Food and Drug Administration (FDA) Blogs This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Dipstick Technology Approved by FDA for Urinalysis at Home
I seem to have lost track of advancements in dipstick technology understanding that it is well established in such areas as pregnancy testing. Home glucose testing for diabetics, of course, is growing increasingly sophisticated with the test strips beingread by a meter. A recent article indicated that this meter technology can be replaced by the camera in a smartphone for recording and analyzing dipstick color changes when screening for kidney disease (see:FDA approves smartphone camera –based dipstick product). Below is an excerpt from the article: Healthy.io, based in Tel Aviv, Israel, has obtained U....
Source: Lab Soft News - May 6, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Clinical Lab Industry News Clinical Lab Testing Diagnostics Food and Drug Administration Healthcare Information Technology Healthcare Innovations Lab Industry Trends Lab Processes and Procedures Medical Consumerism Medical Research Poi Source Type: blogs

Sophisticated Monitors Move into Homes; Inpatient and Home Care Merge
I have posted a number of notes abouthealth wearables and monitors (see, for example:Is Healthcare Ready to Embrace the Consumer"Wearable" Revolution?;AT&T Offers the LTE-M, Low-Powered Network for Uploading Wearable Health Data). These devices will have a major effect on both healthy consumers as well as the chronically ill. In the former case, wearables can be used to monitor daily activities and, using various types of descriptive, diagnostic, and predictive analytics, will guide consumers in their pursuit of wellness (see:Healthcare Will Contribute a Sizable Portion of Future Earnings for Apple).�...
Source: Lab Soft News - April 29, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Cost of Healthcare Diagnostics Electronic Health Record (EHR) Food and Drug Administration Healthcare Information Technology Healthcare Innovations Point-of-Care Testing Predictive Analytics Preventive Medicine Source Type: blogs

How one woman prevented a pharmaceutical disaster
An excerpt from Frankie: How One Woman Prevented a Pharmaceutical Disaster. Between September 1960 and November 1961, when the news broke around the world about thalidomide’s responsibility for the birth of deformed babies, Dr. Frances Kelsey— Frankie— of the Food and Drug Administration (FDA) and the Cincinnati drug company Merrell, that was desperate to […]Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - April 28, 2019 Category: General Medicine Authors: < span itemprop="author" > < a href="https://www.kevinmd.com/blog/post-author/james-essinger-and-sandra-koutzenko" rel="tag" > James Essinger and Sandra Koutzenko < /a > < /span > Tags: Meds OB/GYN Source Type: blogs

Questions about the Interpretation of BRCA Testing by 23andMe
Lab testing for the genes that predispose a person to develop cancer is highly complex, both to preform and interpret. For example and relating to BRCA, I have blogged about some of the pitfalls of such testing (see:BRCA Exchange Available on the Web; Understanding BRCA Variants). Here's a quote from this note discussing some of the complexities that are encountered:It's not known among some healthcare consumers that there are a host of BRCA variants other than the standard ones. Normal BRCA testing looks forthree specific genetic variants that are linked to hereditary cancers. Two of these variants —...
Source: Lab Soft News - April 19, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Clinical Lab Industry News Clinical Lab Testing Diagnostics Direct Access Testing (DAT) Food and Drug Administration Genomic Testing Healthcare Innovations Lab Industry Trends Lab Regulation Medical Consumerism Medical Education Medi Source Type: blogs

CMS Offers $1M Reward for AI to Predict Unplanned Hospitalizations
Regarding the use of artificial intelligence (AI) to provide efficiency gains in various healthcare processes, there have been a number of articles suggesting how to launch this new technology. I have discussed AI analytics in multiple blog notes (see, for example:Healthcare AI Market to Surge; Already Commonplace in Radiology;Cerner Offers AI Tool to Combat Physician EHR Burnout;Which Healthcare Jobs Are Safe from Replacement by Automation or Robots?). Hospitals will certainly be pursuing this goal on their own in order to reduce risk and costs. A recent article indicated that CMS was accelerating this process by launchin...
Source: Lab Soft News - April 16, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Cost of Healthcare Electronic Health Record (EHR) Healthcare Information Technology Healthcare Innovations Hospital Financial Predictive Analytics Preventive Medicine Source Type: blogs

The FDA warns consumers not to use unapproved apps and devices to diagnose concussion
_______ FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion (news release): Today, the U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. In a new safety communication, the FDA warned that such tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnos...
Source: SharpBrains - April 12, 2019 Category: Neuroscience Authors: SharpBrains Tags: Cognitive Neuroscience Health & Wellness Technology concussion FDA head-injury medical devices TBI Traumatic-Brain-Injury Source Type: blogs

Smartphone Camera Utilized to Analyze Urine Dipstick Color Changes
When I look to the future of home-based, consumer-oriented lab testing, I tend to think mostly about lab-on-a-chip using mocrofluidics (see:INTRODUCTION TO LAB-ON-A-CHIP 2015 : REVIEW, HISTORY AND FUTURE). Often forgotten has been dipstick technology that has been used for many decades for urinalysis and pregnancy testing. Now comes news that an Israel-based company is using smartphone cameras to more precisely interpret the color changes in dipsticks (See:Healthy.io uses your smartphone's camera for medical lab testing at home). Below is an excerpt from the article:Dip.io uses a smartphone and a dipstick to perf...
Source: Lab Soft News - April 6, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Clinical Lab Industry News Clinical Lab Testing Diagnostics Food and Drug Administration Healthcare Innovations Lab Industry Trends Lab Processes and Procedures Medical Consumerism Medical Research Point-of-Care Testing Test Kits and H Source Type: blogs

Supersaturated oxygen reduces infarct size in anterior wall infarction
United States Food and Drug Administration (US FDA) has approved SuperSaturated Oxygen (SSO2) Therapy for reducing infarct size in left anterior descending coronary artery territory ST elevation myocardial infarction (STEMI) within 6 hours of onset, after percutaneous coronary intervention. How is supersaturated oxygen delivered? Supersaturated oxygen is delivered using an extracorporeal circuit (TherOx, Inc, Irvine, Calif). Blood is withdrawn from the sidearm of the femoral sheath which is chosen to be 2F larger than the PCI guide or from a 5F sheath in the opposite femoral artery. The blood is oxygenated in a polycar...
Source: Cardiophile MD - April 6, 2019 Category: Cardiology Authors: Prof. Dr. Johnson Francis Tags: Coronary Interventions Source Type: blogs

Need for Immediate Action to Eliminate Gag Clauses in EHR Contracts
I have blogged frequently about the gag clauses that have been a standard part of EHR contracts for decades (see, for example:Physician& Nurse Involvement in EHR Design; Patient Safety and EHR Gag Clauses;Gag Clauses in EHR Contracts Documented; Concerns Raised about Patient Safety;Legislation Introduced in Senate to Address Gag Orders in EHR Contracts). Hospital personnel encountering EHR issues that can compromise patient safety are restricted by such clauses from discussing them with anyone other than their EHR vendor. Compare this with drug adverse effects which by law must be reported to the FDA as well as t...
Source: Lab Soft News - April 3, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Tags: Blood banking Electronic Health Record (EHR) Food and Drug Administration Healthcare Information Technology Medicolegal Issues Pathology Informatics Public Health Quality of Care Source Type: blogs

The Most Pressing Issues In Bioethics
Who owns medical and genetic data? How to regulate gene editing? Where is the boundary of enhancing physical or cognitive human capabilities? What to do with biological differences widening the gap of the haves and have-nots? Could we define where is the boundary to augment life? Will we sue robots or algorithms for medical malpractice? With the constant advancement of technology, unprecedented moral, ethical and legal concerns are surfacing. Channeling them into substantial debates will get us closer to their fair solution step by step. Here, we collected the most pressing issues in bioethics. Bioethicists of the world...
Source: The Medical Futurist - March 26, 2019 Category: Information Technology Authors: nora Tags: Bioethics Cyborgization Genomics bioethical data debate DNA future gene editing genetic genetics Innovation legal longevity medical medical data moral sex sexuality technology Source Type: blogs

Treating depression with ketamine: We need incremental treatment for depression
Recently, the Food and Drug Administration approved a nasal spray version of the drug Ketamine, named Spravato (esketamine), for use as a supplement to oral antidepressants taken by adults living with treatment-resistant depression. The announcement was accompanied by a flurry of media excitement as Spravato is the first medication for depression with a new mechanism […]Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - March 25, 2019 Category: General Medicine Authors: < span itemprop="author" > < a href="https://www.kevinmd.com/blog/post-author/shaili-jain" rel="tag" > Shaili Jain, MD < /a > < /span > Tags: Meds Psychiatry Source Type: blogs

San Francisco Considering Banning Electronic Cigarettes, But Letting Deadly Real Cigarettes Stay on the Shelves
Yesterday, San Francisco City Attorney Dennis Herrera and Supervisor Shamann Walton announced that they are introducing an ordinance to the Board of Supervisors that would ban all electronic cigarettes until they are officially reviewed and approved by the Food and Drug Administration (FDA). Since there is not a single e-cigarette on the market that has undergone such an approval process, the ordinance does indeed ban the sale of all electronic cigarettes in the city of San Francisco.The reasoning behind the proposal is as follows: " Today we are taking action to protect our kids. By law, before a new tobacco product goes ...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - March 20, 2019 Category: Addiction Source Type: blogs

New ACR Document Questions the Ethical Use of AI in Radiology
The American College of Radiology and several other radiology organizations have released a consensus documentanalyzing the ethical implications of artificial intelligence (AI) in medical imaging. The 38-page report examines the practice of AI in radiology, and how the technology could possibly influence and change the specialty. “Most changes will be positive,” the authors write, “but some may be for the worst.”The document promotes a discussion on how to effectively use AI while implementing standards, policies, and rules of conduct for ensuring that the technology is administered ethically and transparently. T...
Source: radRounds - March 16, 2019 Category: Radiology Authors: Julie Morse Source Type: blogs

Just do it … yourself: At-home colorectal cancer screening
Colorectal cancer (CRC) is the fourth leading cause of death worldwide. Yet despite the ability of CRC screening to detect colon cancer early, and to find and remove potentially precancerous growths called polyps, screening rates remain low, below 60%. Experts generally agree that people should be screened for CRC at regular intervals beginning by age 50. Colonoscopy is considered the gold standard for CRC screening. In this procedure, a doctor examines your entire colon through a colonoscope, a flexible tube outfitted with a small video camera and a light. But concern around pre-colonoscopy bowel cleaning, which can be un...
Source: Harvard Health Blog - March 12, 2019 Category: Consumer Health News Authors: James Richter, MD Tags: Cancer Screening Tests and procedures Source Type: blogs

FDA Authorizes 23andMe to Offer Pharmacogenetic Testing on Consumers
Direct access testing (DAT), also called direct to consumer (DTC) testing, is consumer-initiated testing via the web with consumer payment. Such testing has been available for many years. Here's my note about the topic from 2006:Four Categories of Direct Access Testing. The early DAT test menu covered mainly routine tests with the addition of more esoteric ones over time. Now comes news that the FDA is authorizing direct-to-consumer (DTC) pharmacogenetics tests (PGx) without a physician order by 23andMe (see:FDA Authorizes 23andMe to Report Results of Direct-to-Consumer Pharmacogenetics Test to Customers without a Pres...
Source: Lab Soft News - March 6, 2019 Category: Laboratory Medicine Authors: Bruce Friedman Source Type: blogs