RE: RE: Reality My query yesterday dealt with a poster's claim that ''EKG was the only over the counter 'MONITOR' available to the public''.
I'm sure most of you realize that the statement as it stands is patently incorrect...there are all sorts of ''MONITORS'' out there ...of varying sophistications ( most are simple heart rate monitors ).... athletes, triathletes and work out buffs use them regularly. So it's either a poor choice of words or merely reinforces that many of the folks here haven't really researched the 'Pen'. The device itself is not terribly unique......it's more sophisticated than a standard run of the mill monitor.....but it's likely that the GEMSA software program available for use with it that makes it a little more intriguing.
Given that reality....that it's not the 'only' monitor....and we agree to go beyond .....a few of you were kind enough to raise the points that it is still either the ''first'' ..or ''only'' product of it's type.
I trust you have carefully read the details of the FDA approval for the 'over the counter' sale of the product as a prerequisite to what is being discussed here.......
Initially...I was directed to the company's News Release...the headline of which proclaimed
''CARDIOCOMM SOLUTIONS, INC. RECEIVES FDA CLEARANCE TO MARKET FIRST OVER-THE-COUNTER HEART MONITORING SOLUTION''
If you've read the FDA approval....you will realize unequivocally ( by the FDA's acknowledgement ) that it is NOT the 'first' over the counter monitoring device of its type. The Company's wording, I believe, is that it is the first ''Solution''...which is entirely subjective....and most likely based on EKG's considered opinion that its GEMSA software that comes with the pen and allows for uploading and transmitting of the data to their monitoring centre makes it unique....or a 'first' in their eyes !!
Now ....please read the above referenced news release for yourself.....I'm sure you can locate it.....the words ''first'' or ''only'' with reference to the device never show up in the actual official release.
So you could say it's nit-picking....but ....big BUT......the FDA over the counter approval will give you the actual facts of the matter. The approval refers specifically to two equivalent products previously approved ....( the 'predicate' devices ) and contains the following statements...............
''The proposed device ( referring to the Heartcheck Pen ) is a substantial equivalent to....( then names the two products ) . The proposed device has a similar intended use, technological and design characteristics as the predicate devices. Any minor differences do not introduce new issues of safety or effectiveness.
The point was raised that it's the only one that measures rhythm....if one researches the 'predicate' devices.. one will discover that both devices are quite capable of measuring rhythm...or arrhythmia.
In conclusion.... EKG's pen is not the first and it's not the only......that's neither good nor bad....it remains to be seen what impact it can or will make in a very complicated marketplace.