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abira

12/28/18 11:17 AM

#459 RE: skepticone #458

Restore FDA submission is mid-late January, 2019: https://stocktwits.com/brettayers/message/149204537 (If you haven't seen it already)

abira

12/28/18 11:28 AM

#460 RE: skepticone #458

Thanks for sharing this, it was a good read. Related with insurance coverage for Rewalk 6.0, the thing that worries me the most is the current update on Rewalk's 10-Q in the language of risk factors. For example:
"We have submitted medical device report (MDRs), to the FDA for numerous serious injuries relating to use of the ReWalk Personal system, and have initiated a voluntary correction related to certain use instructions in the device’s labeling, which the FDA classified as a Class II recall. If our product may have caused or contributed to a death or a serious injury, or if our product malfunctioned and the malfunction’s recurrence would be likely to cause or contribute to a death or serious injury, we must comply with the FDA’s MDR regulations, which could result in voluntary corrective actions or FDA enforcement actions, such as mandatory recalls."

The bolded part didn't exist in previous quarterly reports, even though I am pretty sure that the injuries due to Rewalk happened all along. I can't necessarily assess how serious these injuries are or whether they can be prevented but that's a significant worry if one's going for broad insurance coverage.