Garwood Medical Devices LLC's biofilm disruption device, Bioprax, has received breakthrough device designation from the U.S. FDA. Bioprax turns metal implants into electrodes and uses low-voltage electricity to eliminate the bacteria associated with biofilm infections.
Dental devices would likely strike most observers as fairly simple items, but an FDA employee said on a recent webinar that these filings have a refuse-to-accept (RTA) rate in excess of 80%, suggesting sponsors have a lot of regulatory homework to do. The FDA finalized the RTA policy for 510(k) devices in September 2019, wrapping up a draft that originated in 2012, but which is on the second iteration.
The U.S. FDA's draft guidance for labeling and patient information for breast implants addresses concerns over anaplastic large cell lymphoma, but the draft also recommends biennial examination via ultrasound or MRI after five years, a recommendation that could prove a boon to makers of these imaging systems.
A recent medical journal article says the terminology used by physicians to denote a fatality in the FDA adverse event reporting system has led to underreporting of fatalities associated with two prominent cardiology devices, a predicament the authors say skews the public understanding of these devices' safety profiles.
The FDA's September 2019 final guidance for the humanitarian device exemption program brought some clarity to several issues, but device makers must still untangle the question of which tasks an institutional review board (IRB) has delegated to an appropriate local committee for a specific clinical site.
The U.S. FDA has given 510(k) clearance to the Advanced Intelligent Clear-IQ Engine (AiCE) for Canon Medical Systems USA Inc.'s Aquilion Precision CT scanner. The regulatory green light brings artificial intelligence (AI)-based image reconstruction capabilities to the world's first ultra-high resolution CT imaging system.
Sky Medical Technology Ltd. has cinched FDA clearance for a third indication for its geko device, a noninvasive, battery-powered wearable technology designed to increase blood flow in the deep veins of the lower legs. The Daresbury, U.K.-based company already had the agency's blessing for geko's use immediately after surgery to stimulate the calf muscles to prevent venous thromboembolism (VTE) and preoperative reduction of edema. Now the FDA has granted geko 510(k) clearance for stimulation of calf muscles to curb venous thrombosis in nonsurgical patients at risk of VTE.
WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval.
Prostate cancer affects roughly 1 in 9 American men in their lifetime, with 174,650 new cases reported each year. However, current prostate specific antigen (PSA) tests lack specificity, leading to overdiagnosis and overtreatment of inconsequential cancers. Cleveland Diagnostics Inc. is looking to change that with its IsoPSA assay, which just received a breakthrough device designation from the U.S. FDA. In clinical studies, the noninvasive, blood-based test has been shown to have higher accuracy than standard PSA tests.
The U.S. FDA has posted its guidance agenda for this still-young fiscal year (FY), a list that covers topics such as Clinical Laboratory Improvements Amendments (CLIA) waivers. However, the agency appears to be concerned about a lack of compliance with Section 522 postmarket surveillance studies, as indicated by the inclusion of the related guidance in the high priority list for do-overs in fiscal 2020.
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