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    Regulatory Approvals

    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...

    Five breakthrough device designations granted by the FDA in November

    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...

    AliveCor gets FDA clearance for algorithms to detect more cardiac conditions

    The startup, which has developed a portable ECG device, received clearance for algorithms to detect more cardiac conditions, such as premature contractions. As more companies...

    Braid Health gets FDA approval for AI-powered diagnostic platform

    Braid Health has made sure about FDA clearance for its AI-fueled diagnostic collaboration programming, improving diagnostic access and decreasing expenses for huge healthcare frameworks,...
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