Avalign and its Instrumed International subsidiary agreed to pay $9.5 million to settle federal charges that it sold medical devices that weren’t cleared for the U.S. market. The case, which has already cost Instrumed distributor CareFusion $3.3 million, involves devices that Instrumed claimed as pre-amendment devices that were exempt from FDA regulations instituted in May 1976. […]
From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]
Illinois surgical devices maker Instrumed GmBH is in the FDA’s cross-hairs after agency investigators turned up a slew of manufacturing violations during a July 2013 inspection of the company’s German facility.