Shuren's Center: FDA Device Chief Discusses Long Road To 510(k) Reform
FDA has put its proposals on the table for reforming the 510(k) pre-market clearance program, but the crucial activity will take place over the coming weeks as FDA fields comments and decides which initiatives will get the green light
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The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
Worldwide medtech sales totaled $8.5bn in Q2, up 6.1%. Sales grew 8% in the US and 4.1% outside the US. Cardiovascular, surgery and vision were the primary growth drivers. Acquisitions and divestitures had net positive impact of 200 basis points, largely due to the acquisition of Shockwave Medical.