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Latest From Elizabeth Orr
Heart-pump manufacturer Abiomed has agreed to pay $3.1m to resolve allegations the company violated the US False Claims Act by spending lavishly on physicians.
US FDA is working with manufacturers, researchers and other stakeholders to assemble a comprehensive network of registries of cardiac device data. But cardiologists and device firms say the project faces multiple challenges.
A long-running shareholder case against Medtronic has come to an end after the US Supreme Court refused to hear the plaintiff's appeal.
A recent report from law firm Dechert LLP shows that the number of class-action cases brought against life-sciences companies has spiked in recent years, up from 27 in 2012 to 88 in 2017. The trend is most pronounced against smaller-cap companies, an attorney behind the report explains.
The US Federal Trade Commission hosted a sometimes-contentious discussion on proposed changes to its Contact Lens Rule on March 8. One issue up for debate was which methods are appropriate when a contact-lens seller needs to confirm a prescription with a patient's eye doctor.
On this week's podcast, we discuss US medtech policy developments from the Centers for Medicare and Medicaid Services, the Federal Trade Commission, FDA and the Supreme Court.