Companion diagnostics
May 01, 2025
Medtronic Receives FDA Approval for OmniaSecure™ Lumenless Defibrillation Lead and Presents Positive Clinical Trial Results for Hugo™ Robotic-Assisted Surgery System; Roche’s AI Companion Diagnostic for NSCLC Earns FDA Breakthrough Device Designation; Boston Scientific Announces Positive 12-Month Phase 2 Results from ADVANTAGE AF Trial of FARAPULSE™ PFA System; Bausch Health Launches Fraxel FTX™ to Advance Skin Rejuvenation Treatments; Gestalt Diagnostics Secures $7.5M in Series A to Scale AI Pathology Solutions
Medtronic Received FDA Approval for Smallest-Diameter, Lumenless Defibrillation Lead, the Omniasecure™ Lead and Published Investigational Clinical Study Results, Offering New Therapy Option for Heart Rhythm Disorders On April 25, 2025, Medtronic plc., a global leader in healthcare technology, received U.S....
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Jan 23, 2025
Tempus Launches FDA-Approved xT CDx Test Nationwide; B. Braun Enhances Catheter Securement with the Launch of Clik-FIX; Illuccix® Secures European Regulatory Approval; FDA Clears CapsoCam Plus® for Remote Ingestion; BellaSeno Marks Success in Two Clinical Trials for Revolutionary Breast Implant Technology; AF Symposium to Feature Conformal Medical’s Groundbreaking GLACE Study
Tempus Announced the National Launch of the FDA-Approved xT CDx Test On January 15, 2025, Tempus AI, Inc., a technology company driving the use of AI to advance precision medicine and improve patient care, announced the nationwide launch of its FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Th...
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Nov 09, 2023
SIBIONICS’s Ground-breaking GS1 Continuous Glucose Monitoring System; Abbott’s HPV Test to Run on Alinity m; CleanNA’s CE-IVD Molecular Diagnostics Product; Orthofix’s WaveForm L Interbody System; Alucent Biomedical’s AlucentNVS Technology; Surmodics’s TRANSCEND Trial Data
SIBIONICS Received CE Mark for Its Ground-breaking GS1 Continuous Glucose Monitoring System On November 01, 2023, SIBIONICS, the world's third-largest Continuous Glucose Monitoring System (CGM) brand, received the CE Mark for its revolutionary GS1 CGM. This significant milestone marks a momentous achiev...
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Dec 22, 2022
Medtronic’s Hugo Robotic-Assisted Surgery System Trial; Insightec’s Pivotal LIBERATE Clinical Trial; FDA Granted EMA for Thermo Fisher Scientific’s Monkeypox Test; Life Spine’s Trulift Lateral Expandable Spacer System & Lateral Pate System; Fujifilm & Inspirata Announces Asset Purchase Agreement; Abbott Launched SCS System for Chronic Pain
Medtronic Announced First Patient Enrolment for Hugo™ Robotic-Assisted Surgery System in US Clinical Trial On December 15, 2022, Medtronic, a global healthcare technology leader, announced that the first patient was enrolled in the Expand URO US clinical trial for the Hugo™ robotic-assisted surgery...
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Sep 28, 2018
Companion Diagnostics
Companion diagnostics domain falls within the larger field of study called pharmacogenomics, which employs the person’s genomic makeup to predict a drug response or to tailor therapy specifically for that patient. The US FDA depicts companion diagnostics as an in vitro diagnostic device or an imaging tool, which pro...
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