Regulatory Approvals

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System Endologix LLC, a privately held global medical device company dedicated to improving patients’...

MIGS Founder Leads with the First-Ever Micro-Invasive Implantable Device for Standalone Glaucoma Treatment Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused...

Ambu will extend market leadership in pulmonology by entering the bronchoscopy suite segment following U.S. and European market clearances. Ambu Inc. announces that Ambu® aScopeTM...

The Apthera extended depth of focus IOL uses proprietary small aperture technology to filter out peripheral defocused light, allowing only focused light to reach...

iRhythm Technologies (Nasdaq:IRTC) announced that it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system. ZEUS, produced in partnership with Google’s life sciences...

Nyxoah Announces CE Mark Approval for Genio® 2.1 The next generation external activation chip leverages Nyxoah’s scalable platform to continuously enhance patient comfort and therapy...

The system provides visual feedback regarding the location of the probe and reduces radiation exposure during surgery. Spinal instrumentation firm Waypoint Orthopedics has submitted an application seeking...

First Relief is placed behind the ear and provides continuous pulses of low-level electrical current. DyAnsys has received US Food and Drug Administration (FDA) approval for its...

At-home diagnostics have been a crucial weapon in the war against the COVID-19 pandemic, and after proving their mettle on that battlefield, they’re now...