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The recent extensions of MDR timelines have once again forced companies to recalculate their strategies for operating under the new regulations. Here a panel of CEOs and investors at our recent Dublin Innovation Summit share their perspectives on operating in this ever-changing environment.
Pulmonary embolisms are managed by blood thinners, anticoagulants, and thrombolytic drugs, which cannot always resolve the problem and entail their own risks for bleeding complications. In a market with few widely used treatment options, start-ups Althea Medical, Akura Medical, and Magneto Thrombectomy are giving surgeons new minimally invasive tools to remove clots more effectively than ever.
CDRH officials took to the journal Health Affairs to press Congress for more authority to require device firms to disclose supply chain disruptions to head off product shortages.