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    Regulatory Approvals

    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)...

    FDA Clears Device to Remove Dead Pancreatic Tissue

    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...

    Medtronic gets FDA Clearance for Midas Rex™ Drills with Mazor™ Robotic System

    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...

    Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children

    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,...

    Respiratory Health company AireHealth lands 510(k) for connected nebulizer

    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...
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