Provider

By Dave Muoio 03:56 pm March 25, 2020
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA. The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...

Source: Flow

By Tammy Lovell 05:40 am March 25, 2020
Clinical psychologists at medical device firm Flow Neuroscience have offered guidance to support and manage mental health during the COVID-19 pandemic. The Swedish startup says that its brain stimulation headset is a modern drug-free treatment for depression, which does not require health services, such as the NHS.  Clinical studies published in the New England Journal of Medicine and the British...
By Laura Lovett 04:30 pm March 24, 2020
Looking to better track the spread of the novel coronavirus, a team of engineers from some of Silicon Valley's most notable companies has joined forces with Boston Children's Hospital's Chief Innovation Officer John Brownstein on a new tool dubbed covidnearyou.org. The platform aims to gather data from people at home and report it back to public health organizations like the CDC. "[We] were...
Doctor using a computer.
By HIMSS 03:09 pm March 24, 2020
By Dave Muoio 02:49 pm March 24, 2020
Apple's Siri has been updated to provide symptom-based guidance and, in some cases, telehealth-app download links to users seeking COVID-19 information from the virtual assistant. Now, when users ask Siri a question along the lines of "How do I know whether I have coronavirus?" or "I think I have coronavirus," the tool initiates a new conversation tree to determine the user's current symptoms....
By Dave Muoio 04:32 pm March 23, 2020
Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA. On Friday evening, the agency released an alert to consumers...
By Laura Lovett 02:16 pm March 23, 2020
Social media giant Facebook is offering free developer resources to governments looking to use its messenger service as a coronavirus response. “[W]e’re launching a global program to connect government health organizations and UN health agencies with developers that can help them use Messenger most effectively to share timely and accurate information, and speed up their responses to concerned...
By Dave Muoio 04:50 pm March 20, 2020
The FDA announced today a new policy that permits expanded use of connected, non-invasive remote vital sign monitors until the end of the COVID-19 public health emergency. The agency is relaxing its prior guidance so that healthcare teams can monitor their patients outside of the hospital with certain devices that were previously cleared by the FDA, thereby freeing up space for the high volume...
By Dave Muoio 02:43 pm March 20, 2020
Editor's note: Since the publication of this story, the FDA has released an alert warning that it "has not authorized any test that is available to purchase for testing yourself at home for COVID-19." MobiHealthNews has reached out to Scanwell Health, myLAB Box and others about their at-home services: read the updated story here. Scanwell Health and myLAB Box are the two latest at-home...