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Biotech / Medical : HMSC- A simple breast cancer screening device -- Ignore unavailable to you. Want to Upgrade?

To: Dante Sinferno who wrote (110)	3/20/1998 11:35:00 AM
From: (no name provided)	Read Replies (1) \| Respond to of 246

Robert, Sorry. I was getting a little worked up. I have now indication that the FDA would withdraw approval. However, they can withdraw approval. They have not had to worry about this useless device for 15 years because it was not marketed. But now, as I see it, there is a problem. The fear I would have is that some physicians would actually use this device in lieu of mammography or that patients would not go to their scheduled mammograms because BreastAlert was negative. There is absolutely no evidence that BreastAlert can pick up tumors that mammography misses and more importantly it is clear that BreastAlert does not pick up 5-10% of tumors detected by mammography. I would conclude, therefore that BreastAlert is a dangerous device. It does not improve diagnostic accuracy when used adjunctively and when misused would result in misdiagnosis. Lastly, from the prospectus pg 34: (granted it is out of context) "there is a risk that FDA could reevaluate the bases upon which it granted the Company's 510k Market Rights" Read the prospectus in detail. Kafka666