The convergence of US and European regulations is set to transform quality management systems for AI-enabled medical devices. The FDA's adoption of ISO 13485:2016 in February 2026, alongside efforts by the CEN/CENELEC Joint Technical Committee to harmonize standards under the AI Act, will streamline regulatory compliance. Manufacturers investing in integrated QMS frameworks can expedite algorithm development, reduce liability risks, and enhance interactions with regulators, gaining a competitive edge in innovation, quality and patient safety.

Siemens Healthineers reported mixed results for the first quarter of 2026, with adjusted earnings before interest and taxes falling 1.5% to $953 million, surpassing profit expectations, and revenue falling 1.5% to $6.376 billion, missing estimates. The company faces challenges such as currency headwinds and a structural price reset in China's diagnostics market, which led to a 4.8% decrease in revenue in China.

Jake Leach, CEO of DexCom, said he believes continuous glucose monitoring can enhance outcomes for people with type 2 diabetes who are using GLP-1 medications. Leach said CGMs offer real-time glucose data, helping patients and physicians optimize therapy, and added that CGMs are cost-effective, with a year of use costing about $1,000.

A jury has ordered Medtronic to pay $382 million to Applied Medical Resources after finding sales practices for its LigaSure device violated antitrust laws. Medtronic says that surgeons "choose Medtronic's LigaSure device time and again because it outperforms Applied's Voyant" and that it plans to appeal.

GE HealthCare is collaborating with Diagnoly to integrate the Fetoly artificial intelligence platform with the Voluson ultrasound system to improve fetal ultrasound examinations. Fetoly provides real-time, standardized assessments that align with International Society of Ultrasound in Obstetrics and Gynecology guidelines and has 510(k) clearance and a CE mark.

Zimmer Biomet has received 510(k) clearance from the FDA for its G7 TM Acetabular System, designed for primary and revision hip replacement surgeries. The device offers trabecular metal technology, an anatomically derived screw hole pattern and rim fix screws.

MedCognetics has received 510(k) clearance from the FDA for its CogNet AI-MT+ software platform, which integrates into imaging and IT systems to prioritize digital breast tomosynthesis exams for review. The platform uses artificial intelligence and machine learning to detect early signs of cancer across diverse populations.

Eyas Medical Imaging has received 510(k) clearance from the FDA for its Ascent3T neonatal MRI system, which is designed specifically for neonatal and infant anatomy. The system addresses the limitations of using adult-sized MRI systems for infants.

Insightec has received a medical device license from Health Canada for its Exablate Prime MR-guided focused ultrasound system. The system, already approved by the FDA, is designed to treat essential tremor and features an intuitive user interface, automated planning steps and advanced visualization options.