How NeuroMetrix seeks to better relieve pain with AI

NeuroMetrix Quell 2.0 AI artificial intelligence pain relief

NeuroMetrix’s Quell 2.0 [Image courtesy of NeuroMetrix]

NeuroMetrix plans to add artificial intelligence to the latest iteration of its Quell transcutaneous electrical nerve stimulation (TENS) device.

AI will allow Quell 2.0 to tailor treatment to each individual user, according to the Waltham, Mass.–based based company.

Launched in September 2018 Quell 2.0 is 50% smaller and 20% more powerful than the original Quell, which debuted in 2015. Quell is worn on the leg regardless of the site of pain and is designed to send neural pulses to the brain that trigger a natural pain relief response in the central nervous system. Patients control the device and track their pain using a smartphone app. Quell 2.0 is available over-the-counter for about $300.

So how could AI help patients who use the device? NeuroMetrix chief commercial officer Frank McGillin recently discussed the decision to use AI and the future of Quell with our sister site Medical Design & Outsourcing.

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Medtronic risk prediction tool could help prevent opioid deaths: Here’s how

Medtronic logo updatedMedtronic officials continue to hone their arguments for how the company’s capnography and oximetry systems could reduce potentially deadly opioid-induced respiratory compromise.

The medical device giant on Feb. 17 announced preliminary results of its Prodigy study, in which the company’s Microstream and Nellcor monitoring technology provided continuous capnography and oximetry for 1,496 patients across 16 sites in the U.S., Europe and Asia.

The study resulted in what Medtronic says is an easy-to-use risk prediction tool. Called the Prodigy score, it helps identify patients on the hospital general care floor who are taking opioid medications and are at high risk of developing a respiratory compromise.

The score takes into account variables including age, gender, sleep disorders, chronic heart failure and opioid naïvety. During the Prodigy study, it identified more than three-fourths of patients with confirmed respiratory depression.

Overall, opioid-induced respiratory depression occurred in nearly half of the patients in the study.

“Clinical evidence shows that acute and unexpected respiratory compromise on the general care floor is increasingly common. Until now, we have not been successful in predicting which patients are at high risk when recovering on the general care floor,” said Dr. Ashish Khanna, the primary study investigator and an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine.

“These data validate an easy-to-use [opioid-induced respiratory depression] risk prediction tool to identify patients at the highest risk and guide early intervention using continuous capnography-based monitoring. Early identification and intervention in these high-risk patients has the potential to improve patient safety and decrease the economic and clinical burden of unplanned ICU admissions,” Khanna said in a news release.

Opioid-induced respiratory depression is a “common, costly and deadly but preventable condition,” and Medtronic through the Prodigy study is committed to help, said Vafa Jamali, SVP and president of the Medtronic’s respiratory, gastrointestinal and informatics business.

“We are encouraged by the data demonstrating the use of the Prodigy OIRD risk prediction tool,” Jamali said. “It can help clinicians prioritize resources by identifying those patients at highest risk on the general care floor who should be continuously monitored with capnography and pulse oximetry.”

 

 

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5 top stories that mattered for medtech in 2018

medtech medical devices 2018

[Image by managing editor Chris Newmarker]

The medical device industry faced some major challenges over the past year, from increased media scrutiny to regulatory uncertainty in both the U.S. and E.U.

It’s worth noting, though, that many things have been going right for medtech.

More than half of the roughly 100 largest medical device companies in the world saw their stock prices increase during 2018 – not a bad record considering the slumping Dow Jones Industrial Average and S&P 500.

Medical device companies spending a large amount on R&D compared to revenue – including Dexcom, Abiomed, Atricure, Edwards Lifesciences and Insulet – saw their stock prices skyrocket as they marketed innovative devices in fields including diabetes management and cardiology.

Artificial intelligence is playing a larger role in medtech innovation, medical device companies are increasingly forging partnerships with high tech companies, and there’s even a chance that the device industry might help combat the opioid epidemic.

Here are five trends that mattered for medtech in 2018 – and are bound to influence the future of the industry this year.

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The top 10 medical disruptors of 2019

medical-disruptors-2019

[Image from unsplash.com]

The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year.

The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150.

After that, 20 physicians meet and vote the list down to the top 10. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year.

The Cleveland Clinic announced this year’s top 10 list at its Cleveland Clinic Medical Innovation Summit, which took place Oct. 22-24 in Cleveland. From RNA-based therapies to alternative pain therapy to fight the opioid crisis, here are the Cleveland Clinic’s predictions of medical technologies that will prove disruptive in 2019.

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Medtech reporting would change under new opioid law

A section of the recently-passed bill to address the opioid crisis could have implications for medtech.

The 250-page Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act) contains a provision that would require manufacturers of certain medical devices, drugs and biologics covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value made to “covered recipients.”

“Covered recipients,” as originally written in the sunshine provision of the Affordable Care Act, were only physicians and teaching hospitals. Section 6111 of SUPPORT would expand that to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives as of January 1, 2022. Also known as H.R. 6, the bill has passed both houses of Congress and is awaiting President Trump’s signature.

The reporting changes needn’t have anything to do with opioids, and this provision’s effective date is ambiguous, according to an FDA law blog post by the Washington, D.C. law firm Hyman, Phelps & McNamara. Stay tuned for CMS to clear this up in forthcoming regulations.

 

 

 

 

 

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House Passes SUPPORT for Patients and Communities Act to Combat America’s Opioid Crisis

Opioid abuse and addiction in America has reached epidemic heights. As a nation, we’re spending more than $500 billion annually in health and social costs to combat this growing problem. What’s more, the Department of Health and Human Services reports more than 40,000 lives lost in 2016 from overdosing on these pain management treatments.

Long-term solutions to combating this crisis will depend upon biomedical innovation and the development of novel and safer, next generation therapies to treat both pain and addiction.

Last week, the House of Representatives passed important legislation designed to help address this epidemic and to ensure that more innovative treatments are available to patients. The bill, H.R. 6 (the Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment – SUPPORT – for Patients and Communities Act), included several of BIO’s recommendations pertaining to enhancing and improving the ability to utilize expedited approval pathways, which is an important step in getting new innovations to patients.

Specifically, the SUPPORT for Patients and Communities Act would require the Food and Drug Administration (FDA) to hold a public meeting within one year and update or develop new guidance documents covering topics such as:

  • The use of innovative clinical trial designs, real world evidence, and patient experience data for the development of therapies for treating pain and addiction;
  • Eligibility criteria for Sponsors to qualify for expedited approval pathways;
  • Methods for evaluating acute and chronic pain; and
  • Possible endpoints for use in clinical trials for pain and addiction therapies

By clarifying these points and the criteria for expedited approval qualifications, we can encourage greater investment into the development of much-needed novel and safer therapies.

The reality is that it often is not clear to companies who are developing therapies in this area as to whether they qualify for expedited approval pathways or what the FDA’s expectations are for qualifying for such pathways. Additionally, inefficient tools for evaluating pain, like the current “1-10 scale” which does not consider acute versus chronic pain, pain perception, or other comorbidities such as depression and a lack of endnotes makes clinical trials for pain and addiction therapies more difficult.

The legislation, by providing Industry Sponsors and investors a clear path forward through regulatory clarity, would also help support the discovery and utilization of less-addictive medicines – a critical component of a comprehensive plan to solve the opioid crisis.

To date there have been several bills introduced in both Chambers to fight against this growing crisis and we applaud Congress’ hard work in advancing these critical pieces of legislation.

BIO will continue working to promote policies to fight this disease by encouraging the research and development, as well as the timely approval of, and patient access to, novel medicines that improve the way we treat pain and addiction for current and future generations.

For more information about the biopharmaceutical industry’ commitment to combatting the opioid crisis, please visit http://www.bio.org/opioid.