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St. Jude Medical's $271 million third-quarter revenue from implantable cardioverter-defibrillators (ICDs) suggests "it not only retained the two market share points it gained from the competition last quarter but it also modestly advanced," Lazard Capital Markets analyst Alexander Arrow said Oct. 19.
Every devicemaker should include a reimbursement strategy in the early stages of device development to ensure the viability of its products, experts said Oct. 18 at the annual Regulatory Affairs Professionals Society conference.
A U.S. appeals court ruled Oct. 16 in favor of German firm Schering AG's U.S. affiliate Medrad in a patent case against Tyco Healthcare Group and three co-defending firms.
Medtronic said Oct. 19 it will begin the largest-ever clinical trial to assess the safety of its Endeavor drug-eluting coronary stent in comparison with a competitor's device.
A nonprofit called Oct. 12 for a criminal investigation into Mentor's "apparent failure" to send the FDA data that showed safety problems with its silicone gel implants.
AdvaMed President and CEO Stephen Ubl expressed his appreciation Oct. 17 the "swift response" by HHS' Office of Inspector General (OIG) to a recent AdvaMed request for guidance from the agency on certain physician investment interests in device firms and distributors.
Lester Crawford, the former FDA commissioner who abruptly left the agency two months after being confirmed, pleaded guilty to failing to disclose financial conflicts and making false statements, but is unlikely to spend more than a few months in prison, his attorney says.