August 16, 2018 NASH (*) has emerged as a concern for healthcare systems and a major opportunity for drug developers in recent years. The condition, a severe form of fatty liver disease, can arise as a comorbidity in people suffering from obesity and type 2 diabetes and can lead to cirrhosis. Drug developers including Intercept and … Read more
August 14, 2018 Officials at the FDA asked for insights into how the Agency can streamline its regulations late last year. Now, with the comment period closed, the FDA has published details of how companies and trade groups want it to repeal, replace and modify its regulations. The feedback spans multiple areas of device regulation … Read more
August 09, 2018 Cardiogram, an Apple Watch app developer, ran a study on 14,011 of its users in conjunction with researchers at UCSF (University of California/San Francisco). After using data on some of the participants to train a deep neural network, called DeepHeart, the team tested the algorithm on results from the remaining cohort of … Read more
August 07, 2018 Embrace looks like other smart-watches and activity trackers and shares some of their features. The key difference is Embrace pairs its gyroscope, accelerometer and thermometer with an electrodermal activity (EDA) sensor and an algorithm that analyzes the data stream for signs the wearer is suffering a seizure. EDA indicates whether a person is … Read more
August 03, 2018 Full details of what Apple is planning have yet to emerge but its disclosures to participants in the study have sketched an outline of its intentions. The latest communication from Apple gave participants in the ResearchKit study informed consent documents to sign ahead of the initiation of data collection. A section of … Read more
August 01, 2018 In a study published in the Journal of Alzheimer’s Disease, the researchers said they implanted thin electrical wires into the frontal lobes of patients with Alzheimer’s disease to see if using a brain pacemaker could improve cognitive, behavioral and functional abilities in patients with this form of dementia. They found that using DBS … Read more
July 28, 2018 Apparently not. In January 2018, at the swearing-in ceremony for new HHS Secretary Alex Azar, Trump said Azar would bring drug prices “way down.” However, this time, despite the familiar words, the President’s comments did not touch off nearly the same reaction on Wall Street, signaling that industry and investors may be … Read more
July 24, 2018 Health systems like Boston Children’s Hospital and Cedars-Sinai Medical Center in Los Angeles have been exploring ways to integrate Amazon’s Alexa into the clinical environment, according to CNBC, in some cases using it to improve compliance with surgical safety checklists. Silicon Valley venture capitalists are also keen on health apps that could … Read more
July 19, 2018 The technology giant is partnering with JPMorgan Chase & Co. and Berkshire Hathaway to launch an independent healthcare company “that is free from profit-making incentives and constraints,” according to a January 2018 announcement. While the specifics of the new company are still in the planning stages, the initial focus will be on … Read more
July 17, 2018 Talking at a precision medicine panel at the World Economic Forum in Davos, Switzerland in January, details of which were first reported by Regulatory Focus, Gottlieb sketched out how he wants to change the regulation of diagnostics during his tenure as head of the FDA. “I think it’s incumbent upon us to … Read more