Regulatory Approvals

Eitan Medical announced that it received European Union Medical Device Recognition (MDR) certification for its Sapphire infusion pump. Approval for the Sapphire infusion pump, along with...

Ready for commercial distribution, the first single-sided MRI, cleared for office setting, will be available in the United States. The United States Food and Drug...

The system delivers its results to a companion app in about 20 minutes, according to the agency. The FDA has issued its first emergency use...

Neurolief, an innovator in neurotechnology, announces the company has received Food and Drug Administration (FDA) clearance for its Relivion® system. Relivion® is the first non-invasive...

Shortly after TransEnterix changed its name to Asensus Surgical late last month—calling the rebranding a signal of its plans to bring artificial intelligence to...

The FDA cleared its first surgical robot designed for transvaginal hysterectomies, a minimally invasive option that aims for a faster recovery time compared to...

Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting...

The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson's Covid-19 vaccine outweigh its risks. FDA emergency use authorization...

Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption...