The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

This week, Change Healthcare admittedi ts February breach revealed sensitive information like medical diagnoses and Social Security Numbers; the Coalition for Health Artificial Intelligence released its Assurance Standards Guide and Reporting Checklist for developers; and the FDA announced public meetings in July on IVD classification, the Home as a Health Care Hub initiative, and device sterilization.

A Friday Supreme Court ruling could create uncertainty for the medtech industry by giving judges more latitude to overrule executive-branch decisions. While some pro-business groups applauded the decision, others saw risks as well as benefits.

A new FDA lab-developed test compliance guide for small enterprises summarizes agency policy but fails to address clinical lab industry concerns about the LDT final rule.

A recent review of orthopedic device approvals between 2018 and 2022 found that less than 10% of 510(k) devices – and less than 5% of PMA and de novo products – have been authorized for use in children, highlighting the ongoing lack of pediatric devices. 

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.