Abbott Laboratories received FDA 510(k) clearance for the Ensite X EP system with Ensite omnipolar technology, the company’s cardiac mapping platform. The system, which is used to identify and treat abnormal heart rhythms such as atrial fibrillation, produces detailed three-dimensional maps of the heart to guide physicians performing ablation procedures. Read More
Illumina Inc. and Agendia NV are joining forces for a multiyear partnership to develop diagnostic tests for breast cancer. The collaboration will unite lllumina’s Miseq Dx sequencing platform, with Agendia's flagship genomic test, Mammaprint, which identifies a patient’s breast cancer recurrence risk. Illumina has been steadily signing partnerships over the past few years and currently has more than 30 IVD partners and 40 sequencing-based solutions for cancer under development. Read More
Point-of-care (POC) diagnostics startup Chronus Health Inc. reeled in $22 million in a series A round led by Tarsadia Investments. The company plans to use the funds to scale its research, engineering and data science teams and hasten product and technology development. Monta Vista Capital, Sosv and Savantus Ventures also participated in the financings, along with an unidentified strategic investor. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results. Read More
PARIS – The team from the ENT surgery department at Clermont-Ferrand University Hospital recently placed a cochlear implant into a patient with profound deafness using the Collin Medical SAS otologic robot in a hybrid operating room known as Imabloc. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Caredx, Castle Biosciences, Electrocore, Glaukos, Pictor. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Disior, Eurobio Scientific, Glytec, K'(Prime) Technologies, Nano-X Imaging, Nuvo Group, Orasure Technologies, Paragon 28, Roche Diagnostics, Unified Women's Healthcare. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Electrocore, Evolved by Nature. Read More
