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Clinical / R & D

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Clinical Trials

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Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease

Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.

Patient Monitoring Commercial

Lilly Can Rest Easy As Tirzepatide Scores Phase III Sleep Apnea Win

Topline results from two studies in obstructive sleep apnea among obese adults showed efficacy crossing the 50% threshold that physicians have called clinically meaningful.

Clinical Trials Metabolic Disorders

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.

Clinical Trials Diversity & Inclusion

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.

Regulation Commercial
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New Technology

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Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease

Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.

Patient Monitoring Commercial

At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use

At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.

Innovation In Vitro Diagnostics

MAISI: Navigating The 'Valley Of Death' In Medtech Research Translation

Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.

Europe United Kingdom

Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities

Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.

Artificial Intelligence Commercial
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Approvals

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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.

Approvals FDA

Cochlear’s Osia System Receives Expanded FDA Clearance For Use In Younger Children

Kids ages 5 and up now can benefit from Cochlear’s Osia implant and sound processor, indicated for hearing loss, mixed hearing loss and single-sided sensorineural deafness.

Approvals FDA

News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR

This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

News We're Watching Approvals

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.

FDA Diagnostics
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