On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October
Tracking Vital Signs, Without the Wires
In the New York Times on Sept 3, 2011 – The article starts ‘CONFINED to their hospital beds, patients can only fantasize about stripping off all the wires that connect them to monitors and bolting for the door…’
Boston Scientific CRV Launches iPad App CardioTeach™
From MedicalDeviceSummit on Nov 10, 2011 – ‘The new iPad app CardioTeach has been touted as industry’s first at helping doctors communicate heart disease and treatment options to patients.’ There is a video demonstration of the CardioTeach™ iPad app Apple
MD&DI Interview Leo Eisner re:NB-MED Draft Doc EN60601 Implementation for EU
On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.
DRAFT results implementation of 3Ed (EN60601 series) for CE marking
This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN