Category: Standards

Standards

Latest

FDA Clears Boston Scientific Insertable Cardiac Monitor

Boston Scientific has received 510(k) clearance from the U.S. FDA for the LUX-Dx Insertable Cardiac Monitor System, a device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke, and syncope.

Standards

Popular

The Great Wait: Will the FDA Increase Service Regulations or Not?

Since March 2015, the FDA has been collecting information and receiving factual and anecdotal comments concerning whether there is a public health and safety issue that warrants increased regulation and oversight of medical device companies and individuals. This issue culminated in October’s two-day workshop of presentations to the FDA, which biomedical expert Patrick Lynch details in the latest installment of The LynchPin.

Servicing Legislation

Latest

MITA, AdvaMed Out of ‘Collaborative Community.’ Now What?

Here, G. Wayne Moore, Acertara Acoustic Laboratories CEO and 2020 Ultrasound Chair for the MITA Ultrasound Section, reveals why MITA and industry peer AdvaMed withdrew from the FDA’s “Collaborative Community” initiative in May and what that may mean for the future of the group.