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.
Sensiotec launches the Virtual Medical Assistant UWB vital signs monitor featuring no patient contact with sensors, cuffs or pressure pads.
Sotera Wireless receives FDA 510k approval for its ViSi Mobile body area network technology.
Interview with Chris Berka, CEO of Advanced Brain Monitoring in regards to their products and receiving small Business Innovation Research grants.
A look at Echo Therapeutics, their products and commentary about the future of the company.
Delray Beach, FL-based medical device developer PositiveID’s iglucose system was approved by the US Food and Drug Administration for plug-and-play cloud-based SaaS diabetes management platform iglucose.
NYU-based BioSignal Group has submitted their microEEG system to the FDA for pre-market approval, sets a high standard for ambulatory EEG Bluetooth amplifier design.
Physician billionaire Patrick Soon-Shiong furthers his foray into the mobile sector with a new deal that is huge for the advancement of body area network devices.