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 But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA.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...
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...
In 2012 The Wall Street Journal published a story that quoted a big medical device company spokesperson explaining that they couldn't provide patients the medical device data gathered by implanted devices inside their own bodies because regulators wouldn't allow it.
"Medtronic says federal rules prohibit giving Ms. Hubbard's data to anyone but her doctor and hospital. 'Our customers are...
Next month the FDA is hosting a public advisory committee meeting to discuss a change to the intended use of Dexcom's G5 Mobile Continuous Glucose Monitoring System (CGM) device that would allow the company to market the G5 as a CGM patients can base treatment decisions on.
Currently, Dexcom's CGMs are considered adjunctive devices, which means they carry an asterisk that notes they are intended...
Considering recent events, big name consumer brands are more likely than ever to move into regulated medical devices.
Two weeks ago Apple CEO Tim Cook told a newspaper that while his company wouldn't put the Apple Watch through the motions of an FDA clearance process, Cook "wouldn't mind putting something adjacent to the watch through it." He said that before adding maybe that'd be an app or...
By Bradley Merrill Thompson
Healthcare in America needs disrupting. The media has widely reported on the high cost of, and poor outcomes produced by, the US health care system. Fortunately, attracted by possible profit in a market that currently constitutes over 17 percent of GDP, quite a few startups are anxious to do the needed disrupting. Indeed, innovators from many places outside of...
By Bradley Merrill Thompson
With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of facets to it, but in this post I want to focus on the most important – the intended use of the app. This concept of intended use is indeed not just the determining factor...
By Bradley Merrill Thompson
Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps. Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well...
Kinsa's smartphone-connected thermometer
The US Food and Drug Administration has proposed to largely deregulate a sizable list of Class II and Class I medical devices and no longer require their makers to go through the 510(k) process. The agency made clear the deregulatory move would not necessarily exempt the device makers from other steps like appropriately registering and labeling their...
Vital Connect's HealthPatch
This past month the FDA cleared two mobile medical apps and one digital health platform as 510(k) Class II medical devices.
McKesson, one of the most vocal health IT companies lobbying for changes to how the FDA regulates medical software, secured clearance for a mobile medical app called McKesson Cardiology ECG Mobile. The web-based version of McKesson Cardiology...
