Regulatory Approvals

The eXciteOSA strengthens tongue muscles through electrical stimulation and comes with a companion app for tracking and sharing progress. The FDA has granted De Novo...

Abbott has received the CE mark for two new uses of its Panbio COVID-19 Ag Rapid Test Device for the detection of the SARS-CoV-2 virus:...

Aktiia has received a CE mark for its automated blood pressure monitoring system, which the company says is the first of its kind. The Class...

OrthoSpin was granted FDA 510(k) clearance to market a next-generation robotic digitally-enabled external fixation system. The OrthoSpin G2 system is approved in Israel as well, and can...

Lightpoint Medical, a medical device company developing miniaturized surgical tools for advanced intra-operative cancer detection, announced today that it has received CE Mark approval...

The VELYS™ Robotic-Assisted Solution is adaptable technology that helps simplify surgeons’ existing workflow, and is designed around how surgeons plan, execute and perform surgery...

Cardiovascular Systems, Inc. a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today...

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the Cios Flow, a mobile C-arm designed for use by multiple disciplines...

- Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation digital therapeutic to treat memory and...