rockenrosco2010, a crew (I mean the old crew of Cambridge Heart) that could not sell this technology must have had their brains in a pot. This technology (SA MTWA) can save thousands of lives and billions of dollars. I believe, somehow, somewhere, Cambridge Heart will come back.
Get this straight! GE MMA cannot file payments under Cambridge Heart's SA MTWA method because the SA MTWA method is only authorized. You are wrong to believe GE will or can file payments under the Cambridge Heart's SA MTWA filing code for Medicare. It would be fraud if GE did this. I don't think GE or the doctors that offer this test to their patients wants to be engaged in a fraud allegation.
Hotstock13, Maybe you work for GE, a stock manipulator, or an organization that hates Cambridge Heart's technology. CAMH's SA MTWA method is superior to the GE MMA method but both are approved by the FDA. Here is the big difference. CAMH SA MTWA method is also approved by the CMS, a second governmental organization, in addition to the FDA. In a proposed decision Memo, dated Oct 23, 2014, for MTWA (CAG00293R2), Tamara S. Jensen, Director of the Coverage and Analysis Group said the SA MTWA method by Cambridge Heart is better/superior to the GE MMA method and are not comparable. In this memo, Ms. Jensen, again approved of the SA MTWA method and disapproved the GE MMA Method for the Center of Medicare Services.
Also, The FDA sent a letter to Mr. Wahlig of GE, dated Dec 3, 2002 stating the following: ...Please be advised that FDA's issuance of the substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act.... It only authorizes GE to begin marketing their product.
Hotstock13, A FDA 510K approval only says the medical equipment will not harm or is effective as a comparative product. Is called a Summary of Safety and Effectiveness. If you want, you can look this up for yourself. The GE Medical Systems Information Technologies T-Wave Alternans (TWA) Modified Moving Average (MMA) systems was approved by the FDA in a summary Oct 4, 2002. So, what you are saying is nothing new. In 2002, the FDA compared the GE MMA method to the CASE 8000 Exercise Testing System.