Apple

FDA selects participants for new digital health software precertification pilot program

Wednesday, September 27, 2017

The FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

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Sanofi bets on virtual clinical trials

Monday, March 13, 2017

The clinical research industry is facing a crisis. Nearly 80% of trials do not meet enrollment timelines, and these delays can amount to $8 million in lost revenue per day, according to one estimate by Cutting Edge Information. But now the industry is betting on a new trend: virtual clinical research.

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Enrollment strategies in the PMI Cohort Study will bolster diversity in clinical research industry-wide

Monday, July 25, 2016

The Precision Medicine Initiative (PMI) Cohort Program is an ambitious observational study backed by the National Institutes of Health (NIH) that seeks to enroll at least one million Americans by 2020. Because of its massive scale, the Cohort Program is often compared to the 1948 Framingham Heart Study. Yet a crucial differentiator is that the Cohort Program aims to recruit participants with diverse backgrounds and ethnicities to better understand the root cause of disease for all Americans.

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Apple to launch new software framework CareKit

Thursday, March 24, 2016

Apple is launching CareKit, a new software framework designed to help developers enable people to actively manage their own medical conditions. iPhone apps using CareKit make it easier for individuals to keep track of care plans and monitor symptoms and medication; providing insights that help people better understand their own health. With the ability to share information with doctors, nurses or family members, CareKit apps help people take a more active role in their health.

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Smartphone app revolutionizes clinical trial consent and data sharing

Monday, March 14, 2016

Sage Bionetworks, a Seattle-based nonprofit, has released the first six months of data from a new iPhone app that captures the everyday experiences of more than 9,500 study participants. The app, called mPower (Mobile Parkinson’s Observatory for Worldwide, Evidence-based Research), manages and simplifies the research study, from patient recruitment through the enrollment and consent process. It also enables researchers to collect extensive data from patients with and without Parkinson’s disease. Data from the study can be used to assess the ability of mobile apps to improve the paradigm for clinical studies.

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Digital clinical research is nearing a tipping point

Monday, January 18, 2016

The Pulse on Global Trials by Matthew Howes

Since I started writing this column two years ago, clinical research has seen modest improvements in failure rates of late stage trials, but for the most part drug development remains unnecessarily expensive and inefficient. 

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Propeller deal echoes trend in wearable devices

Monday, December 7, 2015

The number of small, pilot clinical trials to evaluate new wearable devices continues to grow, as the once-untested technology is becoming another research tool for companies focused on developing new sensors for both handheld and wearable products.

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