Medtronic StratMR Device Gets Class I Recall
Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.
You may also be interested in...
On this week’s podcast, executive editor Shawn M. Schmitt chats with senior reporters Danny Al-Faruque and Sue Darcey about specific pieces of legislation that are expected to pass through the US Congress in the new year and how they’ll impact the medical device sector.
Though it didn’t even get to committee, a bill to make it easier for tech companies to patent software – including medical software – has a good chance of getting passed in Congress this year, bill proponents and legal experts say.
The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.