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Digital Health

Set Alert for Digital Health

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

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.

Diversity & Inclusion Business Strategies

Digital Health Center Of Excellence Publishes Policy FAQs

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

Digital Health FDA

As Digital Health Races Forward, Governments’ Understanding Of It May Be Stalling

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

Digital Health Legislation

Minute Insight: Paige Strikes It Big With Microsoft Partnership

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.

Minute Insights Artificial Intelligence

Click Therapeutics And Indivior Collaborate On Prescription Digital Therapeutics In Substance Use Disorder

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.

Artificial Intelligence Behavioral Health

Medtech Connect Episode 9: The Intersection Of IVDs And Digital Health

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.

Digital Health Diagnostics

Medtronic Faces Class-Action Lawsuit Over Alleged Patient Data Sharing From MiniMed, InPen Diabetes Devices

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

Legal Issues Diabetic Care

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

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.

Digital Health Artificial Intelligence

Beta Bionics Secures $100M In Series D Funding To Expand Artificial Pancreas Tech

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.”

Financing Diabetic Care

ATA Publishes Data Principles Aimed At Telehealth Privacy

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.

Policy Telehealth

OTS Software Guidance Update Underscores Industry Advancements

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

Regulation FDA

Withings' Smart Scale Passes US FDA Test; Clearance For Detecting Atrial Fibrillation

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

Approvals FDA

Pan-EU Health Data Sharing Platform Takes Shape

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.

Europe Digital Health

News We’re Watching: Califf Talks ORA Reorg, Contaminants Bring Ventilator Recall, 27-Year Sentence On Medicare Fraud

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.  

Regulation Approvals

GaitBetter On Mission To Bring VR, AI-Based Solution To Gait Training; Will Physical Therapists Pay For It?

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.

Neurology Innovation

Minute Insight: Hyfe Goes Physical With Wearable Partnership

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.

Minute Insights Strategy
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