Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways, in September 2019.
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.
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.
UL LLC, of Northbrook, Ill., has concluded a two-year cooperative research and development agreement (CRADA) with the U.S. Department of Veterans Affairs (VA), a program that verified that the UL 2900 standard provides a more seamless cybersecurity blanket for connected medical devices. UL said this marks is an important step toward the development of cybersecurity tools that ensure that devices can be used without undue risk to patients.
LONDON – As the May 2020 deadline for complying with the EU Medical Device Regulation (MDR) looms large, companies have been handed a further requirement they must meet if their products contain certain phthalate plasticizers. Phthalates are widely used to make polymers, in particular polyvinyl chloride (PVC), flexible. That allows it to be shaped into intubation tubes, catheters, blood bags, ventilator masks and other health care products. But the chemical bonds between phthalates and polymers are weak, and it is known they can leach into blood and other liquids, as well as be released into patients through mucous membranes.
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