The new guidance from the US FDA urges physicians to discuss with patients the benefits and risks of using a laparoscopic power morcellator to remove uterine fibroids, and adds some language around LPM containment systems that wasn’t included in the draft of the document.
The US Food and Drug Administration stresses in a new final guidance document that physicians discuss with patients the benefits and risks of using a laparoscopic power morcellator (LPM) to remove uterine fibroids.
“As part of shared decision-making, physicians should discuss the risks and benefits of all relevant treatment options with their patients...
Remepy is exploring two potential regulatory pathways to support this strategy. The first is a combination product pathway that would formally integrate software and drug into a single therapeutic entity. The second is the FDA’s Prescription Drug Use-Related Software (PDURS) pathway.
Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics
GE HealthCare launches bkActiv S series – part of the bkPortfolio family of Active Imaging systems.
