Clinical Trials

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.

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

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.

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.

The US FDA continues to provide updates on the safety and efficacy of surgical mesh sling procedures, a common surgery to correct stress urinary incontinence.

The ownership of all study data would be granted to the non-commercial sponsor, says one of the many provisions proposed in the model investigator-initiated study agreement that the Health Research Authority has released for consultation.

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

The US Food and Drug Administration released seven warning letters in March 2024, of which three were related to a recent crackdown on China-made syringes. Other letters recounted troubles at Exactech, Fresenius and ReNovo, as well as clinical trial violations from Nobles Medical Technology.

This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

Yosemite, an oncology-focused VC company, founded by Reed Jobs, partnered with the American Cancer Society to launch a $13.2m grant program to fund cancer projects, including using AI for drug discovery and research in immuno-oncology and cell therapy approaches.

Women’s health leaders in the menopause space have high hopes that President Biden’s executive order will provide dollars for more research on how hormone therapy can prevent disease and draw attention to the need for provider education on menopausal symptoms.

Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment. Despite the name, the entity is also responsible for device regulation.

As a three-time cancer survivor and someone who has participated in a device trial, Alicia Staley, Medidata’s VP of patient engagement, is no stranger to innovative treatments. She spoke to Medtech Insight about how both the gender and socioeconomic diversity of trial participants could be improved.

Digital clinical trials, a trend sparked by the COVID-19 pandemic that has held the biopharma industry’s interest, are changing the way patients interact with research and improving access, says Medable’s CEO.

iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.

This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.