Regulatory Approvals

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it...

Organon (NYSE: OGN), a global women’s health company, announced clearance by the U.S. Food and Drug Administration (FDA) of the Special 510(k) for technological...

The system uses virtual reality and an AI-backed tool. SyncThink landed FDA clearance for its digital AI-backed system, called the EYE-SYNC, to be used as...

iotaMotion has announced FDA granted its De Novo classification request to market the iotaSOFT™ insertion system. iotaSOFT is the world’s first and only robotic-assisted insertion...

Laboratory Corporation of America said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a combined...

FDA has granted 510(k) clearance to a Siemens Healthineers' diagnostic imaging device designed to boost the spatial resolution of computed tomography while reducing the dose.The product, which FDA...

Providers can use SimpleSense to remotely triage cardio, pulmonary and upper vascular patients. Nanowear, a remote diagnostics and smart clothing company, has added another Food...

The FDA has cleared a next-generation system to continuously monitor patients’ blood pressure while they’re undergoing surgery without the use of inflatable cuffs or invasive...

Dayspring Lite is the latest addition to Koya’s suite of treatment options for lymphedema and venous disease, a condition impacting 20 million Americans. Koya Medical,...