FDA clears seizure-detecting wearable for epilepsy patients

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

Apple eyes FDA approval filing for investigational heart device

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

Ohio State researchers find pacemaker-like device reduces Alzheimer’s effects

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

Trump pledges new HHS Secretary Azar will get drug prices ‘way down.’ Why aren’t pharma investors scared?

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

Hospitals want to use Amazon’s voice recognition software, but real-world hurdles remain

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

Big Pharma greets hundreds of ex-federal workers at the ‘revolving door’

July 13, 2018 A Kaiser Health News (KHN) analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services.  Azar was confirmed in January as HHS Secretary, joining other former drug industry alumni in top positions. Nearly … Read more

FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims

July 10, 2018 The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) in January posted joint Warning Letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.  “The FDA is … Read more

Stopgap funding bill delays enforcement of medical device tax

July 06, 2018 Republicans’ failure to overturn Obamacare or include measures to repeal the 2.3% medical device levy in broader tax legislation meant the previously delayed charge came into force at the start of the year, despite intense industry lobbying and opposition to the tariff among both political parties. Now, with the day on which … Read more