FDA

By Dave Muoio 03:19 pm May 26, 2020
Digital respiratory health company Propeller Health has received 510(k) clearance for a sensor and app intended for use with AstraZeneca's Symbicort inhaler for asthma and COPD, the company announced today. The tool – which, according to the agency, was submitted to the agency in September and greenlit in late March – was developed in a previously unannounced partnership with the Cambridge,...
By Dave Muoio 11:40 am May 19, 2020
Austin, Texas-based EverlyWell, a digital platform that lets consumers order lab tests online and view their results, has received an FDA Emergency Use Authorization (EUA) for a COVID-19 at-home diagnostic sample collection kit that can be used with multiple diagnostic lab tests. Announced Friday by the FDA and Monday by the startup, the EverlyWell COVID-19 Test Home Collection Kit includes nasal...
By Laura Lovett 03:53 pm May 14, 2020
Early this week cardiac-focused digital health company Eko scored a temporary Emergency Use Authorization (EUA) for its ECG low ejection fraction tool, which can be used to help clinicians spot cardiac complications associated with the novel coronavirus. Providers are able to use the tool in order to get an assessment of Left Ventricular Ejection Fraction, a measure which providers can use to...
By Laura Lovett 04:03 pm May 8, 2020
Just a few hours ago the FDA greenlighted the first home-collected saliva sample for COVID-19. Rutgers Clinical Genomics Laboratory, which already landed an EUA in mid-April for its test, can now expand its efforts to include test kits for home collection. Patients do so using a specially designed collection device. This sample is then sent off to the Rutgers Clinical Genomics Laboratory in a...
By Laura Lovett 02:00 pm May 6, 2020
This morning the FDA granted Australian company Headsafe a 510(k) clearance for its connected headgear that is able to perform an assessment of the brain.  Named Nurochek, the system uses Visual Evoked Potential (VEP) in order to gauge brain health. When a user puts on the headgear, which includes a set of goggles, the system presents visual stimulus to the brain. As this process is taking place...
By Dave Muoio 03:28 pm May 5, 2020
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...
By Dave Muoio 03:43 pm May 4, 2020
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...
By Laura Lovett 04:18 pm April 29, 2020
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...
By Bradley Merrill Thompson 03:46 pm April 24, 2020
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...
By Dave Muoio 06:00 am April 22, 2020
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...