Lightpoint Medical Receives CE Mark for World’s First Approved Robotic Gamma Probe
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...
DePuy Synthes Receives 510(k) FDA Clearance for VELYS™
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. Receives CE Mark for Diamondback 360® Coronary Orbital Atherectomy System
Cardiovascular Systems, Inc. a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today...
FDA clears Cios Flow mobile C-arm system from Siemens Healthineers
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...
Cognito Therapeutics nets FDA breakthrough label for light, sound therapy for Alzheimer’s disease
- 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...
AI decision support tool receives FDA clearance
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 nets FDA clearance for its portable dialysis system
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 obtains CE Mark for saliva collection devices
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...
Accuray Receives 510(k) FDA Clearance for ClearRT™ Helical kVCT Imaging for the Radixact® Treatment Delivery System
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)...