With diagnostic companies facing supply chain issues and reagent shortages for COVID-19 tests, Finnish diagnostics company Mobidiag decided to take matters into its own hands. CEO Tuomas Tenkanen tells Medtech Insight how the company secured manufacturing capabilities in-house.
Finnish diagnostics firm Mobidiag Ltd. will launch COVID-19 tests across Europe, following receipt of EU approval for its Novodiag and Amplidiag molecular assays to detect the SARS-CoV-2 virus. The tests were made available earlier this year in Finland, Sweden and France under emergency authorization approvals.
The Amplidiag COVID-19 assay, based on high-throughput PCR technology, is for use in large hospital labs, while Novodiag is a...
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
