AliveCor announces at the 4th annual mHealth Summit that its ECG iPhone case has received FDA 510K approval, shows evidence of its effectiveness.
Tag: FDA 510(k) Approval
c8 MediSensors and Dexcom, have received regulatory approvals for their Continuous Glucose Monitoring (CGM) systems in the EU and US
Canadian startup Segasist Technologies has launched a crowdfunding campaign on MedStartr to take its tumor imaging technology into the cloud.
Proteus Digital Health has received de novo FDA 510k clearance for its Ingestible Event Monitor medication adherence system after four year review.
Asthmapolis earns FDA 510k approval for its Spiroscout asthma symptom tracking device in little more than one month.