United States

This week, the US FDA's proposed final rule on lab-developed tests cleared another hurdle on the path to release; Zimmer Biomet announced that its ROSA surgical robot had been used in shoulder replacement surgery for the first time; and a virtual menopause clinic closed out a $60M fundraising round.

The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.

The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.

People with Parkinson’s often face a “social toll” from the disease, so h2o therapeutics is focused on discreet solutions for the symptom of gait freezing that work with wearable devices.

The director of the US FDA’s device center discussed several of the center’s priorities at Medcon, such as moving beyond the pandemic, focusing on patients, and advancing health equity.

Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.

Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

Abbott initiated a recall in February of thousands of Heartmate devices due to a system obstruction that can result in serious health outcomes, including death. The FDA has now designated the recall as class I.

The rulemaking is supposed to formalize the Patent Trial and Appeal Board process, which has been in an interim status since a Supreme Court decision, giving manufacturers more ability to request oversight of the decisions. 

AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.