By Inga Rose & and Aaron Schlum – On May 6, FDA published a final rule that will change the way laboratory-developed tests are regulated. The rule phases out the agency’s general policy of “enforcement discretion” and mandates that, across five stages within the next four years, LDTs will be beholden to the same regulatory requirements as in vitro diagnostics.
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By Patrizia Cavazzoni MD & Peter Marks MD PhD – An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare conditions are life threatening, and most do not have approved treatments.
By Hilary Marston MD MPH & Kevin Bugin PhD – Breakthroughs in science and technology are advancing innovation in more areas of medicine, providing novel treatment options for patients. The scientific community has a deepening understanding of disease and human biology, and of the enormous potential afforded through new technologies.
This month’s AI report includes news and updates from eClinicalWorks, Viz.ai, NICO Corp, ModMed, Medtronic, Greenway Health, Nabla, Innovaccer, Accolade, Inc., GE Healthcare, HubStar, Wolters Kluwer, Eko Health, DrFirst, Nextech, & more!
By Robert Califf – What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.
We are seeking out the latest developments around virtual healthcare. News from Iris Telehealth, Caregility, Amazon Clinic, GNC, American Hospital Association, TytoCare, Amwell, 19Labs, Teladoc Health, Evernorth, MDLIIVE, DocVilla, FDA, InfoBionic, and more.
By Meredith Calloway – Take a scroll through your smartphone’s app store, and you’ll find a wide array of applications on everything from fitness and nutrition tracking to fitness coaching and physiological monitoring available for download.
Health IT product news from Rhinogram, Teladoc, HealthPoint Plus, Pearl, Twist Bioscience Corporation, DeliverHealth, Snowflake, Turquoise Health, Sphere, 4medica, DrFirst, HHS Technology Group, Inovalon, and more.
The health IT industry is driven by growing demand for improved patient safety and patient care as well as increase in government initiatives to promote and adopt health IT. It is estimated to reach $149,178 million by 2025. Here is product news that is making these number real.