and imaging to assist clinical staff. United Imaging describes the eight-axis robotic system as offering flexibility to
Devices
FDA has approved a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer screening. The prescription device is indicated for women aged 25–65 at average risk, according to the company. The at-home screening includes a collection kit and
Drugs
The FDA Office of Inspections and Investigations (OII) Ombudsman Program recommends that the agency explore developing a Stakeholder Education Hub, perhaps as a dedicated Web page that brings together existing educational resources organized around common concerns in a question-and-answer format. The recommendation is included in the program’s
Devices
FDA has given Orchestra BioMed the green light to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusion Balloon (Virtue SAB) for treating coronary in-stent restenosis. The agency approved a study design amendment allowing a head-to-head trial comparing Virtue SAB to the only FDA-
FDA Policy/General
FDA commissioner Michael Makary says the agency will expand the use of artificial intelligence (AI)-assisted scientific reviews across all Centers by 6/30. In a statement, he says the rollout follows the successful completion of a new generative AI pilot for scientific reviewers. “I was blown away by the
Devices
SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system for multiple indications. The modular, multi-arm system is designed with many advanced technology features, according to the company, including three to five modular robotic arms, an open-faced
Drugs
FDA says it will expand unannounced inspections at foreign manufacturing facilities that produce medical products, drugs, and food intended for U.S. consumers and patients. A 5/6 statement says the intent is to “ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic
Devices
FDA has cleared a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external bleeding. The device was previously indicated for temporary control of Class III and Class IV internal organ space bleeding, severely bleeding surgical wounds, mild and
Devices
A citizen petition from Harmed Americans for Reform in Medical-Device Safety is asking FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy (VATS) devices to perform the “hybrid convergent cardiac ablation” protocol in patients with isolated atrial fibrillation. It also urges
Devices
FDA has denied a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, an agency-designated breakthrough device intended for reducing the severity of bleeding in patients undergoing coronary artery bypass grafting surgery within two days of stopping the antiplatelet drug Brilinta (AstraZeneca’s ticagrelor). In its
Devices
FDA has cleared a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence (AI) model that uses deep learning for organs-at-risk (OAR) segmentation. The device “leverages the soft-tissue detail of MR [magnetic resonance] images to create precise organ contours of OAR during radiation therapy
Devices
FDA has approved Element Science’s PMA for the Jewel Patch Wearable Cardioverter Defibrillator. A company statement says the product “combines the principles of human-centered design with the latest advancements in machine learning.” The Jewel Patch is described as a novel, water-resistant wearable cardioverter defibrillator designed to detect
Devices
FDA has approved Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with severe aortic stenosis who show no symptoms. The approval extends the use of the platform, including the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves, to a broader patient population
Biologics
FDA commissioner Martin Makary says there will be no agency-wide reorganization. Interviewed by Jeremy Faust for an Inside Medicine Substack post, Makary said some staff asked for a reorganization and he rejected the proposal. “We are consolidating travel office, information technology, and some other things that make sense for
Devices
Attorneys Melissa Bianchi and Jodi Scott (Hogan Lovells) say medical device companies can learn from a recent FDA Warning Letter to Exer Labs citing a failure to obtain PMA or 510(k) clearance for its Exer Scan mobile AI-based screening tool. The letter also cited good manufacturing practice violations
Devices
Medtronic has submitted a PMA for its Hugo robotic-assisted surgery (RAS) system for a urologic indication. The submission is based on data from the company’s Expand URO clinical study, which met both primary safety and effectiveness endpoints. “The prospective, multi-center, single-arm IDE study included 137 patients
Devices
FDA has granted Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy, a pacemaker that uses conduction pacing to reduce blood pressure in patients with increased 10-year atherosclerotic cardiovascular disease risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive