FDA Formally Classifies Cardiac Surgery Device, Robotic Arm
Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.
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Robotic Arm Inventor Says 18 Months ‘Too Long’ To Approve Novel Device
US FDA needs to speed up its approval procedures for review of revolutionary devices like the LUKE prosthetic arm, says its inventor Dean Kamen. The arm was launched by Mobius Bionics on July 8. Kamen took a few moments after testifying at a House robotics hearing to explain its capabilities to Medtech Insight and share his thoughts about the FDA device review process and the spirit behind the 21st Century Cures bill.
US Approvals Analysis: July A Good Month For PMAs; 510(k)s Down In 2016
A look at Medtech Insight's Approval Tracker data shows that last month was a relatively active one for US FDA approvals of novel devices via the PMA, panel-track supplement and de novo routes. But 510(k) clearance totals are down so far in 2016 compared to recent years.
MDSAP Audit Allows Emerging Firm To Expand Internationally
Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight.