FDA
Bodysphere's announcement was spread across a number of mainstream news and social media channels before the company released a statement that explained its misunderstanding.
Also Cue Health scores $13 million from the department of Health and Human Services Biomedical Advanced Research and Development authority in order to fund its portable COVID-19 diagnostic test.
The HIMSS Media team gives a recap of recent headlines surrounding the FDA, COVID-19 and new digital health software products.
Dr. Yuri Maricich, chief medical officer at Pear Therapeutics, speaks on his company's experience bringing a digital therapeutic product through the regulator's experimental program for health software.
Somryst, a prescription digital therapeutic combining cognitive behavioral therapy and personalized sleep restriction, is the first software product to put the FDA's early Precertification Program framework through its paces.
The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool both employed AI to help Butterfly iQ users more easily evaluate the patient's condition.
Nurx, Carbon Health and Everlywell have officially halted their mail-order testing-kit services. But at least one startup is still moving to secure an Emergency Use Authorization for its at-home rapid serology diagnostic.
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
Privacy & Security
"SweynTooth" impacts several microchip and medical device manufacturers, and could allow bad actors to wirelessly crash or access these products, according to the agency.
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.