The FDA has released final postmarket guidance for manufacturers of drug-device combination products. The guidance outlines how the agency expects manufacturers of combination products and those that make constituent parts of drug-device combinations to report adverse events and product malfunctions. Combination-product manufacturers will have five working days to report adverse events that require remedial action […]
Medtronic bids for expanded FDA indication for Guardian Sensor 3
Medtronic (NYSE:MDT) said it asked the FDA for an expanded indication for its Guardian Sensor 3 device that would open the glucose sensor up for Medicare reimbursement. The Fridley, Minn.-based medtech titan said it filed for pre-market approval of non-adjunctive labeling for Guardian Sensor 3 for use with its MiniMed 670G insulin management system. If […]
BD updates infusion pump recalls
Becton Dickinson (NYSE:BDX) said today it has updated two voluntary recalls of certain Alaris infusion pump modules and infusion sets used with those modules. The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices. The Alaris model 8100 modules were manufactured […]
Teva wins FDA approval for AirDuo Digihaler for asthma
Teva (NYSE:TEVA) yesterday said that it received FDA approval for its AirDuo Digihaler Inhalation Powder. The Israel-based company’s AirDuo Digihaler is a combination therapy digital inhaler with built-in sensors that can connect to a smartphone application, indicated to treat asthma in people 12 years and older.. It delivers a multi-dose dry powder of 113mcg of fluticasone […]
Nemaura bids for de novo clearance from FDA for SugarBEAT glucose monitor
Nemaura Medical (NSDQ:NMRD) this week said it submitted a De Novo medical device applications to the FDA for its SugarBEAT non-invasive glucose monitor. The Loughborough, England-based company recently successfully completed clinical studies and two summative human factors usability studies needed to support De Novo submission. “We are pleased to have submitted our De Novo 510(k) application […]
FDA issues final rule for appealing medical device regulatory decisions
By Stewart Eisenhart, Emergo Group A final rule recently issued by the US Food and Drug Administration explains procedures and timeframe requirements whereby regulatory decisions by the agency’s Center for Devices and Radiological Health (CDRH) may be appealed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, […]
Medtronic recalls MiniMed pump models on cybersecurity risk
Medtronic (NYSE:MDT) today recalled two models of its MiniMed insulin pumps after researchers discovered cybersecurity risks that could allow a hacker to take control of the devices. The recall affects 11 models in Fridley, Minn.-based Medtronic’s line of MiniMed 508, MiniMed Paradigm and MiniMed Paradigm Veo pumps, according to the FDA. Medtronic said the pumps […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
Ocular Therapeutix gains second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has approved a supplemental NDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested in January that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Dextenza is designed to deliver drugs for up […]
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