The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
As Medicare physician reimbursement continues in 2025 to suffer from damaging shortfalls due to budget neutrality and lack of an inflation adjuster, steps are being taken in Congress to address the issue. On January 31, the...more
Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more
The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more
In Zean v. Fairview Health Services, the U.S. Court of Appeals for the Eighth Circuit recently affirmed the district court's dismissal of a putative class action complaint under the Telephone Consumer Protection Act (TCPA)....more