News

Does FDA Take Longer to Clear 510(k)s From Non-US Companies?

Submitted by kBLASTER Team on

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...

Neuronetrix gets FDA 510(k) clearance for brain-scan device

Submitted by kBLASTER Team on

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 ...

kBLASTER update February 2015: 510(k) search for predicates and successful 510(k) clearance strategy

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

...

FDA releases two final guidances on Medical Device Data Systems (MDDS) and Mobile Medical Applications

Submitted by kBLASTER Team on

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 ...

Sotera Wireless Gets 510(k) Clearance

Submitted by kBLASTER Team on

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...

Roche receives FDA clearance for next generation cobas MRSA/SA Test

Submitted by kBLASTER Team on

New test detects MRSA and SA, the leading causes of healthcare-associated infections worldwide

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...

SOFTWARE Act revision 'simplifies' health IT regulation

Submitted by kBLASTER Team on

By  for Fierce Health IT

A revised version of the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, currently circulating through Congress in draft form, takes a more "simple and straightforward" approach than its predecessor to health IT regulation, health attorney Brad Thompson tells FierceHealthIT....

Pages