Digital Health

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

The DHCoE’s new page provides a one-stop-shop for frequently asked digital health policy questions.

The World Health Organization has published a report detailing the barriers to digital health’s adoption across the territories in which it operates.

The two tech companies – one software giant, the other focused on oncology – will work together on what will likely be the largest artificial intelligence model of its kind.

Click Therapeutics and Indivior will develop a digital solution for treating substance use disorders, starting with opioid use disorders. Click already signed partnership deals with Otsuka and Verily and Boehringer Mannheim to co-develop digital therapeutics for patients with schizophrenia and major depressive disorder.

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

A class-action lawsuit alleges that Medtronic shared patient data with third parties.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

After receiving US FDA clearance in May, Beta Bionics secured $100m in financing which is expected to be used to commercialize its iLet Bionic Pancreas and “further develop and test the bi-hormonal bionic pancreas.”

The American Telemedicine Association has published a new set of data principles to ensure telehealth visits meet standards for patient safety as well privacy of data and information.

The Off-the-Shelf Software Guidance updates highlight industry advancements.

Withings receives FDA clearance for first body weight scale to detect atrial fibrillation.

Technical teams have laid the cornerstone for the platform that will be developed to link up multiple public and private data sources and make it easier to access, integrate and analyze the vast and diverse range of data they contain.

This week, FDA Commissioner Robert Califf described plans for restructuring the Office of Regulatory Affairs; Studies found chatbots don’t give trustworthy advice to cancer patients; and the owner of an Atlanta genetic testing lab was sentenced to 27 years in prison over a massive Medicare fraud scheme.  

Israeli-based medtech company GaitBetter is hoping to make bigger strides in bringing its VR- and AI-based gait training and rehabilitation solution to more physical therapy clinics in the US.

The pure-play software company, which has developed a tool to record and monitor patients’ coughs, has signed a partnership to integrate its technology into a wearable.