Author name: Leonardo Arias

Last month’s FDA advisory committee meetings for therapies developed by Capricor Therapeutics and Replimune effectively illustrate the different outcomes for patients when the agency prioritizes specialization in its reviews.

The list tells providers what treatments will no longer need preapproval this October, part of UnitedHealthcare’s pledge to cull 30% of its much-maligned utilization management controls. The codes span a broad range of services.

Shoddy CMS oversight is to blame, and the agency needs to do better, the HHS Office of the Inspector General said. The CMS concurred.

Abbott said it will use the study results to secure FDA approval for the TactiFlex Duo catheter that offers both PFA and RF energy for tailoring treatment of atrial fibrillation.

Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.

Daniel Chojnowski, JHHP’s current CFO, will provide stability so that the Baltimore-area insurer can recruit full-time for its next chief executive, the company said.

The healthcare distributor said the incident affected a subset of customers in its oncology and medical-surgical businesses.

The dialysis provider has opted to settle a proposed class action lawsuit stemming from a data breach last year that impacted 2.7 million people.

The orthopedics specialist aims to launch a knee robot in late 2028, followed by a shoulder robot in 2029.

Medtronic will gain rights to distribute the Hong Kong-based company’s Sentire surgical robot in certain markets outside the U.S. alongside its own Hugo system.