Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx, Freespira, GE Healthcare, Know Bio, Prevencio, Rebrain.
As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations.
The long-term status of the trade dispute with China remains unclear, but a 90-day reduction in stratospheric tariffs imposed by the U.S. and China on their respective products provides breathing room for the med-tech companies predicting the hardest hit from the original levels.
Chipiron SA will produce a prototype of its ultra-low portable magnetic resonance imaging (MRI) scanner, after raising $17 million in series A financing, as it looks to make MRI more accessible.
Med-tech M&A activity rebounded in April, reaching $1.4 billion, a sharp increase from March’s $22.63 million, though still down from nearly $5 billion in January and $6 billion in February.
Device makers may find it difficult to avoid running afoul of the Anti-Kickback Statute, but a recent case in the U.S. Court of Appeals for the Seventh Circuit suggests that the statutory definition of a referral is not set in stone.
The U.K. National Institute for Health and Care Excellence (NICE) endorsed the use of the Orbit system by Mindtech Ltd. as a treatment for tics and Tourette syndrome.
RSS
