Regulatory Approvals

The rise of SkyWalker: FDA clears surgical robot for orthopedic procedures

Not so long ago in our very own galaxy, the FDA saw fit to expand its list of authorized robotic surgery systems—no epic interplanetary...

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System

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’...

Glaukos Announces FDA 510(k) Clearance of iStent infinite®

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 Announces FDA Clearance of Fifth-Generation Single-Use Bronchoscope

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...

AcuFocus Announces FDA Approval for the IC-8® Apthera™ Intraocular Lens, the First and Only Small Aperture Lens for Cataract Surgery

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

FDA clears iRhythm’s ZEUS system for Zio Watch

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

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...

Waypoint Orthopedics seeks FDA 510(k) approval for smart bone awl

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...

DyAnsys receives US FDA approval for First Relief neurostimulation device

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...
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