Labeling Errors Lead To Class I Recall For Baxter Software
The US FDA has designated a software application recall from Baxter Healthcare as class I, the agency’s highest-risk category.
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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.
Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases
The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.
The US FDA has granted Investigational Device Exemption to Colorado life sciences company ZimVie for its cervical disc implant. The approval means the company can begin enrolling patients in a study to further evaluate the device.