Brian Bossetta

SS Innovations is confident that the track record of its Mantra robotic system will result in an FDA clearance sometime this year. The company is also seeking the CE mark for Mantra, which has already been cleared for use in 11 countries. The company's CEO discusses the robotic system.

During his 13 months running the US FDA, Marty Makary accelerated reviews, brought AI to the agency, and presided over smooth and speedy MDUFA negotiations. However, his tenure was also marked by internal instability, clashes with the White House, and poor communication with regulated industries.

The US Food and Drug Administration launched a one-day inspections pilot in April. Under the program, the FDA will carry out one-day inspections of facilities that AI has designated as low risk. The FDA says these assessments will augment, not replace, standard inspection protocol.

A group of Democratic senators want to roll back a Medicare pilot program that uses AI to automate the approval process for several outpatient procedures. The Trump administration says the WISeR model targets fraud and waste, while opponents say it's another tool for private companies to delay care.

Several public health organizations are voicing concern over the firing of two top leaders of the US Preventive Services Task Force by HHS Secretary Robert F. Kennedy Jr. Critics say the removal of John Wong and Esa Davis erodes trust in the healthcare system and threatens public health.

Medtronic presented 24-month data from its Altaviva TITAN 2 pivotal study at the 2026 American Urological Association Annual Meeting in DC. Medtronic says Altaviva, a small device implanted just below the skin near the ankle, offers relief for millions with urge urinary incontinence.

Medline says certain Namic Manifolds used in cardiac procedures should be pulled from distribution and clinical use. The company issued the recall after identifying particulates that could enter the bloodstream, resulting in serious injury or death.

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.