Philips receives FDA 510(k) clearance for IQon Spectral CT

by PRNewswire

Reinforcing its commitment to enabling confident diagnosis through innovation, Royal Philips (NYSE: PHG) today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its IQon Spectral CT, presenting an entirely new approach to spectral imaging. This first-of-its kind technology...

kBLASTER update December 2014: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from November 2014 and FDA 510(k) splash pages for 510(k)s clearances in December 2014. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  With more than 59,000 510(k)...

Firefly device receives FDA 510(k) clearance

by Today's Medical Developments

Buckinghamshire, United Kingdom – Officials from Firstkind Ltd, a subsidiary of Sky Medical Technology Ltd, announce FDA 510k clearance for U.S. commercialization of their sports recovery device, firefly, indicated for increased lower limb blood circulation to decrease muscle soreness after intense exercise and improve muscle performance.

The size of a wrist-...

Masimo Corp's (MASI) Radius-7 Receives FDA 510(k) Clearance


Masimo (NASDAQ: MASI) today announced FDA 510(k) clearance of Radius-7" for the Root patient monitoring and connectivity platform, the first and only wearable, wireless monitor with Masimo's breakthroughrainbow SET technology, offering patients continuous monitoring with freedom of movement.

With rainbow SET...

Vascular Solutions Receives FDA 510(k) Clearance for Turnpike Catheters

by Globe Newswire

Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Turnpike catheters, a new line of catheters designed for use in complex coronary and peripheral interventions. Vascular Solutions expects to launch the Turnpike catheters in January following clinical evaluations to occur in December....