Devices
FDA has posted a final guidance entitled “Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency.” The document is intended to help with the availability of devices for use in transporting certain clinical specimens, including transport media that can be used for certain clinical specimens
Devices
Verathon has recalled the GlideScope Core One TouchSmart Cable, which is part of its Video Laryngoscopy System, due to the potential for temporary or complete loss of image when used with Core 10 and Core 15 video monitors. “If there is an interruption in the video signal during use, this
Devices
FDA has cleared an Ambu 510(k) for its Ambu aScope Duodeno, a single-use duodenoscope. The device features a reusable processor unit, Ambu aBox Duodeno. Duodenoscopes are used for visual examinations of the duodenum and for diagnosing and treating conditions like gallstones, pancreatitis, tumors or cancer in the bile
Devices
A 7/7 CDRH Webinar covered decontamination systems for respirators, including specific methods for decontamination, evidence of potential effectiveness, and best practices and common challenges in emergency use authorization request submissions. The Webinar focused on N95 respirators, the disposable facepiece filtering respirators that cover a user’s airways or nose
Devices
FDA says that as part of a CME America 4/27 recall of BodyGuard infusion system administration sets used with the company’s BodyGuard infusion pumps, the company conducted additional flow-rate accuracy testing. “The testing revealed that some infusion sets do not meet the ± 5% delivery accuracy for the
Devices
FDA says that Endologix has issued a correction notice for its Ovation iX system that identifies the root cause of polymer leaks. FDA has classified the action as a Class 1 recall. An agency notice says that no physical removal of the product is planned or needed. The agency says
Devices
FDA has approved an Edwards Lifesciences PMA for the Konect Resilia aortic valved conduit, a ready-to-implant device for bio-Bentall procedures, a complex surgery that involves replacement of a patient’s aortic valve, aortic root and the ascending aorta. The device features the company’s Resilia tissue, which
Devices
FDA has published a guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, to satisfy requirements in the law and the MDUFA 4 commitment letter to provide final guidance documents. “The agency has concluded that it
Devices
FDA has published a guidance, Clinical Investigations for Prostate Tissue Ablation Devices, with recommendations for complying with the clinical testing special control for 510(k)s for high-intensity ultrasound systems for prostate tissue ablation. The document also makes recommendations for collecting clinical data to support marketing submissions for new
Devices
FDA has granted Revamp Medical a breakthrough device designation for its Doraya percutaneous device for treating acute heart failure (AHF). The temporary catheter, placed in the inferior vena cava below the renal veins, provides partial adjustable flow for up to 12 hours. “The device flow regulator mechanism is designed to
Drugs
FDA says it is planning to begin high-priority domestic inspections (on-site surveillance) for medical products and other regulated products during the week of 7/20. Resuming domestic inspections will depend on the data about the “virus’ trajectory in a given state and locality and the rules and guidelines
Devices
FDA has made available a draft guidance on “Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).” The document proposes the addition of several BPH treatment devices to a 2010 final guidance of the same name. Additionally,
Devices
FDA has cleared a Mim Software 510(k) for its deep learning auto-contouring software, Contour ProtégéAI. Contouring of the organs at risk is part of routine radiation therapy planning. “Auto-contouring is an ideal use case for deep learning algorithms because it is one of the most time-consuming
Devices
FDA has made available a draft guidance entitled “Select Updates for Peripheral Vascular Atherectomy Devices -Premarket Notification [510(k)] Submissions.” The document discusses software in atherectomy devices which may include a variety of functions ranging from ensuring that malfunctions that could be hazardous do not occur (e.g., cause injury,
Devices
The Coalition for Healthcare AI says that a strong regulatory framework that ensures the safety, efficacy, and equity of healthcare artificial intelligence (AI) is essential to ensure patient safety and allow clinical deployment. In a letter commenting on the agency’s earlier public workshop on the evolving role of AI
Drugs
Washington Legal Foundation has submitted a comment to FDA supporting the citizen petition of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information. The letter says FDA is running a suppression campaign that not only threatens the public health but also runs afoul of the Constitution. “By prohibiting clinical labs
Devices
FDA has cleared a Baxter International 510(k) for the AltaporeShape Bioactive Bone Graft, which is intended to enhance bone growth and help achieve fusion. The clearance was based on a 2019 prospective, open-label, non-randomized clinical study that evaluated 102 patients with degenerative disc disease, spondylolisthesis and spinal
Devices
FDA says that interim results of a post-marketing surveillance study of Bayer’s withdrawn Essure permanently implanted birth control device show that Essure patients tend to have higher rates of chronic lower abdominal or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as
Devices
A 2/10-2/14 FDA inspection at Luminex Corp., Austin, TX, found Quality System Regulation and Medical Device Reporting violations in the firm’s work as a manufacturer of microsphere-based and PCR-based multiplexing systems for in-vitro diagnostic use or life science research use, including software and
Devices
Arrow International has recalled (Class 1) its Arrow AutoCAT 2 Intra-Aortic Balloon Pump and AC3 Optimus Intra-Aortic Balloon Pump Series because both devices have a part called the MForce motor driver that may break, char, and discolor the motor connector wires. The wire wear or breakage may lead
Devices
FDA has warned consumers and healthcare professionals about hand sanitizer products containing methanol. An agency notice says that methanol is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. “The agency has seen an
Devices
The American College of Radiology and the Radiological Society of North America say it is unlikely that FDA could provide reasonable assurance of the safety and effectiveness of autonomous artificial intelligence (AI) in radiology patient care without more rigorous testing, surveillance, and other oversight mechanisms throughout the total product life