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...
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.
This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.
The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.
The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.
Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
