FDA Clears Getinge Edi Catheter
The FDA granted 510(k) clearance to Getinge's 6Fr/48 cm Edi catheter designed for premature infants weighing between 500 and 1,000 grams.
The FDA granted 510(k) clearance to Getinge's 6Fr/48 cm Edi catheter designed for premature infants weighing between 500 and 1,000 grams.
GE HealthCare issued updated use instructions for all Portrait Mobile Monitoring Solutions operating on certain versions of Portrait Core Services software, according to an FDA early alert.
Masimo received FDA 510(k) clearance for the Patient State Index (PSi) , a new monitoring index that helps clinicians track brain activity and sedation levels in children during surgery and intensive care.
The new portfolio includes smart monitoring and cueing devices designed to support proactive patient care and data-driven insights.
Baxter has recommended removal of certain Duo-Vent solution sets used for administration of fluids to the patient's vascular system.
Patients with long COVID receiving individualized cognitive rehab showed significantly higher goal attainment scores at three months compared to standard care.