Murj wants to give data collection from implantable medical devices an upgrade

Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.

The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd Butka began thinking about ways to make the data collected by cardiac technologies more easily available to physicians and diagnosticians.

Now the company is coming to market with backing from True Ventures and Social Capital.

Unlike existing technologies that deliver data in static .pdf documents, Murj collects the data and stores it in its own off-premise data warehouses. Using dashboards and other visualization tools doctors can get a better read on what’s going on with their patients’ heart health, Butka claims.

“The information comes from the devices to the implantable devices’ servers… We ping the servers,” Butka explained.

The Murj launch wraps up three years of work developing the technology, which was founded in 2014 and raised its first money in 2015.

The company, based in Santa Cruz, brought on Chris Irving as its lead designer and Patrick Beaulieu, an 18 year veteran of the medical device business, as its chief technical officer.

I think of the company as sort of an Apple Healthkit for implantable devices. If it can expand its scope beyond pacemakers and heart monitors to a broader range of implantables, it could be a pretty big business.

As the population ages, and technologies improve, demand for more persistent diagnostic tools will grow.

In a sense this is part of a number of companies that are trying to provide better tools to manage the data coming off of the sensors that we’ve got all around us.

 

Read More: http://snip.ly/kvqol#https://techcrunch.com/2017/04/18/murj-wants-to-give-data-collection-from-wearable-devices-an-upgrade/

Study finds link between increased brain glucose levels and Alzheimer’s

A new study published yesterday in Alzheimer’s & Dementia: the Journal of the Alzheimer’s Association, found a link for the first time between abnormalities in the mechanism of glucose breakdown in the brain and the severity of tangles and amyloid plaques in the brain, as well as the commencement of visible symptoms of Alzheimer’s disease.

Credit: Juan Gaertner / Shutterstock.com

This National Institute on Aging-supported study analyzed the brain tissue samples at autopsy from participants involved in the Baltimore Longitudinal Study of Aging (BLSA). BLSA, which is one of the world’s longest-running scientific studies on human aging, records neurological, psychological as well as physical data of participants over many decades.

In the study, glucose levels in various areas of the brain, such as the temporal and frontal cortex that are prone to Alzheimer’s disease pathology as well as some resistant areas like the cerebellum, were evaluated.

The researchers investigated three different categories of BLSA participants during the study — (a) participants with Alzheimer’s symptoms throughout life and with confirmed pathology of Alzheimer’s disease, including neurofibrillary tangles and beta-amyloid protein plaques in the brain at the time of death; (b) those who lacked symptoms throughout life, yet had notable levels of Alzheimer’s pathology identified during the brain post-mortem; and (c) healthy controls.

The findings indicated discrete abnormalities in glycolysis, which is the major process involved in the breaking down of glucose in the brain, and provided evidence associating the severity of the abnormalities with the severity of the disease pathology.

Poorer glycolysis rates and increased levels of brain glucose were linked with more severe tangles and plaques in the brains of people affected with Alzheimer’s. Also, the more serious declines in brain glycolysis were associated with the manifestation of disease symptoms like memory issues during life.

Richard J. Hodes, M.D, the NIA Director, commented that this kind of research initiates novel ideas on how to investigate the connections between glycolysis, symptoms, and the disease pathology in escalating the search for better and more effective treatment and prevention methods for Alzheimer’s disease.

Even though the likenesses between Alzheimer’s and diabetes had been suspected for a long time, an evaluation of the link has remained difficult, as insulin is not required for the entry of glucose to the brain or to the neurons.

Glucose used by the brain was tracked by calculating ratios of the amino acids serine, alanine and glycine to glucose, which allowed the assessment of rates of the vital steps involved in glycolysis.

The researchers identified that in comparison with samples of normal brain tissue, the enzyme activities that controlled those vital glycolysis steps were lesser in Alzheimer’s cases.

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Understanding the infinite area of medical device compliance

Understanding the infinite area of medical device compliance 1.pngWith a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic.

With the FDA being the sole regulator for this very vast area; it comes up with regulations, and expects medical device manufacturers to comply with them. This is part of the FDA’s primary function of assuring quality from medical devices. Compliance with these medical device regulations ensures that companies’ products meet the quality and safety and integrity of medical devices.

Areas of medical device compliance regulations

Understanding the infinite area of medical device compliance 2

The FDA’s regulation of medical devices and a few nonmedical devices cover the areas of manufacturing, repackaging, and relabeling, and/or importing. The regulations for medical devices are set out in 21 CFR Part 807, whose various sections detail all the requirements for compliance for Class I, II and III medical devices. The following are the activities connected with compliance for medical devices:

  • Registration of the establishment
  • Listing of the medical device
  • 510 (k)
  • Premarket approval
  • Investigational Device Exemption (IDE)
  • Quality Systems
  • GMP
  • Device labeling
  • Device reporting.

A thorough understanding of the FDA medical device compliance areas

Understanding the infinite area of medical device complianceThe ambit of the FDA’s regulations being very wide; it is important for medical device companies to have clarity on the many FDA medical device compliance regulations. This understanding will be offered at a seminar being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the areas of regulatory compliance.

The Director of this two-day seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc.

Please register for this webinar by visiting Understanding the infinite area of medical device compliance . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Helping to strategize compliance for medical devices

Understanding the infinite area of medical device compliance 3

Medical device companies need to put in place a sound strategy for medical device compliance. A certain level of strategic thinking alone ensures this. Susanne will show participants how to inculcate this thinking and instill it into the organization. She will show how to be cost-effective while improving the quality and compliance of medical devices. The ways of building a sound Quality System, which is at the root of medical device compliance; will be imparted.

An effective and efficient Quality System can only be implemented based on a thorough understanding of what the regulatory requirements mean, and adapting them into the Quality System. The ways of doing this will be the core of this seminar. Susanne will demonstrate the ways by which to plan, structure and implement a Quality System that addresses the specific business needs of the participants.

Addressing issues within a Quality System

Understanding the infinite area of medical device compliance 4

The methods for identifying, prioritizing and analyzing risks will be explained during the discussion on how to create a quality strategy and plans. Susanne will help participants explore the capabilities needed for every medical device to meet quality standards and implement compliant Quality Systems.

Also taken up for discussion are areas related to continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA), which are important components for addressing issues within a medical device company’s Quality System. Susanne will help with this very important aspect.

Over these two days, Susanne will also take up other crucial aspects of medical device compliance. These include:

  • Effectively communicating and escalating risk
  • Monitoring performance and progress
  • Kick starting the Quality System to avoid common problems such as MDRs, recalls, 483s, and Warning Letters.

Susanne will cover the following areas at this seminar on medical device compliance:

  • Quality System Expectations
  • Quality System Structure
  • Strategy and Planning
  • Risk management in your quality system
  • Case for Quality
  • Inspection preparedness and management
  • Monitoring and metrics
  • Creating a quality strategy and plans.

continue to improve the medical device compliance

 

GMP and Regulatory Expectations for Early IND Products

 GMP and Regulatory Expectations for Early IND ProductsWhat the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

These new guidelines appear to remove the need to follow GMPs for Phase I products; yet, this need persists in the Food, Drug, and Cosmetic Act. So, what can be said is that the need for GMP requirements for Phase I products has only been altered, not done away with. The nature of the investigational drug and the extent of the study that is planned will now determine the nature and extent of GMP-related activities.

A training session that will give complete understanding of these aspects

Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will offer complete clarity on all these points of GMP and regulatory expectations for early IND products at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Please visit GMP and Regulatory Expectations for Early IND Products to enroll for this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Advice on the GMP guidance document

GMP and Regulatory Expectations for Early IND Products3

At this seminar, Dr. Kuwahara will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. It will be a one-source course at which the regulations and guidelines that apply to early phase products will be presented. In a few cases, these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Dr. Kuwahara will present these items in the order of product development starting from the point of R & D activities and culminating in the completion of Phase 2 clinical trials.

GMP and Regulatory Expectations for Early IND Products1

Any pharmaceutical personnel who must deal with products both in early and later phases of development, will find this presentation highly valuable, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar. Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control will get a grasp of these aspects.

Over these two days, Dr. Kuwahara will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings.

 

To continue GMP updates

Video of father comforting newborn son receiving his first vaccines goes viral

Video of father comforting.jpg

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, he also continually reassured his son that he could cry if he needed to.

TEARS AS CONJOINED TWINS DIE DAY AFTER BIRTH

When it came time for the vaccinations, Lee held his son in his arms and told the little boy to “stay strong,” while Shamekia Harris, Lee’s girlfriend, recorded the visit on her phone. Little Debias did cry as the nurse gave him his shots, but stopped soon afterward when Lee consoled him.

The video has since gone viral, with about 13 million views, 51 thousand likes, and 186 thousand shares as of Wednesday.

Sadly, Lee’s father, Anthony Lee, 57, died that same day due to complications from drinking. Lee explained to People that he was emotional and very close to his father, and that he later spoke to his son Debias about his hopes for the future.

“I talked to him like a grown up … I told him, before I leave, want to see him succeed,” Lee said.

Lee wishes that the video will remind others of the importance of fatherhood, “I want them to take care of their kids, because when you sign up for something, you have to stick with it,” he told People.

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Lee, however, isn’t the only person to go viral for his vaccination video: In 2014, pediatrician Michael Darden gained attention for his unique approach to giving shots, and the video still doesn’t disappoint:

Read More: http://snip.ly/9obne#http://www.foxnews.com/health/2017/11/01/video-father-comforting-newborn-son-receiving-his-first-vaccines-goes-viral.html

IT’S A NO BRAINER! Action needed to stop children being exposed to chemicals that harm their brain development!

A report published today by CHEM Trust highlights how chemicals in food and consumer products used in homes, schools and offices could harm brain development in children.

The impacts – which may include ADHD and lower IQ – are avoidable and can prevent children reaching their full potential says CHEM Trust, in No Brainer: The impact of chemicals on children’s brain development: a cause for concern and a need for action.

Researchers have shown that many thousands of people have been exposed to now largely-banned chemicals such as lead and PCBs at high enough levels to have harmed their brain function. Now there is growing concern about the impacts of exposures to many of the ‘new’ chemicals in our 21st century lifestyles.

Chemicals of concern include brominated flame retardants (BFRs), a group of chemicals added to furniture, electronics and building materials, per- and poly- fluorocarbons (PFCs), used for non-stick coatings or breathable coatings in everyday products including packaging and clothes. Some chemicals in these groups are being phased out, but similar chemicals remain in everyday use.

The study also points out the unpleasant reality that children are constantly exposed to a cocktail of chemicals, which can act together, something which is still largely ignored by chemical safety laws.

CHEM Trust proposes a range of policies that could help address this challenge, for example faster regulatory action on groups of similar chemicals, and development of new methods for identifying chemicals of concern. They also include advice for consumers on how to reduce their exposure.

Dr Michael Warhurst, Executive Director of CHEM Trust, said:

“The brain development of future generations is at stake. We need EU regulators to phase out groups of chemicals of concern, rather than slowly restricting one chemical at a time. We cannot continue to gamble with our children’s health.”

The report has been peer reviewed by two eminent scientists in the field, Professor Philippe Grandjean and Professor Barbara Demeneix.

Prof Barbara Demeneix (Laboratory of Evolution of Endocrine Regulations, CNRS, Paris) said:

Chemical exposure is now at unprecedented levels, is multiple, ubiquitous, and present from conception onwards

Prof. Philippe Grandjean (Department of Environmental Medicine, University of Southern Denmark), added:

The current generation has the responsibility to safeguard the brains of the future
“I would insist that the Precautionary Principle must be applied in order to protect the next generation’s brains.”

 

Read More: http://snip.ly/maoou#http://www.chemtrust.org/brain/

 

The science of Sad: understanding the causes of ‘winter depression’

The science of Sad

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.

In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

Putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

The most popular treatments for Sad is bright-light therapy.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder

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