The FDA recently cleared the TruDi Shaver Blade, an electromagnetically navigated blade for the incision and removal of soft and hard tissue or bone in ear, nose, throat, and maxillofacial surgery, as well as head and neck and skull-base surgery.
Acclarent, a Johnson & Johnson subsidiary, is applying precision sensor technology to ear, nose and throat (ENT) surgery to improve outcomes and reduce the need for repeat procedures.
The US Food and Drug Administration recently cleared Acclarent’s TruDi electromagnetically navigated shaver blade to be used with
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.
