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Posted On: 02/10/2020 6:46:41 PM
Post# of 8401
Looking forward to inked deals and the 10-Q results from this latest quarter. Moving forward, BIEL turns profitable. Let go of the past and focus on the future. BIEL has finally turned the corner!
I want to share an excellent post from Srinsocal over on IFLUB. Srin posts are all well researched and written and I applaud him on his due diligence. This one should help clarify any questions you may have regarding the recent FDA clearance.
Atlas1
Much Confusion Regarding FDA Device Approval/Clearance
Some would like us to believe that ActiPatch is an inferior Device because it used the 510k Process rather that the Pre Market Approval Process to get FDA Authorization to Market.
From the site referenced in post:
"Clearance: When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance."
"Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process. Following a successful submission of a premarket approval (PMA) or a Humanitarian Device Exemption (HDE), the device is given Approval by FDA."
Notice that this website considers the 'Approval Process' to be for Class III Medical Devices which are things like Heart Pacemakers and other devices that support of sustain life.
ActiPatch is a Class II Medical Device. All of the Class II Devices are given Authorization to Market through the 510k Process unless there is not a similar Device already on the Market, a Predicate Device. 95-98% of Medical Devices use the 510k Process.
One of the major differences between the 510K and the PMA Processes is Clinical Studies. 510Ks generally don't need them, PMA's always need them.
BIEL submitted 3 Clinical Studies to support their Full Body Musculoskeletal 510K. The FDA accepted all 3 Studies and found that in all 3"The results indicate that ActiPatch significantly reduced pain".
So BIEL has gone beyond what 95% of the Medical Devices on the Market have done, in providing 3 Clinical Studies to prove efficacy, and as such is superior to the average Medical Device.
I want to share an excellent post from Srinsocal over on IFLUB. Srin posts are all well researched and written and I applaud him on his due diligence. This one should help clarify any questions you may have regarding the recent FDA clearance.
Atlas1
Much Confusion Regarding FDA Device Approval/Clearance
Some would like us to believe that ActiPatch is an inferior Device because it used the 510k Process rather that the Pre Market Approval Process to get FDA Authorization to Market.
From the site referenced in post:
"Clearance: When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance."
"Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process. Following a successful submission of a premarket approval (PMA) or a Humanitarian Device Exemption (HDE), the device is given Approval by FDA."
Notice that this website considers the 'Approval Process' to be for Class III Medical Devices which are things like Heart Pacemakers and other devices that support of sustain life.
ActiPatch is a Class II Medical Device. All of the Class II Devices are given Authorization to Market through the 510k Process unless there is not a similar Device already on the Market, a Predicate Device. 95-98% of Medical Devices use the 510k Process.
One of the major differences between the 510K and the PMA Processes is Clinical Studies. 510Ks generally don't need them, PMA's always need them.
BIEL submitted 3 Clinical Studies to support their Full Body Musculoskeletal 510K. The FDA accepted all 3 Studies and found that in all 3"The results indicate that ActiPatch significantly reduced pain".
So BIEL has gone beyond what 95% of the Medical Devices on the Market have done, in providing 3 Clinical Studies to prove efficacy, and as such is superior to the average Medical Device.
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