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Linked to high mortality rates, current treatment options for tricuspid regurgitation remain extremely limited.
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The FDA has authorised the company to begin a US myomectomy trial through an investigational device exemption.
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Whoop noted that alongside Abbott, the company's share a mutual interest in "empowering people to take control of their health".
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Lumitrace is currently approved in China and the US, with submission to EU regulatory authorities pending.
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The FDA’s HDI makes Serenity’s River the first stent approved for severe idiopathic intracranial hypertension treatment.
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