Eisner Safety Consultants

In an article from MedCityNews.com on Dec 12, 2011 has an interesting take on a top 10 medical city list.  They look at it from the traditional lists to looking in the future with their fortune telling crystal ball.  For anyone in the Life-Sciences and Healthcare industry take a look to see how you will fair in your city now and in the future.

Check it out here

The GHTF has been around for almost 20 years and is in the process of disbanding to become a more Regultor focused group called the International Medical Device Regulators’ Forum (IMDRF).

In the Eucomed 18 Nov 2011 newsletter article they say “In March 2011, the regulatory authorities of the … GHTF took the decision to disband the GHTF … to be replaced by a ‘regulator-led harmonisation and collaboration group.’ … regulatory authorities felt that it was time to change the way the GHTF was operating so as to accelerate international medical device regulatory harmonisation.

For more details see the Eucomed newsletter article.

On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October 25, 2011 to November 28, 2011.

In the Federal Register Notice the FDA said “The agency believes that this wil allow adequate time for interested persons to submit comments without significantly delaying action by the agency.”

Per a Mass Device web article of November 8, 2011 “The draft guidance is intended to update a 1977 guidance document, ‘Deciding When to Submit a 510(k) for a Change to an Existing 510(k).’ It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.”

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…’

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 AppStore iPad link for the CardioTeach™