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FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency.
In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job.
On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news
Using wearable devices in clinical trials
Brandy Chittester, chief of clinical operations, IMARC
Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns.
Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research.
How wearable devices are advancing medicine
Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description.
This in...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
10 Ways to Keep Your Heart Healthy
No one ever had fun visiting the cardiologist. Regardless of how good the doc might be, it’s always a little scary thinking about the health of something as fundamental as the heart. But there are ways to take greater control—to ensure that your own heart health is the best it can be—even if you have a family history of cardiovascular disease.
Although 50% of cardiovascular-disease risk is genetic, the other 50% can be modified by how you live your life, according to Dr. Eugenia Gianos, director of Women’s Heart Health at Lenox Hill Hospital in New York City. “This means you can greatly ...
Source: TIME: Health - October 17, 2018 Category: Consumer Health News Authors: Lisa Lombardi and Jamie Ducharme Tags: Uncategorized Baby Boomer Health heart health Source Type: news
Could 2018 Really Be the Year of AI in Medtech?
Has there really been another topic in medtech this year that has generated more attention than Artificial Intelligence? There have been numerous approvals, clearances, and even in some cases praise from regulatory bodies about AI-based medtech.
MD+DI has been on the frontlines covering the recent AI boom. That coverage spawned a webinar titled, How Artificial Intelligence Has Changed Everything for Medtech hosted by Dave Saunders CTO and Co-founder of Galen Robotics. In just a few short weeks at MD&M Minneapolis, AI will be discussed in depth at a session titled, Artificial Intelligence (AI): What You Need to Know to ...
Source: MDDI - October 9, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news
Neurologic Complications of Human Immunodeficiency Virus Infection
This article reviews the presentation, diagnosis, and management of the most common neurologic conditions associated with HIV infection and ART.
Source: CONTINUUM: Lifelong Learning in Neurology - October 1, 2018 Category: Neurology Tags: Review Articles Source Type: research
Growth Hormone Improves Cognitive Function After Experimental Stroke Basic Sciences
Conclusions—These findings provide compelling preclinical evidence for the usage of GH as a potential therapeutic tool in the recovery phase of patients after stroke.
Source: Stroke - April 23, 2018 Category: Neurology Authors: Lin Kooi Ong, Wei Zhen Chow, Clifford TeBay, Murielle Kluge, Giovanni Pietrogrande, Katarzyna Zalewska, Patricia Crock, N. David Aberg, Andrew Bivard, Sarah J. Johnson, Frederick R. Walker, Michael Nilsson, Jorgen Isgaard Tags: Angiogenesis, Basic Science Research, Growth Factors/Cytokines, Cognitive Impairment, Neurogenesis Original Contributions Source Type: research
Recurrent Hypoglycemia Exacerbates Cerebral Ischemic Damage in Diabetic Rats via Enhanced Post-Ischemic Mitochondrial Dysfunction
AbstractDiabetes significantly increases the risk of stroke and post-stroke mortality. Recurrent hypoglycemia (RH) is common among diabetes patients owing to glucose-lowering therapies. Earlier, we showed that RH in a rat model of insulin-dependent diabetes exacerbates cerebral ischemic damage. Impaired mitochondrial function has been implicated as a central player in the development of cerebral ischemic damage. Hypoglycemia is also known to affect mitochondrial functioning. The present study tested the hypothesis that prior exposure of insulin-treated diabetic (ITD) rats to RH exacerbates brain damage via enhanced post-is...
Source: Translational Stroke Research - March 22, 2018 Category: Neurology Source Type: research
The Medical Emergency Of Otto Warmbier
All that the doctors who treated Cincinnati, Ohio resident Otto Warmbier knew is what they had seen or maybe read in the news. They knew he had just been released on June 13 from imprisonment in North Korea where he had been held by for more than 17 months. He had been sentenced in March 2016 to 15 years of hard labor for allegedly removing a propaganda poster from a wall at a Pyongyang hotel where he had been staying. The University of Virginia honors student had been visiting the authoritarian state during a five-day trip with a group called Young Pioneer Tours, which is a group out of China – an important note.
Ot...
Source: Healthy Living - The Huffington Post - June 22, 2017 Category: Consumer Health News Source Type: news
7 medtech stories we missed this week: June 2, 2017
[Photo from unsplash.com]From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. Dextera seeks expanded indications for MicroCutter 5/80 stapler
Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatr...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials News Well Regulatory/Compliance Research & Development c2 Therapeutics Dextera Surgical DreaMed Diabetes EndoGastric Solutions Inc. Implandata Inolife MicroTransponder Inc. Source Type: news
September Is Childhood Obesity Month -- Get The Facts
The obesity epidemic continues to dominate headlines--and for good reason. Obesity is a leading cause of heart disease, diabetes, high blood pressure, and stroke. Many of these conditions occur in adults but often begin in childhood. This September is National Childhood Obesity Awareness Month. By knowing the facts and taking steps to help your children live a healthier lifestyle, childhood obesity and its resulting complications may be prevented.
The Facts
According to the Centers for Disease Control & Prevention (CDC), one in three children in the U.S. is overweight or obese. Childhood obesity doubled in children and ...
Source: Healthy Living - The Huffington Post - September 28, 2016 Category: Consumer Health News Source Type: news
How Your Brain Is Making You Fat (And What To Do About It)
Thousands of Americans woke up this morning and declared, "Today is the day I start my diet. Er, well, maybe tomorrow."
When you start that diet is probably irrelevant anyway. "Only 3 out of every 100 people who reach their goal manage to maintain that weight loss beyond the first year." Three! Yup, "losing weight" is no longer just an idealistic New Year's resolution; it's a daily tradition.
Why is it that human beings can shoot a rocket into space, climb Everest,
but can't refuse a piece of chocolate cake?
It's not a lack of willpower. Processed foods have changed the way our brain chemistry to a point that our bod...
Source: Healthy Living - The Huffington Post - September 22, 2016 Category: Consumer Health News Source Type: news
Linagliptin treatment improves cerebrovascular function and remodeling and restores reduced cerebral perfusion in Type 2 diabetes
In this study, we hypothesized that DPP-IV inhibition with linagliptin would improve impaired cerebral perfusion in diabetic rats, as well as improve insulin-induced cerebrovascular relaxation and reverse pathological cerebrovascular remodeling. We further postulated that these changes would lead to a subsequent improvement of cognitive function. Male Type-2 diabetic and nondiabetic Goto-Kakizaki rats were treated with linagliptin for 4 wk, and blood glucose and DPP-IV plasma levels were assessed. Cerebral perfusion was assessed after treatment using laser-Doppler imaging, and dose response to insulin (10–13 M–...
Source: AJP: Regulatory, Integrative and Comparative Physiology - August 31, 2016 Category: Physiology Authors: Hardigan, T., Yasir, A., Abdelsaid, M., Coucha, M., El-Shaffey, S., Li, W., Johnson, M. H., Ergul, A. Tags: Obesity, Diabetes and Energy Homeostasis Source Type: research
Lasting Impact of an Ephemeral Organ: The Role of the Placenta in Fetal Programming
Recent advances in molecular and imaging technologies, “omics” fields, and data sciences are offering researchers an unprecedented look at the placenta, the master regulator of the fetal environment.© EPA/National Geographic Channel/Alamy
Studies of infants conceived during the Dutch “Hunger Winter” provided some of the earliest clues that prenatal stress could affect health much later in life.© Nationaal Archief
© Evan Oto/Science Source
In one study, the placental microbiome had a similar taxonomic profile as the oral microbiome, illustrated here by...
Source: EHP Research - July 1, 2016 Category: Environmental Health Authors: Web Admin Tags: Featured Focus News July 2016 Source Type: research
Linagliptin treatment improves cerebrovascular function and remodeling and restores reduced cerebral perfusion in type 2 diabetes.
In this study, we hypothesized that DPP-IV inhibition with linagliptin would improve impaired cerebral perfusion in diabetic rats as well as improve insulin-induced cerebrovascular relaxation and reverse pathological cerebrovascular remodeling. We further postulated that these changes would lead to a subsequent improvement of cognitive function. Male type-2 diabetic and nondiabetic Goto-Kakizaki (GK) rats were treated with linagliptin for four weeks, and blood glucose and DPP-IV plasma levels were assessed. Cerebral perfusion was assessed post-treatment using laser Doppler imaging, and dose response to insulin (10(-13)- 10...
Source: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology - June 28, 2016 Category: Physiology Authors: Hardigan T, Yasir A, Abdelsaid M, Coucha M, El-Shaffey S, Li W, Johnson MH, Ergul A Tags: Am J Physiol Regul Integr Comp Physiol Source Type: research
Exercise to Extend Your Life
by Phil Hardesty
Imagine if there was a pill you could take that was free and would virtually eliminate, or at least minimize most disease processes. It would provide you with energy and strength to live your life beyond what you thought was possible. Everyone would want this pill and if it worked as well as it promised, just think of how healthy our population may be.
Of course this "pill" does exist. It's called regular physical activity and exercise.
According to the World Health Organization's Global Health Risks data physical inactivity is the fourth leading cause of death globally only behind high blood pressure, ...
Source: Healthy Living - The Huffington Post - May 9, 2016 Category: Consumer Health News Source Type: news
