US regulators gave the thumbs-up to the first COVID-19 test that pools patient samples to determine if any one of the individuals in the pool may be infected. Despite concerns such tests may be diluted and make it harder to detect the SARS-CoV-2 virus, the FDA says validation data shows it works.
Over the weekend the US Food and Drug Administration again authorized Quest Diagnostics Incorporated’s Quest SARS-CoV-2 rRT-PCR test, but this time the authorization is to run multiple tests together to see if a patient within a pool of patients has COVID-19. The agency says the new method should save testing resources and help get results faster.
The agency on 18 July announced it gave emergency use authorization (EUA) for the first COVID-19 diagnostics test that can...
Banking on new billing codes for remote services, PAVmed’s Veris Health is expanding its oncology remote monitoring platform with Ohio State’s cancer center and developing an implantable physiological monitor to provide clinicians with continuous insights between treatment visits.
C-suite executives from Stryker, Intuitive Surgical and Fresenius passed a mainly upbeat verdict on the Indian medtech market and industry.
After a slight delay in closing the deal, Zimmer now has Monogram in-house. For shareholders hoping for CVR payouts, the first one looks fairly achievable, the rest increasingly less so. The vagaries of FDA clearance and market performance offer significant challenges to the new robotics powerhouse.
Abbott CEO Robert Ford said the diagnostics segment – pressured this year by China’s VBP and DRG reforms – is showing early signs of recovery, while the company’s operations in the US, Europe, and Latin America continue to grow at a healthy pace.
Banking on new billing codes for remote services, PAVmed’s Veris Health is expanding its oncology remote monitoring platform with Ohio State’s cancer center and developing an implantable physiological monitor to provide clinicians with continuous insights between treatment visits.
C-suite executives from Stryker, Intuitive Surgical and Fresenius passed a mainly upbeat verdict on the Indian medtech market and industry.
Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.
