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FDA Clears Informed Vital Core App for Contactless Pulse Measure

Summary: Mindset Medical has received FDA 510(k) clearance for its Informed Vital Core (IVC) App,...

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Natus Medical Submits FDA 510(k) for Point-of-Care EEG Device

Natus Medical submitted an FDA 510(k) notification for its point-of-care EEG device, designed to identify seizures in acute care settings.

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Diality Receives FDA Clearance for Moda-flx Hemodialysis System

Diality has received U.S. FDA 510(k) clearance for its Moda-flx Hemodialysis System, designed to support various dialysis treatments and improve usability across multiple care settings.

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FDA Clears Informed Vital Core App for Contactless Pulse Measure

Summary: Mindset Medical has received FDA 510(k) clearance for its Informed Vital Core (IVC) App,...

Clario Nabs FDA Clearance for SpiroSphere with Wireless ECG

Jun 14, 2024

Clario’s SpiroSphere platform received U.S. FDA clearance for its wireless COR-12 ECG device, consolidating spirometry and ECG data collection.

Siemens Healthineers Biograph Trinion Receives FDA Clearance

Jun 10, 2024

Siemens Healthineers received FDA clearance for its Biograph Trinion PET/CT scanner, which offers improved performance and efficiency.

FDA OKs InnoVoyce VYLO Laser System

May 31, 2024

InnoVoyce has received FDA 510(k) clearance for the VYLO Laser System, a 455nm blue light laser offering up to 30 watts of power.

Inspira Technologies Nabs FDA Clearance for Oxygenation System

May 28, 2024

Inspira Technologies has received FDA 510(k) class II clearance for its Inspira Art100 cardiopulmonary bypass system, which elevates patient oxygen levels quickly and may reduce the need for mechanical ventilation.