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Op-Ed: Medicare Needs to OK Rule Giving Seniors Access to FDA-Approved Medical Devices

Unlike drugs, which are typically covered by CMS immediately upon FDA approval, seniors can t access many FDA approved or cleared medical diagnostics and devices unless they can participate in a clinical study sanctioned by CMS. Those studies can take years requiring additional data and a lengthy regulatory process to determine coverage criteria and keep potentially lifesaving medical interventions from Medicare beneficiaries in the meantime. A new policy that was set to take effect in mid-March would have allowed seniors and their doctors decide whether or not they need those devices, but it was put on hold along with other pending regulations when the Biden administration took office. The proposed Medicare Coverage of Innovative Technology policy, which was delayed until May 15 pending regulatory review, leverages existing FDA legal authority through the Breakthrough Devices Program to identify a limited number of promising medical technologies and offers those products a shor

Perimeter Medical Imaging AI Reports 2020 Financial Results and Provides Corporate Update

Perimeter Medical Imaging AI Reports 2020 Financial Results and Provides Corporate Update Perimeter Medical Imaging AI, Inc. a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, today reported financial results for the year ended December 31, 2020 and provided a corporate update. Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, “In 2020, we achieved a number of key milestones, … Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Company”), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, today reported financial results for the year ended December 31, 2020 and provided a corporate update.

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