Tag: FDA clearance
Cochlear Receives FDA Clearance for its Innovative Osia 2 Hearing Implant System
Cochlear, a leading implantable hearing devices manufacturer, received FDA clearance of its Osia® 2 System. The Osia System is the world's first active osseointegrated...
FDA Authorizes Tandem’s Interoperable, Automated Insulin Dosing Controller
Tandem Diabetes Care, a San Diego, CA-based insulin delivery and diabetes technology company, announced U.S. Food and Drug Administration (FDA) clearance of the company’s...
etectRx Receives FDA Clearance for its Ingestible ID-Cap System
etectRx, a digital health company based in Florida, received U.S. FDA 501(k) clearance of its breakthrough patented ingestible event marker, the ID-Cap System.
The ID-Cap...
AliveCor Raises $5.8 Million in New Funds, SEC Filing Reveals
Mobile ECG maker AliveCor has raised $5.78 million in new funds, according to an SEC filing. First spotted by Exits & Outcomes’ Brian Dolan,...
Dexcom Receives FDA Clearance for Dexcom G6 Pro Continuous Glucose Monitor
Dexcom, a maker of continuous glucose monitoring systems for diabetes management, received FDA clearance of its Dexcom G6 Pro Continuous Glucose Monitoring (CGM) System...
Biobeat’s Wearable Blood Pressure Monitors Receive FDA 501K Clearance
Biobeat, an Israeli bio-medical technology company received FDA 501K clearance for its patch and smartwatch for measurement of blood pressure, oxygenation and heart rate...