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News We're Watching: LDT Final Rule Near Publication, Zimmer ROSA Used In Shoulder Surgery, $60M For Menopause Clinic
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.
Epitel Gets 510(k) Clearance On Remote EEG Technology
The REMI Remote EEG monitoring system and REMI Vigilenz AI could help patients with infrequent seizures get a quicker diagnosis.
Rise In Class I Device Recalls A ‘Grave Concern,’ Says FDA’s Anne Reid
The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.
Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch
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.
Shuren Says CDRH Is ‘Turning The Ship Around’ As Operations Return To Normal
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 Sterilization Companies Poised To Meet EtO Emissions Goals On Time
Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.
CDS Final Guidance Draws More Criticism, This Time From Congress
Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.
Alarming Rise Of Diabetes in Several US States, Study Shows
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.
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
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.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
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.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
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.
Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application
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.
Interview: Theradaptive To Enter Clinical Trial For Spinal Fusion Implant
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.
More Heartmate Troubles For Abbott. Latest Recall Includes 14 Deaths
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.
Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests
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.
It’s Been Over 1100 Days Since MCIT, Still No TCET In Sight
AdvaMed’s new online clock documents the time since CMS promised to replace MCIT, a program guaranteeing coverage for FDA-cleared breakthrough devices.
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