Durable Medical Equipment

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.

During an online seminar hosted by the Alliance for a Stronger FDA, Commissioner Robert Califf discussed key issues facing the agency, including supply chains, device shortages, and the risk of another pandemic.

Smiths Medical has recalled scores of Bivona tracheostomy tubes due to a manufacturing defect that can result in disastrous consequences. The company reports multiple injuries, and one death, linked to the devices.

Sonio says its acquisition by global medical equipment company Samsung Medison is a wrap. Plans for the deal were announced earlier this year.

California’s Toxic-Free Medical Devices Act to prohibit use of di-2-ethylhexyl phthalate in IV bags and tubing, now headed to Gov. Gavin Newsom’s desk, has broad support from lawmakers and a lack of opposition from industry at this stage. Pennsylvania is considering a similar bill, but with differences that could portend a patchwork legislation problem ahead in the US.

Inari Medical is updating use instructions for a clot-removing catheter due to the potential for serious adverse effects, including death.

The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.