The FDA has granted an Emergency Use Authorization (EUA) to VitalConnect that allows its VitalPatch wearable sensor to further monitor patients undergoing COVID-19 treatment.
As per the agency's letter of authorization, providers may use the remote-monitoring device in a hospital setting to spot changes in patients' QT interval, which may be dangerously prolonged by experimental drug treatments...
Following numerous reports of underperforming COVID-19 antibody tests, the FDA has raised the bar for these products in a revision to its emergency testing policy.
As of today, commercial manufacturers that notify the agency of their intent to submit a test for Emergency Use Authorization are required to do so within 10 business days from the date of notification. Further, the FDA has recommended...
Pear Therapeutics is rolling out its new digital therapeutic aimed at treating schizophrenia for limited distribution, after the FDA loosened up its regulations for digital psychiatric disorders devices during the coronavirus crisis.
The new tool, called Pear-004, uses multimodal neurobehavioral interventions combined with antipsychotic medications. Patients with schizophrenia can use the tool...
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
Many appreciate that telemedicine...
Less than a week after FDA opened the faucet for digital health products treating psychiatric conditions during the COVID-19 health crisis, Akili has fast-tracked and released its approval-pending digital therapeutic for children with ADHD.
Now known as Endeavor and flanked by a symptom tracker and caretaker support line, the video game-like app will be provided at no cost for a limited time to...
Thanks to an updated emergency use authorization (EUA) from the FDA, LabCorp's COVID-19 RT-PCR test is now the first diagnostic test for COVID-19 that permits at-home sample collection.
Now, patients may use Q-tip-style nasal cotton swabs and saline included in LabCorp's designated self-collection kit – which the company is branding as the "Pixel by LabCorp COVID-19 Test." These samples are...
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency.
"Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing,...
Easy access to (temporarily) free counseling. Consumer telehealth and mail-order prescription services Hims and Hers are dipping into the mental health wellness space. The brands kicked off new anonymized group therapy and guided meditation offerings yesterday, with the therapy sessions led by a licensed mental health practitioner.
The group sessions are currently being offered free of charge in...
From me to you. Employee-wellness company Wellable has acquired assets from fellow digital-wellness product-maker MeYou Health, the companies announced. While the terms of the deal were not disclosed, it does transfer ownership of MeYou's Daily Challenge product to Wellable. This program encourages healthy eating, physical activity, stress management and other behaviors through daily email and...
Earlier this week Cellex became the first company to gain an FDA Emergency Use Authorization for a serology test. The test was designed to identify specific antibodies in the blood linked to coronavirus, which means it can be used to identify past coronavirus infections.
Before this test, the products on the market were designed to detect or diagnose if someone currently has the virus. ...
