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Latest From Intersect ENT
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of July 23 to 29 was another slow one for FDA approvals, with no new PMAs, panel-track PMA supplements, de novos, or non-US approvals.
The Israeli portfolio company of The Trendlines Group announced that US FDA 510(k)-cleared its composite removable sinus stent system based on results of a 30-patient trial.
US FDA approved a New Drug Application for Intersect ENT's Sinuva mometasone furoate-eluting sinus implant in December. The implant elutes the cortical steroid to treat recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery and is supported by data from 400 patients, including the results from the RESOLVE II trial that showed Sinuva dramatically reduced the proportion of patients who needed another endoscopic sinus surgery.
A sortable and searchable table of FDA original PMAs and panel-track supplements approved in calendar year 2016, updated monthly. Latest update: approvals through March 31.
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- Drug Delivery
- Implantable Devices
Surgical Equipment & Devices
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- Fiagon AG Medical Technologies