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    Regulatory Approvals

    Astellas subsidiary Iota wins FDA IDE nod to study implantable bladder device

    Iota Biosciences, a subsidiary of Astellas Pharma, announced that it received FDA investigational device exemption (IDE) for its bladder implant. The FDA gave the go-ahead...

    FDA clears Vy Spine’s 3D printed spinal fusion device

    Vy Spine has received clearance for its 3D printed LumiVy OsteoVy PEKK Lumbar IBF device from the US Food and Drug Administration (FDA). The device...

    FDA clears Regenity Biosciences’ regenerative meniscus implant

    Regenity Biosciences received FDA 510(k) clearance for its RejuvaKnee implant for soft tissue injuries of the meniscus. The minimally invasive, collagen-meniscal implant aids in...

    AccurKardia bags breakthrough designation for AI powered stenosis platform

    US-based electrocardiogram (ECG) company AccurKardia has received breakthrough designation from the US Food and Drug Administration (FDA) for its Aortic Valve Stenosis (AVS) ECG-based...

    FDA approves Happy Health’s medical-grade wearable smart ring

    Health technology company Happy Health has received approval from the US Food and Drug Administration (FDA) for its Happy Ring, a clinical-grade wearable smart...

    Corin wins FDA nod for Unity Knee tibial insert for robot-assisted TKA

    Corin received FDA 510(k) clearance for its Unity Knee medial constrained (MC) tibial insert. Cirencester, UK-based Corin designed the Unity Knee MC tibial insert...

    FDA greenlights OrthAlign’s handheld Lantern Hip navigation system

    OrthAlign has expanded its portfolio of Lantern handheld navigation systems by securing a 510(k) clearance from the US Food and Drug Administration (FDA) for...

    Positrigo announces CE mark for NeuroLF PET system

    Zurich-based nuclear medical imaging device firm Positrigo’s positron emission tomography (PET) system, NeuroLF, has acquired market authorisation from the European Union (EU). The ultra-compact diagnostic...

    FDA approves BioIntelliSense’s BioButton wearable for patient monitoring

    BioIntelliSense has received approval from the US Food and Drug Administration (FDA) for its BioButton Multi-Patient wearable and BioDashboard system for continuous patient monitoring. The...
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