FDA Clarification Requested

We requested FDA clarification on the new regulations concerning Medical Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices.

Read our letter here.

IAMERS Medical Device Excise Tax Letter

Here is a copy of the letter from Rob Kerwin, General Councel for IAMERS, to Kara Getz, Esq., Tax Counsel to the Hon. Richard E. Neal, U.S. House of Representatives, regarding the January 2013 Medical Device Excise Tax. It is our priority to get clarification from the Department of Treasury on whether or not the excise tax applies to pre-owned medical equipment.  We have requested a conference call with them to clarify this matter.

We will keep you posted on the progress.

CCTA and Angiography Go Head to Head with Acute MI Patients

Developers and users of CCTA are racing to win the fight and prove CCTA is better than invasive angiography. Here is the latest score published in Cardiovascular Business.

Request to Delay Medical Device Tax

To keep you updated with our efforts in Washington, below is a link to a letter that was sent to the US Senate Majority Leader requesting a delay in the medical device tax.

Read it here.

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