You're welcome. Don't listen to folks who sold BIEL last year and have fallen asleep on the developments. In a nutshell, today's FDA Docket basically sets new standards for SWT clearance because BIEL's products are now treated as Shortwave Therapy (SWT) not Shortwave Diathermy devices. The old classification of pulsed shortwave devices was developed in 1970 and the standard for clearance depended on mechanism of action applying stringent standards that apply to high risk medical devices that fall into Class 3. In other words, FDA's classification for SWT/SWD was really outdated and had to be revised based on the Agency obtaining new, modern scientific evidence last year (at the FDA's Medical Advisory Committee, Orthopedic and Rehabilitation Panel where BIEL presented).
It is really a shame that the US FDA has not given BIEL clearance when health agencies in 40 countries have.
Now that there are guidelines set for special and general controls, BIEL can apply for clearance under Class 2 and submit additional, new data from the clinical studies that have been completed as of the end of last year. Take a look at what they have to submit per BIEL's shareholder update:
Did I read that BIEL has no new clinical data to submit to the FDA? Wrong again, it seems.