FDA

By Dave Muoio 09:45 am September 23, 2020
Cognoa, a digital health company developing software tools for children with autism and other behavioral health conditions and their families, signaled today that it will be moving ahead with a De Novo FDA regulatory submission for its digital autism spectrum disorder (ASD) diagnostic. The tool, which received a Breakthrough Device Designation from the agency in late 2018, is designed to help...
By Dave Muoio 04:00 pm September 22, 2020
The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the agency as well as external stakeholders promote digital health technologies. Housed within the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence (DHCE) will focus on a range of technologies "mobile health devices, Software as a Medical...
By Laura Lovett 03:16 pm September 17, 2020
For digital therapeutics companies, the FDA has often been viewed as the gatekeeper to getting products to the patients. However, today the conversation around efficacy and research is branching beyond just what ticks the FDA boxes, into what kinds of studies are needed to meet the expectations of stakeholders and end users. This morning at DTx East, a group of panelist discussed the current...
By Laura Lovett 02:49 pm September 15, 2020
Capsule Technologies, a medical device-maker (not to be confused with digital pharmacy Capsule), has just landed FDA 510(k) clearance for its new connected capnography-monitoring technology.  Called Vitals Plus monitoring solution, it was created to incorporate Masimo's NomoLine ISA CO2, and designed to keep track of a patient's end-tidal carbon dioxide, respiratory rate, and fractional inspired...
By Laura Lovett 03:03 pm August 31, 2020
Connected care company Masimo has landed and expanded FDA clearance for its O3 Regional Oximeter, for both somatic applications and monitoring changes in the cerebral hemoglobin.  It specifically monitors somatic tissue oxygenation saturation, and can detect changes in a patient’s hemoglobin, oxyhemoglobin and deoxyhemoglobin.  According to the company, its tool differs from peripheral pulse...

A product image of the existing AncestryHealth offering.

By Dave Muoio 03:15 pm August 24, 2020
Consumer genomics company Ancestry recently received two FDA 510(k)s – one for an in vitro molecular test that detects genomic variants tied to potential disease risk, and another for a saliva-based DNA specimen-collection kit. Both of these submissions were received by the FDA in October of last year, which officially cleared them on August 13, according to the agency's 510(k) database. Each was...
By Dave Muoio 03:03 pm August 18, 2020
23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing. WHAT HAPPENED This action updates a De Novo approval granted to the consumer genomics company in late 2018. That decision allowed 23andMe to market a test for one of 33...

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...