Devices
FDA has cleared a Vapotherm 510(k) for the latest version of its Precision Flow Hi-VNI system, which includes a new product category and product code (QAV). The agency also granted an expanded indication for the device — to augment breathing of spontaneously breathing patients suffering from respiratory distress in
Devices
A 5/16-8/1 FDA inspection at the Becton Dickinson manufacturing facility at Franklin, WI, found Quality System Regulation violations in the manufacture of a pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe. A 9/14 Warning Letter says specific violations
Devices
Qualigen has submitted a 510(k) for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay, indicated for the quantitative determination of SHBG in human serum and plasma as an aid in diagnosing androgen disorders. “When used in conjunction with our currently available FastPack Total Testosterone Assay, it will provide
Devices
FDA has cleared an Eximo Medical 510(k) for the B-Laser Atherectomy System for treating peripheral artery disease. The 355nm wavelength laser is designed to treat infrainguinal stenoses and occlusion, including in-stent restenosis, according to the company. Clinical data demonstrated that the device “provides significant advantages over traditional
Devices
FDA has classified as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA System and the risks associated with Type III endoleaks. The device is indicated for treating abdominal aortic aneurysms. The 7/20 safety notice provided updated information on comparative AFX Type
Devices
FDA has allowed the de novo marketing of Bose Corp.’s Bose Hearing Aid, the first hearing aid that enables users to fit, program and control the device without assistance from a health care provider. The device is intended to amplify sounds for individuals 18 years or older with perceived
Devices
FDA has approved a Zeiss PMA for ReLEx Smile to expand myopia treatment to patients with astigmatism. The approval also provides for a small entry incision to be made, allowing the Smile procedure to be less disruptive to the corneal surface tissue, the company says. The device uses the femtosecond
Devices
FDA has cleared an Applied BioCode 510(k) for its BioCode Gastrointestinal Pathogen Panel and its use with the high throughput BioCode MDx-3000 molecular system. The panel tests for 17 most common bacteria, viruses, and parasites that cause infectious diarrhea, according to the company. The clearance is based on
Devices
Washington Legal Foundation (WLF) is asking the Utah Supreme Court to adopt the exception to strict product liability for implanted medical devices that has long applied to prescription drugs. In its amicus brief in a case certified to the state court by the Utah federal court, WLF says that strict
Devices
Adoption of coordinated voluntary disclosure (CVD) policies by medical device manufacturers to promote medical device cybersecurity and patient safety supports public health and safety and also provides manufacturers with a number of legal and non-legal benefits. That’s the conclusion of the Medical Device Innovation Consortium, which includes an
Devices
Unplug the Robot member Jennifer Nelson, who says she has had to have multiple surgeries and other procedures in an effort to repair damage caused by a DaVinci Robotic permanent cautery instrument, is petitioning FDA to “seriously revisit and reconsider the issue of banning and recall of all permanent cautery
Devices
CDRH has released a list of 11 final and 10 draft guidance topics (A-List) that it intends to publish this fiscal year. The post also includes a list of five final and two draft guidances (B-List) that will be published as resources permit, and a list of 20
Devices
A 3/19-6/11 FDA inspection at Datascope Corp., Fairfield, NJ, found Quality System regulation and Medical Device Reporting regulation violations in the firm’s manufacturing of the Sensation Plus 8Fr intra-aortic balloon catheter, Mega 7.5 Fr intra-aortic balloon catheter, Sensation Plus 7.5 Fr intra-
Devices
FDA has cleared an Acessa Health 510(k) for the Acessa ProVu System, an integrated radiofrequency ablation, ultrasound visualization, and guidance mapping system for treating women with symptomatic uterine fibroids. The company says the device can treat nearly all sizes and locations of fibroids, including those outside the uterine cavity
Devices
Oscor Inc. has recalled its TB Temporary Bipolar Pacing Lead (unshrouded 2 mm Pins Models) due to connectivity concerns. During the use of some TB Leads, featuring the 2mm unshrouded connectors, the cap housing may slide and potentially expose the connection wire, a recall notice says. “In some instances, this
Devices
Ventana Medical Systems has recalled (Class 1) multiple detection kits due to a potential for false negative results caused by reagent dispenser issues The detection kits use the company’s Flo-Lok III Dispenser and contain staining chemicals (reagents) used during immunohistochemistry lab tests. The dispensers release reagents that change
Devices
FDA says it is preparing a significant update to its guidance on “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” For example, the new draft guidance will “highlight the utility of providing customers and users with a ‘cybersecurity bill of materials’ – a list of commercial or off-
Devices
FDA 10/1 launched a revised Special 510(k) Pilot Program that aims to expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. As part of this pilot, certain design or labeling changes that previously were reviewed as a traditional 510(
Devices
FDA has cleared a de novo request to permit the marketing of Adaptive Biotechnologies’ ClonoSEQ assay, a next-generation sequencing-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia or multiple myeloma. An FDA release says MRD is a measure of the amount of cancer cells
Devices
FDA commissioner Scott Gottlieb says the agency’s approach to digital health isn’t to regulate the everyday health and lifestyle uses of consumer devices, but rather to focus its resources on reviewing more sophisticated medical apps that sit on top of the general purpose hardware — the functions that have
Devices
FDA has issued a draft guidance, The Special 510(k) Program, that would update the Special 510(k) program to clarify existing policy and expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. The agency says the update includes certain changes
Devices
FDA is asking manufacturers of pen needles used with pen injectors to deliver medication to consider changing the labeling by adding a Warning that both the outer cover and the inner needle cover should be removed before an injection. The letter says FDA is aware that in some cases, the