Rep. Mike Fitzpatrick, R-Pa., is asking FDA's criminal office to investigate whether Ethicon and several East Coast hospitals fulfilled safety reporting requirements for power morcellators, which have been linked to a risk of spreading cancer in women undergoing treatment for uterine fibroids.
Rep. Mike Fitzpatrick, R-Pa., has asked FDA's criminal division to investigate Ethicon Inc.'s conduct in marketing power morcellators that have been linked to the spread of undiagnosed cancers in women undergoing treatment for uterine fibroids.
In a Dec. 18 letter
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved transparency, streamlined reviews, enhanced safety measures, and greater patient involvement.
Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.
NHS England's national 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.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
