May 2015

toSense ™ receives 510(k) clearance for the CoVa™ Monitoring System

La Jolla, CA, May 27, 2015 – toSenseTM announced today receipt of 510(k) clearance from the Food and Drug Administration (FDA) for the CoVa™ Monitoring System (CoVa). CoVa features a novel body-worn Sensor for at-home patients with chronic illnesses, such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD...

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

The kBLASTER database has been updated today with FDA 510(k) clearances from April 2015 and FDA 510(k) splash pages for 510(k)s clearances in May 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).  

With more than 60,000 510(k)...

BrainScope’s Ahead 200 Device 510(k) Cleared by FDA for Adjunctive Assessment of Traumatic Brain Injury

Using Commercial Smartphone Technology, Second-Generation System Offers Objective Assessment of Mildly-Presenting Head Trauma Patients 

BETHESDA, Md.--()--BrainScope Company, Inc. announced today that the United States Food and Drug Administration (FDA) has 510(k) cleared the company’s Ahead 200 device. Using commercial smartphone...

CAScination Announces FDA 510(k) Clearance of its Navigation System for Liver Surgery

Bern, SWITZERLAND (May 8, 2015) – CAScination AG, a Swiss medical device company, announces FDA 510(k) clearance of its unique, award-winning surgical navigation system for open liver surgery. Being a pioneer in surgical navigation for soft organs, CAScination guides surgical instruments for effective tumor removal while sparing healthy parts of the liver. The CAS-ONE LIVER device (CE marked since 2010) is in active use in leading European cancer centers...

FDA withdraws older guidance documents

by Mark Hollmer at MassDevice

The FDA pulls 47 draft guidance documents it never made official, covering medical devices, diagnostics, pharmaceuticals and more. The FDA is withdrawing 47 draft guidance documents published before the end of 2013 that it never finalized or acted on.  Agency officials posted the announcement in the Federal Register, explaining that the move is designed to boost efficiency and transparency regarding its development of...