More
    Guided Solutions - Connecting Talent With Innovation/div>

    Regulatory Approvals

    Imperative Care wins FDA nod for new Zoom 7X catheter

    Imperative Care received FDA 510(k) clearance for its novel Zoom 7X catheter for aspiration thrombectomy procedures. The company also reported the first patient cases with...

    Elekta wins expanded FDA nod for Gamma Knife radiosurgery system

    Elekta announced it received FDA 510(k) clearance to expand indications for its Leksell Gamma Knife radiosurgery system. The system’s cleared indications now include refractory, intractable...

    Spirair wins FDA nod for TurbAlign bioresorbable sinus surgery implant

    Spirair announced the FDA granted 510(k) clearance for its TurbAlign bioabsorbable implant device. The company designed the novel, bioabsorbable device to aid healing from sinus...

    UroMems awarded FDA IDE to use artificial urinary sphincter in pivotal trial

    UroMems is set to enter the pivotal trial phase with its device for treating stress urinary incontinence (SUI). The company was awarded an investigational device...

    FDA grants 510(k) clearance for Tempus AI’s ejection fraction software

    The US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI’s ECG-Low (ejection fraction) EF software. This software utilises AI to detect...

    Synchrony Medical wins FDA nod for airway clearance system

    Synchrony Medical received FDA 510(k) clearance for its LibAirty airway clearance system. LibAirty addresses a need for patients with chronic lung diseases such as chronic...

    Exactech wins FDA clearance for scapula reconstruction system

    The US Food and Drug Administration (FDA) has granted 510(k) clearance for Exactech’s Equinoxe scapula reconstruction system for treating acromial and scapular spine fractures. These...

    Caranx Medical surgical robot TaviPilot AI software wins FDA clearance

    The FDA has granted 510(k) clearance to the TaviPilot AI software developed by Caranx Medical, according to company officials. Pierre Berthet-Rayne, the company’s co-founder and...

    AIRS Medical earns expanded MDR Certification for AI-Powered MRI image enhancement solution SwiftMR

    AIRS Medical, a leader in AI solutions for diagnostic imaging, has received Medical Device Regulation (MDR) certification from the European Union (EU) for SwiftMR...
    1...121314...108Page 13 of 108

    Latest articles

    Popular articles

    Featured

    Newsletter

    [hubspot type=form portal=25601863 id=e07d0241-001f-4840-8c08-6e5a4f7af710]

    © Copyright - Guided Solutions - Global Executive Search in Medical Devices