Biocartis Group NV received CE-marking of its Idylla Gene Fusion lung cancer biomarker test. The automated panel is designed to detect chromosomal translocations that generate fusion genes and cause non-small-lung cancer (NSCLC). Mechelen, Belgium-based diagnostics company Biocartis recently reported results from a study that found the assay enables rapid screening with quicker turnaround and lower tissue requirements compared to standard methods. Read More
Prognomiq Inc. secured access to 800,000 anonymized biological samples for analysis and detection of dynamic cancer biomarkers as part of a new partnership struck with Kahn-Sagol-Maccabi (KSM), the research and innovation center of Maccabi Healthcare Services, Israel’s largest health maintenance organization. The partnership will enable the creation of a biomarker platform the organizations hope will facilitate early diagnosis and improved outcomes for cancer patients using Prognomiq’s multiomics platform. Read More
Medical device supply chain considerations became especially salient during the COVID-19 pandemic, but the U.S. FDA is interested in ensuring that supply chains do not hamper patient access going forward. However, Clayton Hall of the Medical Device Manufacturers Association (MDMA) said on a recent FDA webinar that device makers are sometimes at the mercy of their suppliers. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) had covered transcarotid artery revascularization for patients at high risk of poor outcomes during carotid artery endarterectomy to correct for stenosis, but the agency recently expanded that patient population to those at standard surgical risk. The news was lauded by the Society for Vascular Surgery (SVS) as a solid development for patients, given that this procedure’s complication rates are in many instances lower than seen in conventional endarterectomy. Read More
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye. Read More
While the World Trade Organization (WTO) is taking a victory lap for getting a five-year intellectual property (IP) waiver across the finish line for COVID-19 vaccines, the accomplishment is being panned by spectators on both sides of the track. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Access, Avania, Bausch Health, Blackrock Neurotech, Bone Health, Choicespine, Densitas, Ecential Robotics, Exact, Kailo Medical, Quipt, Ultima, Zeus. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Protondx. Read More
