A jury recommended a $70m award to Edwards Lifesciences unit CardiAQ based on findings that another firm, Neovasc, breached a supplier contract and used CardiAQ's trade secrets to develop a competing transcatheter mitral valve device.
A jury in Boston has recommended that Neovasc Inc. pay Edwards Lifesciences Corp. subsidiary CardiAQ Valve Technologies Inc. $70m in damages to resolve a two-year old lawsuit, Edwards announced May 19.
The jury in the United States District Court for the District Of Massachusetts said Neovasc breached a nondisclosure agreement while...
Create an account to read this article
Already a subscriber?
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.
The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.
