Tuesday, November 18, 2014 10:19:34 AM
Say what:
"This interaction has led us to recently finalize plans for a new U.S. study aimed at evaluating the usability of the Dario™ and its accuracy in the hands of end-users, and we are commencing this study imminently."
Seiously??? Does Erez understand that a 510K study under NO CIRCUMSTANCES requires a "study"? Does he understand that NO study will affect the FDA decision process? Not to mention that apparently it took them almost a YEAR to figure out this alleged "study" was "needed" for approval.
For a 510K, the ONLY thing the FDA does is COMPARE the device to OTHER similar devices! Given Labstyle's near bankrupt condition, what kind of idiot management would spend money to initiate a "study" that WON'T have ANY effect on the approval process?
Indeed, if you think about it, WHAT "evidence" would they be seeking? The thing is a GLUCOMETER, for godsakes! It operates like every other glucometer -- presumably! What's "different" about dario that makes "usability" an issue that needs "evaluating"?
Sounds to me more like DRIO is just preparing excuses for further delays BEYOND this year and for reasons to execute yet more PIPES.
Recent DRIO News
- /C O R R E C T I O N -- DarioHealth Corp./ • PR Newswire (US) • 10/08/2024 01:09:00 PM
- National Medicare Health Plan Partners with Twill by Dario to Promote Healthy Aging with New Digital Mental Health Benefits for Seniors • PR Newswire (US) • 10/01/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/20/2024 08:05:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/13/2024 08:05:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/12/2024 08:37:42 PM
- Dario Introduces Integration of Twill Behavioral Health Capabilities into Cardiometabolic Health Solution to Enhance Member Engagement and Outcomes • PR Newswire (US) • 09/12/2024 12:30:00 PM
- Dario Publishes New Research Revealing How Physical Activity Mediates the Impact of Depression on Blood Glucose Levels in Individuals with Diabetes or Prediabetes • PR Newswire (US) • 09/10/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/10/2024 10:00:13 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/28/2024 10:12:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/23/2024 08:05:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/23/2024 08:05:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 08:01:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 08:01:15 PM
- DarioHealth Reports Second Quarter 2024 Financial and Operating Results • PR Newswire (US) • 08/08/2024 10:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/08/2024 10:05:39 AM
- DarioHealth to Report Second Quarter 2024 Results on Thursday, August 8th • PR Newswire (US) • 07/30/2024 12:30:00 PM
- Dario Expands GLP-1 Solution Client Base with New Employer Contract • PR Newswire (US) • 07/16/2024 12:30:00 PM
- Dario Demonstrates 12 Months of Sustained Healthy Behavior Change for Members Taking a GLP-1 • PR Newswire (US) • 06/25/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:02:27 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:01:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 12:30:15 PM
- Empowering Commercial Expansion: DarioHealth Announces Strategic Reorganization and Appoints Inaugural Chief Commercial Officer • PR Newswire (US) • 06/05/2024 12:30:00 PM
- DarioHealth Reports First Quarter 2024 Financial and Operating Results • PR Newswire (US) • 05/15/2024 10:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 10:06:09 AM
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