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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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