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Technology & Devices

FDA Grants Breakthrough Device Designation to Caris Life Sciences’ MI Transcriptome Companion Diagnostic Test

IRVING, Texas, May 3, 2019 /PRNewswire/ — Caris Life Sciences®, a leading innovator in molecular science focused on precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s MI Transcriptome™ companion diagnostic (CDx) test. Designed to detect gene fusions in …

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Presage and Celgene Collaborate to Investigate Novel Agents with CIVO Technology

SEATTLE, May 2, 2019 /PRNewswire/ — Presage Biosciences, a cancer biotechnology company pioneering a new cancer drug development approach using its CIVO™ intratumoral microdosing platform, today announced it has entered into a research collaboration with Celgene Corporation to evaluate several of Celgene’s early stage assets in Phase 0 trials. Presage’s CIVO platform is …

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FDA Grants Breakthrough Device Designation to KidneyIntelX, AI-Enabled Diagnostic for Kidney Disease

NEW YORK, May 2, 2019 /PRNewswire/ — Renalytix AI plc (LON: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such …

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Myriad Announces that EndoPredict Predicts the Chemotherapy Benefit in Women with ER-Positive, HER2-Negative Breast Cancer

SALT LAKE CITY, April 30, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced an international team of cancer researchers has found that EndoPredict® test accurately predicts which women with ER-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy.  Findings from the study …

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AstraZeneca and BenevolentAI Partner to use Artificial Intelligence and Machine Learning for Development of New CKD and IPF Treatments

AstraZeneca and BenevolentAI today began a long-term collaboration to use artificial intelligence (AI) and machine learning for the discovery and development of new treatments for chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF). Scientists from the two organisations will work side-by-side to combine AstraZeneca’s genomics, chemistry and clinical data …

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Calixar Signs Exclusive Licensing Agreement with Regeneron for Rights to its Technology for Antibody Discovery

Lyon, France, April 29, 2019 – Calixar SAS (Calixar), a biotechnology company specialized in native membrane protein stabilization, announces today that it has entered into an exclusive licensing agreement with Regeneron Pharmaceuticals, Inc. Under the terms of the agreement, Calixar has given Regeneron exclusive rights to its technology and expertise …

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New Genetic Test Detects Hundreds of Harmful Mutations Among High-Risk Groups

WILMINGTON, Del. (April 25, 2019) – Researchers at Nemours Children’s Health System have developed a new low-cost genetic test that accurately identified more than 200 known disease-causing gene variations in two high-risk populations, the Old Order Amish and Old Order Mennonites of Lancaster County, Pennsylvania. The findings, published today in …

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Daiichi Sankyo Selects Lead Candidate Built on Zymeworks’ Azymetric Bispecific Platform

VANCOUVER, British Columbia VANCOUVER, British Columbia & TOKYO & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) announced today that Daiichi Sankyo has exercised its option for a commercial license to a proprietary immuno-oncology bispecific built on …

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Macrogen and Exosome Plus to Jointly Develop Exosome-based Diagnostic and Treatment Solutions

SEOUL, South Korea–(BUSINESS WIRE)–The precision medicine and biotechnology company Macrogen (CEO Kap-Seok Yang, www.macrogen.com/en/) announced on April 24 that it had signed a supply contract with Exosome Plus (CEO Jong-Uk Bu, www.exosomeplus.com) on April 19 to become the exclusive buyer of the exosome isolation kits developed by Exosome Plus. The two companies also signed an MOU …

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FDA Permits Marketing of First Medical Device for Treatment of Attention Deficit Hyperactivity Disorder

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication …

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