Submitted by kBLASTER Team on
by Business Wire
FREMONT, Calif. & PADOVA, Italy--(BUSINESS WIRE)--CenterVue, a world leader in eye disease prevention using innovative imaging technologies, today announced FDA 510(k) clearance for its EIDON true-color confocal scanner. EIDON is the first, fully-automated retinal imaging...
Submitted by kBLASTER Team on
by Globe Newswire
SOUTH JORDAN, Utah, Dec. 10, 2014 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received FDA 510(k) clearance for three products: the...
Submitted by kBLASTER Team on
by Anne Zieger at Nuviun
In a likely bid to unseat rival electronics maker Samsung, South Korean technology giant LG Electronics has gotten an FDA 510(k) clearance for a product called "LG Smarthealth." The move follows in the footsteps of Samsung, which got a related clearance for its S Health app last year, reports mobihealthnews.
To...
Submitted by kBLASTER Team on
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...
Submitted by kBLASTER Team on
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)...
Submitted by kBLASTER Team on
by Val Kennedy at MassDevice
Johnson & Johnson's (NYSE:JNJ) DePuy Synthes Spine unit has won U.S. regulatory approval for a titanium rod device for the treatment of a rare...
Submitted by kBLASTER Team on
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-...
Submitted by kBLASTER Team on
by StreetInsider.com
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...
Submitted by kBLASTER Team on
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....
Submitted by kBLASTER Team on
by Josh Sandberg at PRNewswire
SuperSonic Imagine (Euronext: SSI, FR0010526814), a company specializing in ultrasound medical imaging has received 510k clearance from the FDA for two new probes used with its...