Regulatory Approvals

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...

The Mazor™ platform now provides surgeons with unprecedented procedural integration. Global leader in medical technology, Medtronic plc, has announced that the U.S. Food and Drug Administration...

Collaboration with Phonak brings breakthrough Marvel hearing technology to adult and pediatric cochlear implant wearers. Advanced Bionics (AB), a global leader in cochlear implant technology,...

The nebulizer called VitalMed is able to connect to a corresponding app designed to help patients track their symptoms. AireHealth, a Floridian startup focused on...

FDA Breakthrough Device Designations made in November included a sleep apnoea treatment to rival the CPAP machine and a neurostimulation migraine treatment The previous month...