Regulatory Approvals

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...

An AI-powered, outcomes-driven, decision support tool – EchoGo Pro, has been cleared by the FDA and is now available to clinicians across the U.S.  EchoGo Pro...

Quanta Dialysis Technologies is bringing its small, lightweight blood purification system to the U.S., following its commercial launch in the U.K. last year and...

Spectrum Solutions has received CE Mark approval to sell and distribute its SDNA saliva collection devices to conduct IVD molecular diagnostic testing in Europe. Spectrum...

New Option will Provide an Efficient, Versatile and Cost-Effective Approach for Obtaining Exceptional Quality Images. Accuray Incorporated announced that the company has received 510(k)...

The US Food and Drug Administration (FDA) has approved the EndoRotor System (Interscope, Inc) for removal of necrotic tissue in patients with walled-off pancreatic necrosis (WOPN). "This...