Brian Bossetta

Intuitive will soon start rolling out more than 100 updates and user experience improvements to its da Vinci 5 surgical robot. The innovations to the already advanced robotic system include expanded visibility, enhanced communications, remote capabilities and improvements to its simulation platform.

Insulet is recalling millions of Omnipod pump patches due to a manufacturing issue that can result in patients not receiving adequate doses of insulin. The company reports 24 serious adverse events associated with the recall, which is the second recall of the devices this year.

KayserBetten is recalling pediatric care beds marketed in the US due to a potential hazard from the lock on the hand controls. If not properly locked, there's an increased risk of a child becoming trapped under the bed frame.

The FDA has issued a third early alert for Abiomed in as many weeks, this time over thrombus risk in 14Fr Low Profile Introducer Kits used with the Impella CP heart pump.

The FDA says its new webpage is dedicated to the device center's efforts to promote real-world data to generate real-world evidence. The agency says these data will enhance its regulatory decision-making process by providing a better understanding of real-world clinical outcomes.

Companion bills pending in Congress would reform how Medicare reimburses clinical diagnostic laboratory tests. If enacted, the RESULTS Act would fix flaws in the current framework, mainly Medicare's exclusion of smaller providers in establishing rates.

The FDA has issued an early alert for coaxial breathing circuit sets used with three Hamilton ventilator models, prompting a field correction to the devices' instructions for use. The company is reporting four serious injuries linked to the issue.

Stakeholders overwhelmingly oppose CMS proposals to repeal the NTAP and TPT alternate pathways for FDA breakthrough devices, warning the move would hinder hospital adoption and patient access. A separate proposal to create three new MS-DRG codes for complex spinal fusion has drawn broad support.

In a unanimous vote across party lines, the House Appropriations Committee agreed to cut off funds going to WISeR, a model that uses AI to conduct prior authorizations of Medicare claims. Senate Democrats are also trying to kill the model, which has already been implemented in six states.

Swedish medical technology firm Surgical Science offered this journalist the opportunity to test out its portable surgical simulator, which the company's CEO believes will revolutionize how surgeons perfect their craft.