Bioelectronics Corp (BIEL)

[kidnova]

Ms Whelan had this to say about the FDA's recent decision, "In the May 21 discussion with the Orthopedic & Rehabilitation Devices Panel of the FDA, our products were arbitrarily placed in Class III, along with all shortwave diathermy devices. A handful of studies were picked to show that effectiveness had not been proven." Whelan mentioned that all diathermy devices were also seeking reclassification, including Diapulse.

If Ms. Whelan actually said this then she is woefully ignorant of what actually took place at the panel discussion. BIEL's products weren't "arbitrarily placed in Class III", they've been Class III devices all along. I hope BIEL isn't paying this lady to write articles because she clearly has no idea what she's talking about.