FDA may need to revisit its upper-end limits for ultrasound scans and a 2008 guidance
addressing use of fetal ultrasounds in light of a documented rise in the number of fetal ultrasounds expectant mothers currently...
A sharp increase in the use of fetal ultrasounds in recent years in women with healthy pregnancies from an average of 2 scans to 5 scans per pregnancy and recent warnings from medical societies could prompt FDA to look more closely at possible risks to the fetus from ultrasound.
FDA may need to revisit its upper-end limits for ultrasound scans and a 2008 guidance
addressing use of fetal ultrasounds in light of a documented rise in the number of fetal ultrasounds expectant mothers currently...
The NHS England chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.