Page 4 - News

Abbott developed Triclip to enable surgeons to repair tricuspid valves that no longer close properly and therefore allow blood to leak back into the right atrium of the heart. Edwards Lifesciences won FDA approval for its transcatheter valve replacement device, Evoque, earlier this month.

J.P. Morgan analysts see “a place for both repair and replacement.”

On Tuesday, a panel of experts convened by the FDA will discuss whether the data on Triclip show it is a safe, effective option for valve repair.

Invitae has hired restructuring advisers as it explores strategic options, including a potential bankruptcy filing, the Wall Street Journal reported Monday, citing unnamed sources familiar with the matter.

The genetic testing company could file for bankruptcy within weeks, according to the Journal report.

Invitae is working to strengthen its balance sheet, and its board of directors formed a special committee focused on improving the company’s capital structure, a spokesperson told MedTech Dive

Patients with chronic back pain have traditionally received physical therapy and medication when they first present with symptoms. However, patients can stop responding to the interventions or suffer side effects and have poor long-term outcomes. The limitations of traditional options have created a need for new ways to manage low back pain, the leading cause of disability globally.

SCS is an established option for patients who continue to experience chronic back pain after surgery. The technology

Hemodiafiltration has existed since at least the early 1970s and has been linked to benefits including better cardiovascular stability and improved clearance of certain molecules. Fresenius added to the evidence 10 years ago with a clinical trial that reported a 30% reduced risk of all-cause mortality in people treated with hemodiafiltration.  

Use of the technique varies by geography. In 2017, more than one-quarter of hemodialysis patients were on hemodiafiltration in Europe, compared

The FDA has looked into pulse oximeter inaccuracy over the past several years, posting a warning in 2021 and holding an advisory panel meeting earlier this month. The agency has discussed the potential for results to be affected by factors including skin pigmentation and perfusion.

Masimo, a manufacturer of pulse oximeters, has worked to show if its devices suffer from biases. In its announcement, Masimo cited a 2023 study showing its RD Set device performed similarly in people with dark