Bezos joins Gates-backed Alzheimer’s diagnostics accelerator with new focus on digital biomarkers

July 30, 2019 With new support from Amazon founder Jeff Bezos and other donors, the Diagnostic Accelerator “venture philanthropy” project at the Alzheimer’s Drug Discovery Foundation (ADDF) is poised to name its first grantees in the near future and has begun taking applications for a second round of grants focused on fast-tracking digital tools for … Read more

FDA lays out plans for a new review framework for Artificial Intelligence (AI) and machine learning- based devices

July 25, 2019 The Agency hopes a tailored regulatory framework will help promote the development of machine-learning devices and programs, which FDA Commissioner Scott Gottlieb says “have the potential to fundamentally transform the delivery of healthcare.”  “As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies … Read more

As Brexit delayed, wannabe next Prime Minister wants to slash trial regulations

July 23, 2019 Seems a rather odd choice for Michael Gove, a British conservative member of Parliament and former cabinet minister, given the ongoing deadlock at Parliament.  However, Gove, who alongside former London Mayor Boris Johnson is a leading favorite to be the next leader of Britain (as current PM Theresa May appears to be … Read more

Device-safety experts to FDA: Make data public

July 18, 2019 A recent Kaiser Health News (KHN) investigation revealed that the FDA granted device makers numerous “exemptions” from the standard rules of publicly reporting harm related to devices.  One such program began about 19 years ago and allowed companies to file alternative summary reports about injuries or malfunctions into a database not visible … Read more

Treating heart failure by targeting fat metabolism

July 16, 2019 Before any physical signs or symptoms of heart failure emerge, chronically stressed cardiac cells undergo changes to adapt; however, the adjustments do not necessarily make things better, said Doug Lewandowski, Ph.D., an Ohio State researcher who focuses on cardiac metabolism, in a statement.  Lewandowski’s team discovered that deficiencies of a reactive fat … Read more

Bayer taps Swedish smart pillbox developer to encourage drug adherence

July 09, 2019 The company, Pilloxa — born out of the Karolinska Institute, the Royal Institute of Technology and the Stockholm local government — says that patient noncompliance can dramatically increase strains on the healthcare system in terms of lives, time and costs. The app also contains an up-to-date medicines list, a dashboard for the patient’s … Read more

A smart toilet seat to detect heart failure?

July 04, 2019 Developed by researchers at the Rochester Institute of Technology, the sensors embedded in the high-tech seats will be privy to a person’s heart rate, blood pressure and oxygenation levels, as well as the amount of blood pumped out of the heart with every beat.  The intent of the university’s spinout, christened Heart … Read more

FDA to launch scientific review of implant biocompatibility, following patient reactions to certain materials

July 02, 2019 While the vast majority of patients have no adverse reactions to implants constructed of metal, plastic or silicone, the Agency said some may still develop inflammatory responses and tissue changes several years following the initial procedure, with symptoms that might not occur until long after a clinical study.  Those symptoms, both local … Read more