Submitted by kBLASTER Team on
On February 24, FDA hosted a webinar with an accompanying slide deck to discuss final guidance documents on medical device data systems (MDDS) and mobile medical apps (...
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by Fort Mill Times
VALENCIA, CALIF. — Bioness, Inc. announced that the U.S. Food and Drug Administration (FDA) has 510(k) cleared the StimRouter®, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin. The StimRouter is the only implanted device to be cleared by the FDA with a specific indication for peripheral nerve stimulation.
With an estimated 50 million people suffering...
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by Sharon DeGrove Bishop, RAC, for RAPS.org
With respect to FDA 510(k) premarket clearances, the country where the submitter is located doesn’t have any bearing on how long it takes to get clearance from the FDA. Or does it?
Note: Review times for 2014 will change as more submissions are processed through review. Average review times are trending upward – over the past decade, they have roughly doubled. The average review time for Outside-of-US (OUS) submissions is about 15% greater than that for US submissions.
This doesn’t mean that the...
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by David A. Mann for Louisville Business First
Louisville-based Neuronetrix Inc. has received U.S. Food and Drug Administration 510(k) clearance for a medical device that measures brain activity.
The device, called the Cognision, has been in development for more than 10 years. It collects data that can be used to evaluate several neurological and cognitive disorders, including ...
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with FDA 510(k) clearances from January 2015 and FDA 510(k) splash pages for 510(k)s clearances in February 2015. 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
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by kBLASTER Team
The FDA recently released two final guidances on Medical Device Data Systems (MDDS) and Mobile Medical Applications. Both of these were guidances were released simultaneosly and intended to be consistent with each other. The goal of these guidances was to clarify for ...
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by Dr. Joe Smith for West Health Blog
Last week, we were really excited to see a portfolio company of the West Health Investment Fund hit a pivotal milestone in their mission when Sotera Wireless announced their Wireless ViSi Mobile Patient Monitoring System received a 510(k) clearance from the FDA to transmit patient’s vital signs.
When people ask me what kinds of companies the West Health...
Submitted by kBLASTER Team on
Submitted by kBLASTER Team on
Submitted by kBLASTER Team on
Roche (SIX: RO, ROG.VX; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas® MRSA/SA Test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus...