FDA

By Dave Muoio 11:08 am June 26, 2020
London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for its C100 System, a bedside device to measure respiration rate via radar in adult patients up to four feet away. Circadia said in its announcement that the C100 system will be launching "immediately" in light of the high demand for respiratory-related illness management. The startup is aiming...
By Dave Muoio 03:15 pm June 24, 2020
FDA begins sharing patient's cancer drug experiences. The FDA's Oncology Center of Excellence has kicked off the first step of new pilot program that will increase the availability of patient-reported outcome data from cancer clinical trials. Project Patient Voice, as it's called, will start with making the data from a single trial accessible online while the agency solicits public feedback, but...
By Dave Muoio 05:39 pm June 15, 2020
After years of waiting, Akili Interactive has finally received FDA De Novo marketing authorization for EndeavorRx, its video-game digital therapeutic for children aged 8 to 12 years with ADHD. This is the first game-based therapeutic that the FDA has greenlit for any condition, the regulatory agency noted in its announcement. It is also the first authorization for Akili, which has a handful of...
By Dave Muoio 02:51 pm June 3, 2020
WellDoc's BlueStar chronic disease-management tool has picked up another 510(k) FDA clearance that will allow it to support adult Type 2 diabetes patients using long-acting basal insulin. The feature was announced by WellDoc this morning, but cleared by the agency in April, according to a listing on its website. The new capability takes the form of a new program within the prescription BlueStar...
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...