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Biotech Bay
Injectsense First-in-Human Glaucoma Device Study Approved by Ethics Committee at Centro de la Vision Clinic
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.
May 6, 2024
·
4 min read
Press Releases
SONOMOTION ANNOUNCES FDA DE NOVO CLEARANCE FOR ITS STONE CLEAR™ DEVICE
November 13, 2024
·
2 min read
Press Releases
Colossal Achieves Multiple Scientific Firsts in Progress Towards Thylacine De-Extinction
October 17, 2024
·
11 min read
BioCapital
MCRA Supports Onkos Surgical with First FDA De Novo Approval for Antibacterial Coating for Implants
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.
June 20, 2024
·
4 min read
Press Releases
FDA Grants De Novo Marketing Authorization for the Distalmotion Dexter® Surgical Robot
October 28, 2024
·
5 min read
Business
Echosens Appoints Dr. Victor De Lédinghen as Chief Medical Officer
Echosens announced the appointment of Victor de Lédinghen, MD PhD, as the company’s new Chief Medical Officer.
March 26, 2024
·
2 min read
Biotech Bay
MedGenome announces de novo Genome Assembly and Annotation Grant winners for 2024
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’.
May 2, 2024
·
4 min read
Press Releases
Peytant Solutions, Inc. Granted FDA De Novo for AMStent® Tracheobronchial Covered Stent System
October 22, 2024
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2 min read
Press Releases
ClearPoint Neuro Announces FDA De Novo Marketing Authorization of SmartFlow Cannula for Direct Delivery of Gene Therapy to the Brain
November 14, 2024
·
7 min read
Press Releases
FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
November 14, 2024
·
5 min read
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