Bioelectronics Corp (BIEL)

[alexander77]

Proof that de novo was filed in June:

Allay™ Menstrual Pain Therapy
For its Allay menstrual pain relief product, BioElectronics has formally requested the change of its application from a 510(k) to Section 513(f)(2) de novo review. This classification request is being bolstered by additional research and clinical evidence that demonstrates the effectiveness of electro medicine treatments as an effective therapy for dysmenorrhea. Last week, Health Canada issued a license to market the Allay™ Menstrual Pain Therapy in Canada.



http://www.marketwire.com/press-release/BioElectronics-Advances-in-Its-FDA-Clearances-1277016.htm