Medical device company Linear Health Sciences announced it received an expanded indication from the U.S. Food & Drug Administration (FDA) for its Orchid SRV™ safety release valve. The expanded indication means that the Orchid SRV may now be used with all IV access methods.
American Regent announces the release and availability of Levocarnitine Injection, USP, FDA-approved, "AP" rated, and therapeutically equivalent to Carnitor®. Levocarnitine is indicated for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency, and for the prevention and treatment of carnitine deficiency in patients with end-stage renal disease who are undergoing dialysis.
ClariMed, Inc., the first end-to-end MedTech services partner to prioritize usability as the core of their integrated, human-centric approach to medical product development, announced the appointment of Sandrine Parkins as Head of Operations for Harvey Medical, a ClariMed company.
Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for indication expansion of the Quanta™ Dialysis System, a compact and easy-to-use hemodialysis device.
GT Molecular, Inc., a company providing ultrasensitive PCR assays for wastewater-based epidemiology testing, pathogen detection, and cancer research is pleased to announce an agreement with Roche to provide a highly multiplexed respiratory panel for wastewater surveillance on the new Roche Digital LightCycler® System.
Masimo announced the findings of a study published in Frontiers in Neuroscience in which Dr. Lichy Han and colleagues at Stanford University evaluated the ability of Masimo SedLine® brain function monitoring to assess the sedation levels of patients undergoing drug-induced sleep endoscopy (DISE) with dexmedetomidine – a sedative with numerous advantages.
HemoSonics®, a medical device technology company focused on acute bleeding management, announced its Quantra® Hemostasis System has received an Innovative Technology contract award from Vizient, Inc.
Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible,announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device.
XRP Healthcare and Spiritus Medical is thrilled to announce their strategic collaboration, set to transform the healthcare landscape in Africa. This groundbreaking partnership aims to bring cutting-edge medical technology to the region,starting with the integration of the SPIRITUS VITALITY Ventilator into newly acquired medical facilities in East Africa, with Uganda as the initial focus.
PacBio a leading developer of high-quality, highly accurate sequencing solutions, announced that customer shipments of Onso short-read sequencing instruments will commenc.