First-Of-Its-Kind Stroke Rehab Device Approved By FDA
The Vivistim System stimulates the vagus nerve with small doses of electrical shock to help rehabilitate stroke patients. It received premarket approval after qualifying as a breakthrough device.
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Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates
In this roundup of developments in digital health, we highlight the key news and announcements from August and September.
The US agency published a paper that’s based on recommendations from experts and other stakeholders on how to best let patients know their device may be vulnerable to a cybersecurity attack.
Booz Allen Hamilton’s report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.