Archive For The “Israeli Medicine” Category
Move over mindfulness meditation. Neuroscience is now beginning to map what’s going on inside your brain when you’re feeling good, and not-so-good, to help promote mental and emotional wellness. It’s a logical augmentation of mindfulness meditation which has become very popular recently although it’s been around for thousands of years.
The remainder of this post was originally reported by NoCamels.com
Brain researchers across the world are increasingly beginning to study the link between our body’s control center and emotional health. In recent years, neurological wellness (or neuro-wellness), an emerging field focused on emotional wellbeing, mood enhancements and innovation and technology, has also garnered attention.
“Because we’re living longer, our focus is starting to shift toward well-being,” Bill Gates wrote last month as part of a piece reflecting on technological breakthroughs for the MIT Technology Review. “I think the brilliant minds of the future will focus on more metaphysical questions: How do we make people happier? How do we create meaningful connections? How do we help everyone live a fulfilling life?”
Earlier this month, this question was one of the main focuses at the Fourth International BrainTech Conference in Tel Aviv, a two-day global meeting point for leading scientists, clinicians and entrepreneurs who engage in brain research and technology.
While the power of a positive mindset has been praised as key, there is emerging scientific backing for the thesis that mood is directly linked to the mental processes in our brain. Moshe Bar, director of the Leslie and Susan Gonda Multidisciplinary Brain Research Center at Bar-Ilan University, presented a study that found that optimistic people show better cognitive work on associations, creativity, memory and a broader scope of attention than those with a more depressed outlook. People with a positive mindset, he indicated, are better able to foresee what’s coming next and to minimize perceived uncertainty. Thus, improving the mood of individuals can prompt our brain to activate processes that will make us feel well.
The brain’s powerful capacities are well documented, but can the mind heal the body? Neuroscientists Dr. Talma Hendler, of Tel Aviv University, and Dr. Asya Rolls, of the Technion, are currently collaborating on a study on brain-body interaction. Their initial findings have shown that activating a neural mechanism in our brain’s reward system may boost the immune system.
Can technology support us emotionally? More and more entrepreneurs recognize the potential of such evidence for transforming our mind and body. Products for emotional wellness are currently flooding the market. But can technology really support us emotionally?
“Yes,” says Nichol Bradford, executive director and co-founder of The Transformative Technology Lab (USA), who believes that we are standing at the threshold of a new era of human flourishing. “I think there is a great deal of range and possibility in using technology to teach us how to relate to the way we feel. Emotions and self-regulation are trainable and teachable skills,” she tells NoCamels.
According to Bradford, transformative technologies for well-being will not only address mental health and happiness, they are also entering the future of workplaces, improving emotional intelligence and social skills. Ultimately, they will lead to enhanced mental and emotional capacity.
Bradford calls this the “future of human possibilities” in which technology helps people develop their full potential. “The point is … to establish a new level of mental and emotional health.“
An example of this is TRIPP, a Los Angeles-based software company that developed a mood-on-demand platform powered by virtual reality. Like a combination of video games and meditation, “taking a ten-minute TRIPP” can puts users in a state of mindfulness by creating a deep immersive, brain-stimulating experience. CEO and co-founder Nanea Reeves believes that mental health is the market for VR. After launching their product for corporate wellness programs, the company’s goal is to enter the therapeutic market, where TRIPP could be used for treatments like addiction recovery, he tells NoCamels.
An Israeli product that has already been deployed in hundreds of clinics worldwide is Myndlift, a device for personalized neuro-therapies. When looking for ways to improve ADHD symptoms without medication, Myndlift CEO Aziz Kadan discovered the potential of neurofeedback. Combining a sensory headset with a training program, Myndlift responds to changing brainwave patterns and is able to change and balance brain activation. The devices were featured at the conference.
Meanwhile, NYX Technologies, a young Israeli neurotech startup, is developing a platform for sleep management and stress reduction. A headset reads a user’s brain patterns and adapts its function individually for falling asleep faster, getting into deeper sleep and waking up refreshed. Currently, the Haifa-based company is conducting beta tests.
Israeli Biotech company Bonus Biogroup has created
The following excerpts were first reported by NoCamels.com.
When Danny Yaakobson, an extreme sports enthusiast, suffered a serious leg injury following a car accident two years ago, he did not imagine he would become the world’s first patient to receive a lab-grown bone implant made from his own fat cells to replace a missing section of his shinbone, let alone take part in an Israman triathlon just a year following the surgery.
But that is exactly what happened. While traveling abroad in 2017, Yaakobson suffered a road accident and nearly lost his whole leg. The injury was serious and painful, he says, but his doctor told him about a clinical trial that would change the course of his life.
“The doctor said that there wasn’t much to lose anyway [in participating in the clinical trial], that the situation was not so good as it was,” Yaakobson explains in a video interview provided by Bonus BioGroup.
During the process, human fat tissue is extracted from the patient. Bonus BioGroup then separates the various types of cells and isolates the stem cells. The stem cells are removed and stimulated in a bioreactor, a special device that simulates the body’s environment and provides suitable conditions for bone generation. The fat cells are then grown in a lab until the tissue becomes solid, after which the hardened bone tissue is injected back into the patient’s body.
Bonus BioGroup CEO Dr. Shai Meretzki says in a video interview that “currently an autologous [cells or tissues obtained from the same individual] transplant is the gold standard for treating patients who lose bones for a wide variety of reasons. In order to perform the process you need to harvest the bone for one location within the body. Usually you cut from the femur and move it to the cut location, which is a very hard, expensive, painful and difficult process.”
“What we are offering instead is a completely new approach to patients who have lost their bones for the most disparate reasons, growing the old bone outside of the human body within a relatively short time,” Meretzki says.
The surgery to replace a missing 2 inches (5 centimeters) of
Israeli Medtech startup Zebra Medical brings artificial intelligence (AI) to automatically detect brain anomalies. It’s like the optical character recognition (OCR) used to recognize words or other symbols when scanning a document. That’s basically how
The following content was first reported by NoCamels.com
Israeli startup Zebra Medical Vision will begin deploying its revolutionary medical imaging AI solutions in one of Israel’s largest hospitals, Tel Aviv’s Ichilov, as well as with Clalit Health Services and Maccabi Healthcare Services – Israel’s largest and second-largest HMO, respectively. The three medical entities manage some 90 percent of patients in Israel, the company said in a statement.
Zebra Medical said it received government support through grants from the Israel Innovation Authority for these projects, but did not disclose financial details.
See related story on artificial intelligence.
The company, founded in 2014 by Eyal Toledano, Eyal Gura, and Elad Benjamin, uses AI to read medical scans and automatically detect anomalies. Through its innovative development and use of 11 different algorithms, Zebra Medical can identify visual symptoms for diseases such as breast cancer, osteoporosis, fatty liver, and conditions such as vertebral fractures, aneurysms, and brain bleeds.
At Ichilov, also known as the Tel Aviv Sourasky Medical Center, which runs Israel’s largest ER section, the technology will prioritize radiologists’ worklists by scanning entire queues and flagging those that need immediate attention, thereby allowing those with life-threatening issues to be attended to more quickly.
“Emergency room patients will have their cases prioritized by AI, and if a CT scan includes a brain bleed or if a chest x-ray contains an acute condition such as pneumothorax, the patient’s imaging scan will be prioritized and placed at the top of the radiologist’s list for review, leading to earlier initiation of treatment,”wrote Eyal Gura, Zebra Medical Vision’s co-founder and CEO, in a post announcing the partnerships.
Women who are members of the Maccabi HMO and patients of its private medical centers, meanwhile, may undergo their annual mammography exams where both expert radiologists and AI algorithms review the scans. This is in a bid to increase chances of any cancer detection earlier, and reduce unnecessary biopsies and risks of misdiagnoses.
“Traditional Computer Assisted Diagnosis (CAD) technologies failed in the past by exposing too many false positives and we are hopeful that AI can bring new insight to the process of the ‘second-reading’ of scans,” Gura wrote.
At the Clalit HMO, Zebra will apply its technology to detect early signs of osteoporosis and heart disease in patients and alert physicians who can then apply preventative treatments.
Gura explains that the benefits will also apply to caregivers, who can work more effectively and quickly to provide care, and to the state which can manage a better healthcare budget and
“Every patient with an undetected acute condition such as brain bleed, pneumothorax, or other undetected conditions such as breast cancer, ends up (in the best case scenario) with more days hospitalized, requiring more expensive treatments, with more working days lost and a greater lack of productivity for his or her surrounding family and direct contacts,”Gura wrote.
Gura said the company was “humbled by the opportunity” and remained
“committed to providing the best solutions to our local care providers”
“In 2020, the majority of the people around us, including our loved ones, will be impacted by the tools we are creating,” he said in the company statement. “There is nothing more satisfying than that for our team.”
The Israel Innovation Authority’s CEO Aharon Aharon said the government agency “believes digital health to be of imperative and strategic growth engine for the entire Israeli economy,” and that Zebra Medical Vision’s participation in the program “represents the flagship that will help[…] substantiate and promote digital health in Israel.”
Professor Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center, said: “As a global leading ER center, we put significant emphasis on being on the cutting edge in terms of technology solutions that will empower our team. We selected Zebra-Med’s AI solutions to help our team perform faster and better diagnostics and we are certain that hundreds of thousands of patients will benefit from this new technology.”
Zebra Medical has seven CE marks for its various algorithms and 510(k) FDA clearance for one of them. It has raised over $50 million in venture funding since it was established five years ago.
In 2017, Zebra Medical partnered with multinational tech giant Google to provide its algorithms on Google Cloud, so hospitals and medical professionals in the US can access the service for $1 per scan. The company says its data and research platform has already yielded AI imaging insights for millions of scans.
The award-winning company has also been recognized as particularly innovative by Business Insider, Forbes, and Fast Company.
The more marijuana is put under the microscope, the more benefits become evident. The latest comes from an Israeli study showing that marijuana reduces symptoms in children suffering from Autism
The remainder of this article was originally reported in NoCamels.com
A new Israeli scientific study has shown that the use of medical cannabis in children under 18 diagnosed with autism spectrum disorders (ASD) can relieve common symptoms such as seizures, disruptive behaviors, depression, and restlessness.
ASD is a range of neurological disorders that affect communication, behavior, and social skills, and for which there is no specific treatment. According to the World Health Organization, it affects 1 in 160 children worldwide and over the past three decades, there has been a 3-fold increase in the number of children diagnosed, according to the study. Interventions often focus on intensive behavioral therapies that require high levels of care.
The Israeli study was conducted by researchers from Ben-Gurion University of the Negev (BGU) and the Soroka University Medical Center, among them Professor Raphael Mechoulam, the renown organic chemist who in 1964 was the first to identify cannabis’ THC compound, the chemical known for causing a “high.” Mechoulam is credited with laying the foundation for scientific research on cannabis and its use in modern medicine.
In the new study, titled “Real life Experience of Medical Cannabis Treatment in Autism: Analysis of Safety and Efficacy” and published in the scientific journal Nature…
researchers found that over 80 percent of the parents of the children in the study reported significant or moderate improvement in their child.
The treatment in the majority of the 188 child patients was based on cannabis oil containing 30 percent CBD (Cannabidiol, a non-psychoactive chemical produced by the cannabis plant) and 1.5 percent THC.
All the children in the study, ranging in age from under 5 to 18, were previously diagnosed with ASD by certified neurologist or psychiatrist, as required by Ministry of Health prior to the initiation of the cannabis-based treatment.
The patients were assessed before the cannabis oil treatment, after a month of treatment, and after six months of treatment.
After a month, with 179 patients, 58 patients (48.7 percent) reported significant improvement, 37 (31.1 percent) moderate improvement; 7 patients (5.9 percent) experienced side effects and 17 (14.3 percent) reported that the cannabis did not help them. The side effects they reported included sleepiness (1.6 percent), bad taste and smell of the oil (1.6 percent), restlessness (0.8 percent), reflux (0.8 percent) and lack of appetite (0.8 percent).
After six months, with 155 patients and 93 respondents to a follow-up questionnaire on the treatment, 30.1 percent reported significant improvement, 53.7 percent moderate improvement, 6.4 percent slight improvement, and 8.6 percent said that saw no change in their condition.
The patients also reported that after 6 months of treatment, their quality of life improved (66.8 percent) and 63.5 percent noted a more positive mood. There was also a marked improvement in the ability to dress and shower independent (42.9 percent) and sleep better (24.7 percent).
True. Good ole Aloe Vera does a great job for the occasional burn from a hot stove, or the many scrapes kids seem to attract. The natural bovine treatment of Colostrum also does a bang up job for all types of open wounds. But until now, severe burn victims had to undergo months (if not years) of painful bandage wraps.
The new wound care treatment has a few advantages over traditional wound treatment. For starters, the treatment never touches the wound which reduces infection. In addition, no bandages are needed. Anyone who has undergone large scale burns know all-too-well the pain and suffering of having their bandages applied and basically ripped off the skin on a daily basis.
The following content was originally reported by NoCamels.com
Israeli-developed laser technologies are also sought after to help reduce the devastating impact of scars in burn victims.
“This is one of the birthplaces of laser medicine. You have doctors here who think innovation, it’s in their blood. It is a very exciting environment to work in,” US-based Burn Advocates Network founder Samuel Davis, tells NoCamels.
Davis was in town this week for the inauguration of the Israel Pediatric Aesthetic and Reconstructive Laser Surgery Center of Excellence (I-PEARLS), which he founded to be part of the National Burn Center at Sheba Medical Center.
Prof. Josef Haik, the Director of Israel’s National Burn Center Intensive Care Unit at Sheba Medical Center, and Prof. Arie Orenstein, director of the Sheba Medical Center Department of Plastic and Reconstructive Surgery, worked closely with Davis to develop this first center in the Middle East focused on non-invasive methods to heal scars.
In Israel, burns are the most common injuries among children (and especially in winter), according to the Ministry of Health. In 2017, 3,286 children were treated for burn wounds at emergency wards and Terem clinics, according to the latest data by the Ministry of Health
“Laser treatments have been around for years but somehow kids with burn scars got left out of the focus. When you take innovative clinicians and you put them together with the latest equipment, good things happen,” says Davis, a philanthropist from New Jersey who is also the founder of Camp Sababa, Israel’s camp for pediatric burn survivors.
“Sheba has a tradition of bringing catastrophic burn cases from Greece, Syria, Africa, the Palestinian Authority areas and from all over the region. This will just increase and expand the ability of the doctors to accept patients and teach physicians and surgeons in foreign countries. It increases the capability of Sheba to do its mission,” says Davis. “The center is already training doctors from other countries and we’re laying the groundwork to export I-PEARLS techniques.”
Indeed, Israel’s name as an innovator in the burn treatment space is sought out, agrees Barak, of Nanomedic.
“Israel is a source of a lot of innovation. All the physicians and companies with whom we’ve been in touch appreciate the innovative approach we have here,” she says.
We originally reported on this cancer cure story a few weeks back. Subsequently, a lot of red flags started appearing about the AEBi (Accelerated Evolution Biotechnologies, Ltd), including:
- The cancer cure would be available from day one and the subject will be completely cancer free within a year.
- That AEBi offered no evidence for its claim, only that they did not have enough funding to produce peer-reviewed publications.
- laims to be able to cure all forms of cancer.
- A notable cancer research scientist reported in a Forbes that the AEBi claimed to attack cancer cells three at a time, which is strange since cancer cells themselves can’t do that.
The following excerpts were originally reported by NoCamels.com
The new development was picked up by numerous media publications in Israel and across the world. Meanwhile, AEBi offered no evidence of its findings and claimed not to have the funds to publish any in peer-reviewed scientific journals.
But the company says its developed treatment, MuTaTo (multi-target toxin), is a new, multi-pronged attack on cancer cells using peptides that showed “consistent and repeatable” results in the “first exploratory mice experiment, which inhibited human cancer cell growth and had no effect at all on healthy mice cells, in addition to several in-vitro trials,” the Jerusalem Post reported.
Dr. Victoria Forster, a cancer research scientist and postdoctoral fellow at The Hospital for Sick Children (SickKids) in Toronto, Canada, wrote in a Forbes piece that the first “red flag” for her was a claim by AEBi’s CEO Dr. Ilan Morad on what the treatment could achieve.
“Instead of attacking receptors one at a time, we attack receptors three at a time – not even cancer can mutate three receptors at the same time,” Morad had told the Jerusalem Post.
“This is categorically untrue,” wrote Forster. “Cancers can have anywhere from one to tens of thousands of DNA mutations in their genomes, many of these being the ‘receptors’ Morad vaguely refers to. A key principle of using multiple chemotherapy agents at once is to go after cancer cells by several different routes to reduce the chance that they will become resistant. Still, many cancers do become resistant to these treatment protocols, so Morad’s logic here is extremely shaky.”
Furthermore, the Israeli company’s claim that its treatment will work for all types of cancers is also a “huge red flag,” she said.
“There are broadly over 200 different types of cancer and within those, multiple other subtypes. For there to be one, universal ‘cancer cure’ that overcomes all of these differences is highly unlikely,” Forster charged.
An Australian cancer research scientist went a step further, accusing the company of “selling unicorns” and calling for it to be hung out “to dry for making such cruel and misleading claims.”
In reference to popular culture, cancer biologist Dr. Darren Saunders said
Dr. J. Leonard Lichtenfeld, the deputy chief medical officer for the national office of the American Cancer Society, wrote in a blog post titled “A Cure For Cancer? Not So Fast” that while the Israeli scientists “worked with an interesting approach to interfering with the ability of cancer cells to function,” they provided very limited information that has “not been published in the scientific literature where it would be subject to review, support and/or criticism from knowledgeable peers.”
He further noted that AEBi’s initial experiment on mice in clinical trials “is not a well-established program of experiments which could better define how this works—and may not work—as it moves from the laboratory bench to the clinic.”
“The gap from a successful mouse experiment to effective, beneficial application of exciting laboratory concepts to helping cancer patients at the bedside is, in fact, a long and treacherous journey, filled with unforeseen and unanticipated obstacles,” Lichtenfeld wrote, pouring cold water on the claim that the treatment would be available in a year.
Who would have thunk it. Israeli farmers lining up to grow pot. You are not living in some alternative universe. That’s what’s going on right now in Israel. And the government is supporting the initiative which it expects to generate $1billion in exports per year, and that’s even with a cannabis-hostile Trump administration.
The following text was originally reported in NoCamels.com.
According to Israeli government research, medical cannabis exports is set to bring in an estimated $1 billion in revenue per year. Since the government announced the reforms two years ago, some 400 Israeli farmers applied for permits to grow cannabis, the Israeli Health Ministry said last year, with another 242 receiving preliminary approval. The ministry also said it received some 200 applications for cannabis nurseries seeking to distribute cannabis plants, 95 requests to set up cannabis pharmacies, 60 applications for processing facilities, and 44 requests to set up stores selling cannabis products.
The medical cannabis exports law hit a snag last year when Prime Minister Benjamin Netanyahu, much to the dismay of the local industry, froze export plans amid political wrangling and opposition by the Ministry of Public Security headed by Gilad Erdan which said it was afraid plants grown for exports would spill over into the recreational market, and demanded some NIS 200 million to its budget to help secure facilities. A reported conversation with US President Donald Trump, whose administration is taking a hard line against cannabis including its medical use, was also said to be the cause of the sudden export freeze.
The revised law provides a budget for police to monitor, track and control the production and delivery of cannabis for export, and prevent said spill over. Recreational use of cannabis in Israel is still not legal but licensed medical cannabis consumption for vetted physical and mental health issues has been allowed for a decade.
The law also specifies that any foreign investment of more than five percent in an Israeli cannabis company will require regulatory approval.
We already have smartphone apps to check heart rates, blood pressure, and other vital signs. So why not a device, a very nonintrusive device that can detect diseases without having to undergo intrusive, stressful, and expensive medical testing? That’s exactly what Israeli researcher Hossam Haick has created.
The remainder the this text was originally published by NoCamels.com
Israeli Professor Hossam Haick of the Wolfson Faculty of Chemical Engineering at the Technion – Israel Institute of Technology was awarded the European Commission Innovation Prize last week for his invention of the SNIFFPHONE, a device that uses nanotechnology sensors to analyze particles on the breath and is able to pinpoint to exact diseases, like certain kinds of cancer, pulmonary and even the early stages of neurodegenerative diseases.
Haick was awarded the prize last week in Lisbon, Portugal at the annual European Forum of Electronic Components and Systems (
The SNIFFPHONE includes the NaNose, developed in 2014 by Haick and Professor Nir Peled of Tel Aviv University’s Sackler Faculty of Medicine. It is a microchip incorporated into a the breathalyzer-like device, capable of diagnosing various diseases. The device uses the presence of specific volatile organic compounds, which are unique fingerprints for various forms of diseases.
“We look for what are called volatile organic compounds, or biomarkers, on the breath. These biomarkers are chemical compounds that are imitated from the source of the disease and, as a result, are diffused within the bloodstream. Of course, the bloodstream is in contact with the skin and the lungs, which is why our test is able to detect them,” Haick told NoCamels in 2015.
In a 2017 study led by Haick and which involved 1404 participants from five countries, the NaNose was able to differentiate between malignant and benign tumors, as well as their source, with almost 90 percent accuracy.
The SNIFFPHONE and NaNose are among a long list of achievements for the award-winning scientist. He holds dozens of patents and made it into a number of notable lists, including the “World’s 35 leading young scientists” by the MIT Technology Review for his research in non-invasive disease detection methods, and a list of 100 most influential inventors by several international agencies between 2015-2018.
The European Commission previously awarded him $6.8 million for further development of the NaNose.
He’s also won an array of prizes and medals, including Knight in Order of the Academic Palms by the French Government, the Humboldt Award, the Bill and Melinda Gates Prize and the Herschel Ritz Innovation Award.
He currently serves as faculty and F.M.W. Academic Chair in the Department of Chemical Engineering at Technion and serves as a consultant to several commercial companies that spun out of his laboratories at the prestigious university.
His latest work, alongside Technion postdoctoral researcher Weiwei Wu, involves wearable health devices that include electrodes and sensors applied onto nylon textiles and permeable skin-mimicking bandages that constantly monitor breath rate, skin odor and chemical biomarkers (saliva, sweat). Specific irregularities in these parameters can indicate the presence of a disease, according to the research results published in Advanced Materials this year.
SEE ALSO: Technion Scientist Invents New Wearable Health System For Detecting Disease
Though certain technologies already possess these capabilities, Haick’s devices set themselves apart through self-sustainability. In particular, the gadget hopes to use cutting-edge materials that heal themselves and take advantage of the body’s wasted energy. Its components harvest the energy of body heat and movement, and they use synthetics that regenerate its properties upon damage. These advances alleviate risks such as leaving a device uncharged, torn or scratched. This technology will increasingly improve the quality of life through becoming a remote nurse that constantly accompanies an individual, according to the researchers.
Due to the constant monitoring of an individual’s vitals, these sensors provide a diagnosis of diseases in early stages. This prevents diseases from progressing, which Haick cites as a motivation for his research. “The results are very encouraging,” Haick told NoCamels this summer, pointing to recent testing done on tuberculosis screening using sensors integrated into bandages. Among the standard “healthy” ranges set for the devices are 60 to 100 heartbeats and seven to eight breaths per minute.
However, the product is only in its preliminary stages. According to Haick, though the discrete devices exist, the sensor and energy units are yet to be integrated into one product. Currently, the research team awaits a patent on a breathable self-healing platform imitating skin. Although his research team waits for further results, Haick states he is already seeking investors for what he calls a “promising and prospective technology.”
The wearable health device sector has tremendous potential. Experts predict this market will reach nearly $20 billion by 2021. Not only do these technologies monitor a patient’s vitals, they also facilitate communication between patients and healthcare professionals around the clock and reduce the cost of human labor associated with constantly checking patients.
Haick’s research group is also working on other related projects. Notably, the team is developing self-repairing multipurpose health monitors that resemble tattoos imprinted on skin. This device will make use of a field-effect transistor (FET), which can modify its behavior through a varying electric field.
According to Wikipedia, drug overdoses have become the leading cause of death of Americans under 50, with two-thirds of those deaths from opioids. In 2016, the crisis decreased
The opioid epidemic or opioid crisis is the rapid increase in the use of prescription and non-prescription opioid drugs in the United States and Canada beginning in the late 1990s and continuing throughout the next two decades. The increase in opioid overdose deaths has been dramatic, and opioids are now responsible for 49,000 of the 72,000 drug overdose deaths overall in the US in 2017. The rate of prolonged opioid use is also increasing globally.
The remainder of this text was originally published by NoCamels.com
According to the FDA, Brainsway is set to develop a device for opioid use disorder therapy. The seven other companies, a majority US-based, will develop systems for pain therapy, medication dispensation, overdose detection, drug screening, and virtual reality (VR) treatments for chronic pain.
Medical devices at any stage of development were eligible for the challenge.
The opioid crisis in the US has garnered international attention for its startling statistics. According to the US National Institute on Drug Abuse, 115 Americans die every day from an opioid overdose.
More than 40 percent of all US opioid overdose deaths in 2016 involved a prescription opioid, according to the Centers for Disease Control and Prevention. Overdose rates from prescription opioids were highest among people aged 25 to 54 years, according to the report. And based on data from Substance Abuse and Mental Health Services Administration’s national survey on drug use and health, 11.1 million people aged 12 and older had misused prescription pain relievers in 2017.
The eight companies selected for the FDA innovation challenge will work closely with the agency to “accelerate the development and expedite marketing application review of innovative products, similar to what occurs under the Breakthrough Devices Program“, which helps expedite “certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.”
The companies will enter a 90-day collaboration to develop mutual understanding of the product profile including the patient and user needs, and the important risks and benefits, and to discuss the potential regulatory pathways going forward.
“While these products will not automatically receive marketing authorization from the FDA, the device developers will receive increased interaction with CDRH experts, guidance for clinical trial development plans, and expedited review,” wrote Drs. Jeffrey Shuren and Jonathan
“We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications,” they wrote.
The CDRH has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies…which may reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain, they said.
Brainsway was founded by Abraham Zangen, Yiftach Roth, Avner Hagai
The ubiquity of
The remainder of this text was excerpted from full-length published article in NoCamels.com
For decades, Israel has been an established world leader in medical cannabis R&D, due to the pioneering work of Hebrew University of Jerusalem Professor Raphael Mechoulam. In 1964, the renown organic chemist was the first researcher to identify cannabis’ THC compound, the chemical known for causing a “high,” laying the foundation for scientific research on cannabis and its use in modern medicine.
In the years since, Israel became among the few countries with a government-sponsored medical cannabis program, and was the first in the world earlier this year to approve a vaporizer as a medical device for the use of cannabis extracts and formulations.
Though the country’s efforts to lead in other areas – like its big plans to become a top medical cannabis exporter with an estimated $1 billion in revenue per year – have stalled due to political wrangling, Israeli cannabis startups have stepped ahead with cutting-edge, smart devices and products for cannabis cultivation, consumption, measurement, and storage.
And their sights are set on the global cannabis market, expected to be worth some $32 billion by 2022.
Oren Todoros, CEO of the branding firm CannaImpact, tells NoCamels that mixing cannabis culture with IoT (the internet of things) “has the potential to lift the industry to new heights.”
“Due to this rapid shift towards smart connected devices, growers and consumers are increasingly turning to IoT technologies, essentially comprising of sensor devices, artificial intelligence (AI) and data analytics, to bring new efficiencies to the way we grow and consume cannabis,” says Todoros, whose firm works with Israeli startup Kassi Labs, which developed a smart storage hub solution for marijuana.
Yona Cymerman, a co-founder of Can Innovation Finder (CIF), a new initiative that hopes to connect North American cannabis growers with blue-and-white tech solutions, says “the licensed producers we work with are always interested in hearing about innovative designs and technologies being developed to improve the consumer experience, and have expressed a lot of interest in devices and gadgets.”
“Israeli entrepreneurs have demonstrated great creativity in developing and designing their products, adopting concepts from other industries such as the sports market, and are aware of, and investing in the aesthetics of their products, which makes them all the more attractive for investment purposes,” she tells NoCamels.
From vaporizers and inhalers to growing environments and all-in-one storage solutions, we’re taking a closer look at seven companies that developed forward-looking “smart” gadgets for a next-generation cannabis experience and data analysis.