US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance
The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.
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Troponin assays are routine tools for diagnosing heart attacks, but there have been challenges on the regulatory front, as testing standards evolve and technology rapidly improves. The agency has called a public meeting for late November to discuss scientific and regulatory challenges for troponin assays and more efficient development strategies.
While the in vitro diagnostics landscape has seen players come and go, Roche Diagnostics has remained at the top. But the Swiss giant, like all its other smaller rivals, is facing a new reality, with increasing pressures to prove medical value, and a more stringent regulatory environment. Medtech Insight spoke to Roche Diagnostics' Jean-Claude Gottraux, head of centralized and point of care solutions, and Jean-Jacques Palombo, lifecycle leader for the company's cardiac, women's health and personalized health care solutions immunoassay portfolio, to gain their perspectives on how the sector has evolved and will continue to evolve. They also spoke about the company's strategy to address these changes and challenges.
Biogen’s investigational anti-tau antibody gosuranemab has missed its primary efficacy endpoint in a Phase II study in patients with Alzheimer's disease, prompting the end of the trial and termination of the compound’s further clinical development.