FDA

Credit: NuvoAir

By Sara Mageit 04:41 am August 18, 2020
Sweden-based digital therapeutics respiratory company, NuvoAir, has been certified as a Class Im medical device. The NuvoAir Home platform includes Air Next, a certified bluetooth spirometer, a connected patient app and a healthcare portal.   WHY IT MATTERS Patients can use the platform to self-monitor their respiratory health and share clinically relevant data with their care teams, who can view...
By Dave Muoio 10:01 am August 6, 2020
Alongside yesterday's reveal of the Galaxy Watch3, Samsung announced that it has received regulatory clearance from the FDA for its ECG monitoring app. But while the watch – which also has built-in sensors enabling blood pressure and blood oxygen saturation – is slated for release on Aug. 6, the company did not say specifically when the new Samsung Health Monitor app that enables these features...
By Dave Muoio 02:15 pm July 27, 2020
On Friday evening, the FDA reissued an emergency use authorization (EUA) for LabCorp's COVID-19 RE-PCR Test that now allows for testing among those without any symptoms of COVID-19. The agency also expanded the indication to allow for pooled sample testing – a technique of combining multiple samples into a single test, and then following up with individual tests should the group be positive. The...
By Dave Muoio 02:56 pm July 24, 2020
Abbott has received FDA approval for a neuromodulation system-controller app that runs on iOS devices, the company announced Thursday. Compatible with Abbott's broader NeuroSphere Digital Care platform, the Patient Controller app replaces the separate device patients use to adjust the company's neuromodulation products. These include the Infinity DBS System for Parkinson's disease or essential...
By Mallory Hackett 03:22 pm July 16, 2020
Today the remote and continuous-monitoring platform Vitls announced that it has received 510(k) clearance from the FDA. The Vitls Platform uses a single wearable device called Tégo that records vital signs. The device itself is wireless and waterproof, and it has a battery life up to 6 days. It records body temperature, pulse, heart rate variability, respiration rate, oxygen saturation, sleep and...
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,...