510(k) for Inlet Medical's surgical kit for pelvic pain:
This article was originally published in Clinica
Inlet Medical has received clearance from the US FDA to market its Metra PS disposable surgical kit. The product provides the complete set of instruments required to carry out laparoscopic uterine suspension, a procedure designed to treat chronic pelvic pain in women caused by a retroverted or tipped uterus. The operation takes approximately 12 minutes to perform.
You may also be interested in...
Aker BioMarine seeks supplement firms to use its EPA/DHA innovation bound by lysophosphatidylcholine to enable the fatty acids to pass through the blood-brain and blood-retinal barriers and boost of eye and brain health benefits. It will submit an NDI notificaion in the US during 2022.
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.