First Electronic Device for Opioid Withdrawal Therapy Approved by FDA

The FDA has given a regulatory green light to the first device that reduces opioid withdrawal symptoms. The NSS-2 Bridge from Innovative Health Solutions, a Versailles, Indiana firm, is stuck to the skin behind the ear and relies on four electrodes that are attached around the ear. The electrodes are used to deliver electric current to a set of occipital and cranial nerves (V, VII, IX, and X), hopefully helping addicts to avoid agitation, insomnia, and other symptoms of kicking opioids. The same device was approved by the FDA three years ago for use in acupuncture and the current approval went under the de novo review process intended for uniquely new low to moderate risk technologies.

The FDA based its decision on a study involving 73 patients that were experiencing physical symptoms of withdrawal. Before using the NSS-2 Bridge, the subjects had an average clinical opiate withdrawal scale (COWS) score of 20.1 (the higher, the worse the symptoms). Using the device, the subjects had a reduction in the COWS score by at least 31% within a half hour of therapy activation. Moreover, 64 out of the 73 patients switched to medication assisted therapy after five days of using the NSS-2 Bridge.

The device requires a prescription and is not intended to be used by patients using pacemakers or that are suffering from hemophilia or psoriasis.

Product page: NSS-2 BRIDGE…

Via: FDA…

Quick and Easy Deuteration and Tritiation of Potential Compounds to Speed Drug Development

During the development of many drugs, radioactive markers and so-called stable labels, typically deuterium and tritium respectively, are often used to trace the destination of  chemical compounds and their metabolites. This is a pretty easy thing to do in lab animals, once you have enough molecules of the compound you’re testing in which typical hydrogen atoms are replaced by their heavier isotopes. Performing this deuteration or tritiation process is currently slow and difficult, taking up to three months to perform on a pretty small amount. Now researchers from Princeton University and Merck, the pharma firm, are reporting in journal Science on a way to compress this process into a day. The development should help to speed the development of new drugs and to get them to market, now a very slow process, a bit faster.

The technique is rather simple, and involves mixing the compound to be tested into a solution of heavy water containing the tritium and deuterium versions of hydrogen. Blue light is shone into this mix, and amazingly the hydrogen atoms swap out, leading some of the hydrogens within the tested compound to be tritium or deuterium.

This was already tested on 18 drugs already used in medicine, as well as candidate drug compounds that Merck is in the process of developing. Because the new technique of deuteration and tritiation is so easy and cheap to perform, drugs in earlier stages of the development process can begin to be tested using injectable labels that would otherwise not qualify due to cost constraints.

Study in Science: Photoredox-catalyzed deuteration and tritiation of pharmaceutical compounds…

Via: Princeton…

SleepScore Labs Releases Its Contact-Free Sleep Monitoring System

SleepScore Labs, a joint venture between ResMed, a medical firm focused on sleep devices, Pegasus Capital Advisors, and Dr. Mehmet Oz, is releasing the SleepScore Max sleep monitoring system. The contact-free device simply rests on the nightstand, watching the patient, and recording sleep events and what stages the person is in at different times of the night. The company claims it has been tested against polysomnography, the typical way sleep studies are done, and performed quite well. We recently spoke with Colin Lawlor, CEO of SleepScore Labs about the company’s technology and what consumers can expect from it.

The nightstand device connects to the user’s smartphone app, which displays every night’s readings, including a “SleepScore,” and provides suggestions on how to improve one’s sleep. In addition to getting readings from the monitoring device, the app also takes data about the person’s activities, such as eating and drinking, which helps to improve the suggestions that it makes.

The device works by sweeping the sleeping person with sound waves 16 times every second looking for even the slightest movement. Software then processes this data and detects breathing and when the person moves around in bed.

Here’s more about the SleepScore Max according to the company’s announcement:

  • SleepScore: A nightly 0–100 score calculating the length and quality of your sleep with SleepScore by ResMed technology, validated with what it believes is the largest comparative PSG dataset of any sleep tracking technology, along with a large number of peer-reviewed scientific publications. A more detailed view is provided in the form of a sleep graph.
  • Sleep Guide: Personalized, science-based advice in the iOS app, triggered by an individual’s sleep data and based on a review of more than 600 clinical papers. Users can also set sleep goals, track weekly progress, and receive comprehensive sleep reports to share with their doctor. The Sleep Guide has been refined over four years, analyzing 2.7 million nights of data.
  • Smart Alarm: Designed to gently wake an individual at the right time in their sleep, so they feel refreshed and ready for the day when they get out of bed.
  • Recommended Solutions: SleepScore Max recommends sleep solutions, such as bedroom lighting, digital sleep therapies, soothing pillows and more, tailored to an individual’s sleep profile and only where the data suggests they may help. Every recommendation has shown to improve sleep and has been evaluated by SleepScore Labs.

Flashbacks: S+, Setting a New Standard in Consumer and Clinical Sleep Technology: Interview with Colin Lawlor, CEO of SleepScore Labs…ResMed S+ Non-Contact Sleep Monitoring System, an Advanced Tracker for Your Zs…

Product page: SleepScore Max…

Via: SleepScore…