Digital Health
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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.

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.

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.

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.

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.

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.

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.

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.

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.”

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.

OTS Software Guidance Update Underscores Industry Advancements
The Off-the-Shelf Software Guidance updates highlight industry advancements.

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.

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.

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.

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.

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.
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