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MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the U.S. Food and Drug Administration’s (FDA) De Novo granting for Onkos Surgical’s antibacterial coating for tumor and revision orthopedic implants.

Insulet Corporation announced it has received CE mark approval under the European Medical Device Regulation for the added compatibility of the Abbott FreeStyle Libre 2 Plus sensor with Insulet’s Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with type 1 diabetes.

Tandem Diabetes Care’s t:slim X2 ™ Insulin Pump is the First Automated Insulin Delivery System to Integrate with Abbott’s New FreeStyle Libre ® 2 Plus Sensor.

MedGenome, a global partner for comprehensive multiomics solutions, in collaboration with PacBio, is pleased to announce Dr. Lauren Esposito of the California Academy of Sciences as the recipient of the ‘2024 de novo genome assembly and annotation grant’.

Echosens announced the appointment of Victor de Lédinghen, MD PhD, as the company’s new Chief Medical Officer.

Injectsense Inc., a sensor-enabled digital health company, announced that the ethics committee at the Centro de la Vision Clinic in Santiago, Chile, has approved a 20-patient study that will confirm safety and effectiveness of the company’s ultra-miniature wireless pressure sensor, designed to continuously measure intra-ocular pressure (IOP) for glaucoma.

Onkos Surgical, an orthopaedic company founded to address the complex clinical challenges associated with bone loss due to tumor, trauma, and revision surgery, announced that the U.S. Food & Drug Administration (FDA) granted the company a De Novo approval for its novel antibacterial coated implants.

Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) for its first in vitro diagnostic Key Proteo Newborn Screening Kit.