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The FDA Tuesday laid out separate requirements for 510(k)s for over-the-counter and prescription point-of-care blood glucose tests — a shift from current guidance that applies to all blood glucose monitoring systems. Read More
AdvaMed and Taiwan’s medical device association have signed a memorandum of understanding aimed at supporting medtech innovation and advancing patient care. Read More
A Tuesday appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immediate relief for manufacturers — though the line of questioning suggested some judges were sympathetic to industry’s free speech argument against the rule. Read More
Medtronic’s Symplicity renal denervation system for the treatment of uncontrolled hypertension failed to meet a primary endpoint in its U.S. pivotal trial, putting a surprising halt on a technology that had been expected to be a major revenue driver. Read More
Devicemakers must include information on potential pediatric use in most new device submissions under an FDA final rule that takes effect April 10. Read More
SinuSys plans to launch its Vent-OS two-step osmotic expansion sinus dilation system immediately in certain U.S. markets, following receipt of FDA 510(k) clearance. Read More
Manufacturers looking to register devices in India will have to take into account a detailed guidance issued by India’s Central Drugs Standard Control Organization on submission requirements for the registration, reregistration and import of certain diagnostic kits. Read More
Racer Technology, a Singapore maker of cochlear implant accessories, expressed confusion about the term “device history record” during a recent FDA inspection, drawing a warning letter from the agency. Read More
Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency. Read More
The FDA has granted 510(k) clearance for Israel devicemaker EarlySense to market an updated version of its EarlySense bedside monitoring system, the company announced Wednesday. Read More