PDCs: A Vital Drop in the Ocean of Funding for Pediatric Devices.

This article is an in-depth examination of the role of pediatric device consortia (PDC) in the development of innovative devices. Looking at the funding model, and at how the challenges that arise in the development of medical devices differ from the development of drug therapies, the article looks at how PDCs can help OEMs with not only funding, but also expertise, regulatory guidance, and more. There is also an examination of some successful devices that have been backed by PDCs, and a comparison with how pediatric devices are funded in Europe to who how the true value of the FDA's PDC grant program.

Reversing the Innovation Pathway Could Be the Key to Cost-Efficient Health Care.

Throughout history, the world's biggest technological innovations have emerged from rich countries. Resource availability, economic prosperity that supports specialization in key areas of science and industry, and the concentrated centers of learning that such economies create all support this model. But history sometimes turns back on itself, and this is one of those moments.

Ensuring AI Is Helpful and Not Harmful in Health Care.

The presence of artificial intelligence (AI) is spreading fast through almost every industry, and health care is no exception. Data-based decision-making software is becoming pervasive in all facets of modern life, and the AI-enabled chatbot ChatGPT is having a seismic impact on the public perception of AI.

Double Vision: Study of U.K. Twins Provides New Insight Into Human Wellbeing.

Back in 1992, when Prof. Tim Spector of King's College London set up a study to investigate the incidence of osteoporosis and other rheumatologic diseases in monozygotic (identical) twins, little did he know how much the project would expand its horizons. From a few hundred identical twins, the cohort has grown to more than 15,000 identical and nonidentical twins across the U.K., aged between 18 and 100, and a host of diseases and conditions are under the microscope (Figure 1). Now, TwinsUK has one of the most deeply characterized adult twin cohorts anywhere in the world, providing vast quantities of data for longitudinal studies of health and aging.

DNA Testing for Preventative Health: Do Outcomes Justify Continued Investment?

In The U.K., a heated debate is raging in the genetics community about a not-so-new technology and its role in public health. Cheap genetic tests to discover our ancestry have become familiar consumer products, and our genes can tell us a lot about our ancestry, so it is an appealing idea that they can tell us about our susceptibility to serious diseases. Polygenic risk scores (PRS)-generated by sequencing multiple parts of a person's DNA-are said by some to hold the key to helping people avoid everything from type 1 diabetes to cardiovascular disease and cancer. This could herald a new era of preventive medicine, and the U.K. is investing heavily, but ultimately, whether or not this a good investment is still being determined.

An Injection of Innovation: How Drug Delivery Systems are Changing.

The market for injectable drugs is booming, fueling both a wave of innovation in device design and a debate about the relative pros and cons of injectables versus oral medication. As regulators continue to approve injectable medications that could replace daily pill regimens, particularly long-acting drugs that could improve patient compliance, it is legitimate to ask whether injectables will one day become the norm.

The Gene Editing Juggernaut is Picking Up Speed.

CRISPR-Cas9, the tool for editing genes by precisely cutting DNA and letting the body's natural DNA repair processes take over, deservedly led to Nobel prizes in 2020 for its pioneers, Emmanuelle Charpentier and Jennifer Doudna. Since their breakthroughs in 2012, the technology has moved forward in leaps and bounds, and techniques to manipulate genes that were once the realm of science fiction are becoming very much science "fact."

To Sleep, Perchance to Dream.

Most of us know the restorative value of an early night, so on some level we instinctively understand that sleep is good for both the body and the mind. Now, a growing body of research is starting to show just how vital sleep is to our overall health and longevity. Some believe that laughter is no longer the best medicine-sleep is.

Optogenetics: Using Light to Excite the Brain.

In 2005, Edward Boyden of Stanford University and Karl Deisseroth of MIT opened up a new field of research-optogenetics-that offered the potential to revolutionize the treatment of neurological conditions. Their quest to genetically encode brain cells to be photosensitive has unlocked a toolkit that researchers are adding to consistently, and the implications for neuroscience and neuroengineering are vast.

Wearable Tech Marks a Breakthrough for Scanning the Brain.

Today, the World Health Organization (WHO) reports that one in four people are affected by mental or neurological disorders, 50 m suffer from epilepsy, and 50 m from Alzheimer's disease. According to the Journal of Neurosurgery, 69 m globally have some type of traumatic brain injury. With these numbers rising daily, there is an urgent need to understand what is happening inside the brain. Brain scanning technology has advanced dramatically in recent decades, but it still faces significant limitations.

Has COVID Taught Us to be Better Prepared for the Next Pandemic?

Although it is too soon to say we have reached the end of the COVID-19 pandemic, scientists, politicians, and ordinary citizens are looking to the future and asking the same question-will there be another one? The simple answer is yes.

Is the End of Malaria in Sight?

Malaria is a disease that has plagued humanity since ancient times. Mentioned in Chinese scriptures from almost 5,000 years ago, and throughout Greek and Roman literature, it is caused by Plasmodium parasites, which infect humans through the bite of the infected female Anopheles mosquito. Though it is both preventable and curable, it kills hundreds of thousands of people every year.

Multi-center comparison of response to a single tablet of sumatriptan 85 mg and naproxen 500 mg vs usual therapy treating multiple migraine attacks as measured by the completeness of response survey.

OBJECTIVE: To investigate a broad definition of migraine resolution that extends beyond specific migraine-associated diagnostic symptoms as measured by the Completeness of Response Survey. METHODS: Conducted at 8 sites, 135 subjects treated migraines with SumaRT/Nap over 2 months. To measure subjects' experiences with SumaRT/Nap compared to their usual migraine medication, the Headache Impact Test, Revised Patient Perception of Migraine Questionnaire, and Completeness of Response Survey were administered at baseline and at 2 months. RESULTS: The effects of the study medicine compared to the subjects' usual migraine medicine reached statistical significance in decreasing headache severity, lessening of associated symptoms, and attaining complete relief with a single dose (60.04% of attacks resolved at 2 hours post-treatment). CONCLUSION: Compared to a subject's usual treatment, SumaRT/Nap used early and consistently for treatment of acute migraine offers important clinical improvements, including lessening of associated symptoms beyond International Headache Society criteria. CLINICAL TRIAL REGISTRATION NUMBER: NCT00893737.

Looking Disease in the Eye.

The eyes are said to be the windows of the soul, but they are increasingly the door to diagnostic information that could transform the lives of millions of people. Age-related macular degeneration (AMD), diabetic retinopathy, and glaucoma are the big three causes of permanent loss of vision, while severe neurological diseases like Alzheimer's and Parkinson's are on the rise. Thanks to new technologies for imaging the eye, the early signs of all of them can be detected earlier.

The PACE of Change Proteome editing could help treat diseases that antibodies and drug therapies cannot reach.

At a time when a global vaccine program is being rolled out at unprecedented speed, the world is more aware than ever before of the wonders of medical science. There are, however, many diseases that remain beyond the reach of modern medicine and the potency of some of our most widely used therapies are waning.

Healing Gets a Helping Hand.

The human body is miraculous in its capacity to heal but it can always use a little help. Wound care traditionally consists of little more than a protective barrier, possibly with an antibacterial agent, to cover the damage while the body works its magic. Now, a new technology has opened up a more active approach to encouraging healing.

Spellchecking for the Story of Life With CRISPR-Cas9 and Base, Prime Editors.

Just four letters-A, G, T, and C-make up the alphabet of the genome. It may seem simple, but a small difference in spelling can create mutations that result in life-threatening diseases. Gene variants that cause genetic diseases come in many varieties. Transition point mutations cause conditions such as progeria, the rapid aging disease. Transversion point mutations cause sickle-cell disease and other major disorders. Small insertions can cause Tay-Sachs, which stops nerves working properly and is usually fatal, and deletions can result in cystic fibrosis.

Chips Hold the Key to Reproductive Health.

Female reproductive medicine may not have been entirely overlooked in the history of medical research, but it has never been given the attention that it deserves. There are signs, however, that the spotlight is turning toward the most essential of human processes.

Landscape genetics of California mule deer (Odocoileus hemionus): the roles of ecological and historical factors in generating differentiation.

Landscape genetics is an emerging discipline that utilizes environmental and historical data to understand geographic patterns of genetic diversity. Niche modelling has added a new dimension to such efforts by allowing species-environmental associations to be projected into the past so that hypotheses about historical vicariance can be generated and tested independently with genetic data. However, previous approaches have primarily utilized DNA sequence data to test inferences about historical isolation and may have missed very recent episodes of environmentally mediated divergence. We type 15 microsatellite loci in California mule deer and identify five genetic groupings through a Structure analysis that are also well predicted by environmental data. We project the niches of these five deer ecotypes to the last glacial maximum (LGM) and show they overlap to a much greater extent than today, suggesting that vicariance associated with the LGM cannot explain the present-day genetic patterns. Further, we analyse mitochondrial DNA (mtDNA) sequence trees to search for evidence of historical vicariance and find only two well-supported clades. A coalescence-based analysis of mtDNA data shows that the genetic divergence of the mule deer genetic clusters in California is recent and appears to be mediated by ecological factors. The importance of environmental factors in explaining the genetic diversity of California mule deer is unexpected given that they are highly mobile species and have a broad habitat distribution. Geographic differences in the timing of reproduction and peak vegetation as well as habitat choice reflecting natal origin may explain the persistence of genetic subdivision.

The Human Touch: Practical and Ethical Implications of Putting AI and Robotics to Work for Patients.

We live in a time when science fiction can quickly become science fact. Within a generation, the Internet has matured from a technological marvel to a utility, and mobile telephones have redefined how we communicate. Health care, as an industry, is quick to embrace technology, so it is no surprise that the application of programmable robotic systems that can carry out actions automatically and artificial intelligence (AI), e.g., machines that learn, solve problems, and respond to their environment, is being keenly explored.