On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and effective, and improve healthcare inequities.
The final guidance defines the FDA's interpretation of "more effective" as encompassing all the information about the device, including the risks and...
In late September, the FDA released its final report on the Software Precertification Pilot Program, which it launched in 2017 to explore different regulatory approaches for digital health tools.
By 2022, the agency determined a new regulatory framework would be useful for software as a medical device, but it couldn't do that alone.
"We are not fully capitalizing on these capabilities and...
Prescription digital therapeutic products can improve health for the underserved, especially in the area of mental health. Apart from addressing the severe shortage of mental health professionals by increasing access to care, recent science would suggest the digital therapeutic modality can be particularly effective at treating widespread conditions, including those made worse by the pandemic....
The Food and Drug Administration has granted AppliedVR De Novo clearance to market its EaseVRx virtual reality system to treat chronic lower back pain.
The prescription device includes a VR headset and controller plus a “Breathing Amplifier” that’s used to train the user in deep breathing. Patients can participate in 56 VR sessions that use cognitive behavioral therapy to treat pain. The...
The Food and Drug Administration is classifying the recall of the Ellume COVID-19 Home Test for giving false positive results as a Class I recall, the most serious type of recall.
The agency said the “use of these tests may cause serious adverse health consequences or death.” The false positives could delay diagnosis or treatment for another serious non-COVID-19 illness, further spread the virus...
The Food and Drug Administration is warning that certain lots of the Ellume COVID-19 Home Test may be giving false positive results due to a manufacturing issue.
The agency said negative results don’t appear to be affected, and that it’s working with the company to assess its manufacturing checks and take steps to fix the error.
Ellume is asking customers to check if their tests are part of the...
Digital chronic care company Welldoc has received its ninth FDA 510(k) clearance for its diabetes management platform BlueStar.
The new clearance, which was announced by Welldoc Wednesday, but approved by the FDA earlier this month, expands its earlier approval for insulin dosing support to include bolus and premixed insulin titration for Type 2 diabetes.
The Insulin Adjustment Program with...
Abbott landed FDA clearance for its imaging software, which employs artificial intelligence to give doctors a clearer look at blood flow and blockages in heart vessels.
The Ultreon 1.0 Software pairs optical coherence tomography with AI to help physicians make decisions about next steps for treatment.
"As cardiologists continue to adopt OCT and move away from traditional imaging methods such as...
This week, the Food and Drug Administration shared that it will allow marketing for some COVID-19 screening tests before their effectiveness is studied in asymptomatic individuals.
Test developers seeking this over-the-counter authorization can apply using a template provided by the FDA to share data on who the test is intended for and how well the test works, and provide instructions for its use...
The champion of legislation to give the Food and Drug Administration (FDA) regulatory power over mobile and wireless health apps, gadgets and other tools believes his plan is something industry wants and consumers need.
"The tech community needs confidence in a consistent, reliable framework for wireless health. The FDA has a critical role to play. Today, there is no confidence [among] industry....
