Time is of the essence when treating patients with advanced or metastatic cancer, and diagnostic insights can inform treatment plans. To that end, Exact Sciences Corp. has launched its Oncotype MAP Pan-Cancer Tissue test for patients with advanced, metastatic, refractory or recurrent cancer. From a small tissue sample, the test detects genomic alterations in hundreds of cancer-related genes, helping doctors better depict a patient’s tumor and recommend effective therapies or clinical trials. Read More
Two teams of researchers have developed miniature models of the human heart that beat and function like the full-size organ. The team from Michigan State University (MSU) and Washington University in St. Louis developed a human heart organoid (hHO) that recapitulates embryonic heart development, providing an unmatched view into congenital heart defects. The organoid created by the researchers at the Medical University of South Carolina (MUSC) and Clemson University mimics the tissue dysfunction that occurs following a heart attack. Read More
The U.S. FDA has several years of experience with computational modeling (CM) for medical device design and testing; however, the movement toward a policy has wanted for a solid body of data on which to base a guidance. Read More
NEW DELHI – India’s digital health market is poised to grow rapidly over the next five years propelled by the COVID-19 pandemic, according to two new reports. Read More
PARIS – A consortium that includes Therapanacea SAS, GE Healthcare France SAS, Orange Healthcare SA, the AP-HP group of 39 hospitals in the Paris region and the French academic society for thoracic imaging has created a database for COVID-19. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Livanova, Lunit, Masimo. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ac Immune, Alliance Family of Companies, Applied DNA Sciences, Battelle, Caretaker Medical, Cerner, Clinical Laserthermia Systems, Columbia University, DNA Labs International, Freedom Innovations, Haliodx, Induction, Medalliance, OSU Wexner Medical Center, Osmind, Ottobock, Pacific Edge, Paltown Development Foundation Proteor, Providence, Southwest Labs, Stratus, Tegria, Thermo Fisher Scientific, Votis. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian. Read More
Keeping you up to date on recent developments in cardiology, including: Complications in pregnancy tied to increased risk of heart disease, stroke later on; Creating an artificial vessel; Hearts in space! Read More
