NIPRO Receives US FDA Clearance for ELISIO-HX Dialyzer
ELISIO-HX dialyzer, featuring NIPRO’s proprietary membrane technology, enhances middle molecule removal while remaining fully compatible with routine hemodialysis practice.
ELISIO-HX dialyzer, featuring NIPRO’s proprietary membrane technology, enhances middle molecule removal while remaining fully compatible with routine hemodialysis practice.
Johnson & Johnson plans a phased commercial rollout of the OTTAVA system with select customers in the United States while working in parallel to advance into additional indications.
Roche’s new PCR test simultaneously detects organisms associated with Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample.
Philips said the FDA-cleared reusable SpO₂ clip sensor will be introduced in select global markets later this year.
Johnson & Johnson’s dual energy catheter ablation platform gives physicians the flexibility to choose either radiofrequency or pulsed field energy based on patient anatomy and case complexity.
The clearance marks Movmedix’s entry into the US market and the beginning of a broader regulatory roadmap.
Last month, Ascletis received US FDA IND clearance to initiate a Phase I clinical trial evaluating its once-monthly Self-Assembling Lipid Depot (SALD) formulation of ASC35 as a subcutaneous treatment for obesity.
Roche has announced that the US Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) as a potential treatment for thyroid eye disease (TED). TED, also known as Graves’ ophthalmopathy, is a rare autoimmune inflammatory disease that affects the area around the eyes […]
Kowa’s selective PPARα modulator “K-808” (pemafibrate) has been granted “breakthrough therapy” designation by the US FDA for the treatment of primary biliary cholangitis.
Penumbra says THUNDERBOLT is currently the only computer-assisted vacuum thrombectomy (CAVT) device available in the US for stroke treatment.