News We’re Watching: Medtronic Kickbacks Case, BARDA Contract For Cue, Imeka Neuroimaging Software Cleared
This week, a court ordered a Medtronic whistleblower to hand over records of his media contacts; Cue Health was awarded $28m to develop a multi-disease respiratory panel; and the FDA granted a zero fluoroscopy Indication to some Biosense Webster cardiac ablation devices.
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Almost 800 devices have been granted priority status through the US FDA’s breakthrough devices program, the agency announced this week. But device clearance numbers continue to lag, with only 67 granted as of 31 March.
FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.
News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’
This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.