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Articles from 2017 In December

Can Devices Replace Drugs for Migraine Treatment?

eNeura Can Devices Replace Drugs for Migraine Treatment?
eNeura makes teh SpringTMS and sTMS mini devices for migraine treatment. 

Migraine headache sufferers, particularly those who suffer from multiple debilitating episodes per month, can now ask their physicians about versatile non-pharmaceutical, non-invasive treatment devices that can both prevent migraines and lessen the severity of acute attacks.

FDA has granted within the past few months expanded use clearance for two devices that work on the principle of neuromodulation. Interestingly enough, one of the devices, manufactured by Belgium-based Cefaly, had been cleared in 2014 for migraine prevention and was granted expanded approval for acute migraine treatment in November; the other, the SpringTMS device, manufactured by Baltimore-based eNeura, had been approved for acute treatment, also in 2014, and was granted expanded approval for preventive use in September.

Both devices are presently available via prescription only.

The chief executives of both companies believe the time is right to make inroads into a market dominated by pharmaceuticals.

"Drugs work great for some patients, especially for those who don't have very frequent headaches," said David Rosen, CEO of eNeura. "But when you start to move over to the patients who need both an acute treatment and a preventative, the drug treatments begin to fall down for a couple reasons; one, because taking a lot of medications isn't good for you, no matter what. These drugs have some pretty significant side effects, and when you start to mix them, they have even more side effects. No one drug can both prevent and treat migraine, so you end up having to take multiple medications."

Cefaly CEO Pierre Rigaux, MD, said the company is in the “very beginning” of its market push in the United States. It sells about 1,200 units of its device per month nationwide, with a current prescribing base of about 350 neurologists and headache specialists. The company, with a U.S. office in Wilton, CT, has a national sales manager, five regional sales managers, and several independent representatives. Rigaux said Cefaly plans to double its global sales force and grow sales by 50% in 2018.

eNeura's Rosen said he expects neuromodulation will eventually become a well-known treatment modality for migraine, though its time has not quite arrived yet.

"People today, particularly patients, but also doctors to a certain extent, just aren't aware there is an alternative to a triptan or to a preventative like topiramate in order to manage their headaches," he said. "We find when the doctors are informed or the patients are informed and they ask their doctor for the TMS device, the doctors are more than happy to prescribe the device and the patients are really relieved the doctor is willing to prescribe something other than a medication."

Treatment from Front to Back

The devices work to alter neurological signals in different ways on different areas of the brain. The Cefaly device, which can be purchased in single-mode preventive or acute forms or in dual form, is classified as a transcutaneous electrical nerve stimulation (TENS) device. It attaches magnetically to an electrode on the forehead and sends electrical signals along the trigeminal nerve, increasing the number of well-being inducing endorphins and stimulating the touch sensitivity fibers of the nerve at high frequency, partially blocking the entry of pain into the nervous system.

The eNeura sTMS mini device, which resembles a contoured small stereo speaker and weighs slightly more than three pounds, works via magnetic pulse when held to the back of the head. The TMS in the product's name stands for transcranial magnetic stimulation, in which current is passed through specially shaped electrical coils to generate that magnetic pulse.

"When the pulse hits your brain it turns back into current," Rosen said. "The pulse is only powerful for a couple inches. The current resulting can influence how quickly your neurons fire, and can slow down the hyperactive neurons in people with migraines. By slowing them down, we make the migraine go away."

Both devices have recommended duration of time and intensity or number of pulses to either prevent a migraine or combat an existing headache, but Rosen said like any other prescribed treatment, the judgment of physicians and their patients allows for flexibility. He said the fact there are no drug-induced side effects is a plus for neurostimulation.

Neither Rosen nor Rigaux bill their devices as a be-all, end-all treatment, but note numerous trials have attested to the devices' efficacy and say they can work as part of a comprehensive treatment plan agreed upon by a patient and their neurologist or headache specialist.

“Our focus right now is patients who need an alternative or addition to what they are doing with pharamcotherapy,” Rosen said. For example, he noted that migraine sufferers who might be prone to “rebound” headaches due to medication overuse might benefit from adding neuromodulation.

“We ran a small study in the United Kingdom a few years ago to look specifically at rebound headaches to see if they used TMS along with their medications we could demonstrate a reduction in the amount of medication use and in fact we could,” he said. “I think it's a real opportunity for people in desperate need for something to treat their headache and those who know it's probably not a good idea to take more medication—but they have the pain today."

8 Big Medtech Controversies of 2017

<p>AngioDynamics got fed up with competitor C.R. Bard's sales practices this year. In May, the Albany, NY-based company <a href="">sued Bard </a>for allegedly violating federal antitrust laws by tying the sale of its tip confirmation system to its own line of peripherally inserted central catheters (PICCs).</p><p>This puts AngioDynamics at a competitive disadvantage, the company said, because customers who want to buy Bard's tip location system must also buy Bard's PICCs. AngioDynamics sells the BioFlo PICCs. Tip location systems are designed to aid clinicians in the bedside placement of a PICC.</p>

BD Clears Final Regulatory Hurdle for Bard Deal

Pixabay BD Clears Final Regulatory Hurdle for Bard Deal

Becton, Dickinson and Company (BD) said Thursday that its pending acquisition of C.R. Bard has been cleared by the Ministry of Commerce of the People's Republic of China (MOFCOM). Franklin Lakes, NJ-based BD now plans to close the deal Friday, so long as the MOFCOM also approves Merit Medical as the buyer for its soft tissue core needle biopsy product line divestiture.

MOFCOM cleared the Bard acquisition on the condition that BD divests its soft tissue core needle biopsy product line. This was the final regulatory approval needed to complete the Bard deal, said Vincent Forlenza, chairman and CEO of BD. 

BD broke the news in April that it would shell out a whopping $24 billion to acquire Bard. That price represented a 25% premium over Bard's last closing stock price prior to the deal becoming public knowledge. Some BD shareholders seemed to have a case of sticker shock at the time, but the company's management team painted a fairly interesting picture of the long-term value of the combined entity.

In August, Bard delivered on its promise to cast a wider net with the Lutonix 035 drug-coated balloon (DCB) catheter that FDA originally approved in October 2014 for patients with peripheral artery disease. The company told shareholders last year that new indications were in the works and, sure enough, the device received FDA approval this year for end-stage renal disease (ESRD) patients with stenotic lesions in dialysis arteriovenous (AV) fistulae. Previously, the device was limited to the treatment of superficial femoral artery and popliteal artery disease.

Top Medtech News of 2017

<p>For much of the medical device and diagnostics industry, 2017 will be remembered as a year of <a href="">uncertainty</a>, as lawmakers debated <a href="">healthcare reform</a>, President Trump's 2018 proposed <a href="http://">budget cuts</a>, and the fate of the impending <a href="">medical device tax</a>.</p><p>And yet,  as we reviewed the 2017 medtech news based on readership trends, we found that the stories that most grabbed our audience's attention had little to do with what was happening on Capitol Hill, and more to do with regulatory surprises and strategic changes at large companies.</p><p>These were the most popular news stories on MD+DI this year.</p>

Medtech Firms Unite to Give OEMs a Hand Up

Pixabay/JOHNHAIN Medtech Firms Unite to Give OEMs a Hand Up

Five manufacturing services companies that mostly have a presence in Minnesota’s medtech hub have joined forces to help small to mid-size OEMs start getting their products off the ground.

Calling themselves the Medical Device Development Collaborative (MD2C), the group’s members include:

  • Intelligent Product Solutions, a New York-based product design and engineering  company specializing in smart, embedded systems.
  • Borderless Compliance, LLC, an Osseo, MN, regulatory requirements and systems consulting company;
  • South Dakota Partners, an electronics manufacturing, assembly, and distribution company in Clear Lake, SD;
  • Protoduction Inc., a product design and prototyping for electronics, in Edina, MN;
  • Velocity Group, an injection molding and machining company near Cincinnati, OH.

Intelligent Product Solutions, which has engineers in Minneapolis and Seattle, is the face of the six-month-old collaborative by virtue of its design capabilities, which smaller OEMs often seek help with first. But any of the collaborative members can take the lead on a project, depending upon the OEM’s needs and stage of product development.

The owners of the companies had some shared experiences that led them to form MD2C, according to Andrew Stelmack of the Velocity Group. The shift toward data and analytics in medical devices had led several of their customers to outsource of product design and development. Clients were also frequently asking for referrals to firms that can help them with the next steps. The would-be collaborative realized that having this network in place could help OEMs eliminate the costly and time-consuming search for the next right partner.

“A lot of companies that are out there are really just are missing a broad swath of internal capabilities,” Stelmack told MD+DI. “We realize there’s value in not just a referral and a handoff but having a group of companies that we work with on a regular basis, and we become one integrated capability.”

The Medical Alley Association, Minnesota’s medtech trade group, was instrumental in bringing the coalition partners together, Stelmack added.  While it’s not the first collaborative of its kind in medtech, MD2C is informal in that it does not require OEMs to fit into a particular model to become clients.

The group recognized that product design and final assembly are what most OEMs want “right next door,” while having parts fabrication in another state was less important, Stelmack added.

“The whole point was to try to pull together the complete end-to-end set of services. That’s the part that a lot of OEMs prefer, so they're not having to build those capabilities but also not having to spend a lot of time managing all these vendors,” he said. “Once we recognize their needs and program requirements, then we’ll put together the right parts of the team to work with the company. We keep it lean and keep it focused on the value that the customer actually needs.”

Supplier Stories for the Week of December 17

This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to with the subject line “Supplier Stories.”[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Must-Know FDA Guidance Documents from 2017

Maklay62/ Must-Know FDA Guidance Documents from 2017

In 2017, FDA issued several new and updated guidance documents, furthering the agency’s mission to advance public health by helping to speed innovation, and bring more effective and safe medical devices to the marketplace. Here are the documents that are important for medical device manufacturers and industry to know.

Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff

What FDA says: This revised guidance provides an overview on how manufacturers should engage with FDA regarding requests for agency feedback on issues relating to potential premarket applications and submissions. The document characterizes the feedback mechanisms and outlines information on the logistics for submission, receipt, tracking, and response to these requests.

Benefit: This guidance is a useful tool for obtaining FDA input on multiple pre-submission topics, including the regulatory path to market, the design of nonclinical, analytical and clinical testing, and submission review issues. The document addresses challenges that were not outlined in the previous version of the guidance, including an explanation of the agency’s expectations during the pre-submission process.

Challenge: Companies must keep current on FDA procedural changes and relate the new guidance to existing procedures. Properly timing pre-submission interactions and providing the necessary documentation to obtain needed input in the appropriate timeframe could also prove challenging.

Path Forward: Device makers should become familiar with the pre-submission program and learn to utilize these pre-submission engagements to streamline the premarket application/submission process. It can be beneficial to work with a partner who understands current FDA pre-submission program guidelines and the U.S. regulatory landscape.

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

What FDA says: This document defines interoperable devices and highlights design considerations in the development of electronic devices for manufacturers to prove reasonable assurance of a device’s ability to safely and effectively exchange and use exchanged information. It also outlines labeling considerations and explains the need to perform risk analysis, since creating connected systems of medical devices may introduce unforeseen safety and effectiveness issues.

Benefit: Creating systems of interoperable medical devices can improve efficiency and reduce cost. The recommendations outlined in this guidance regarding what information should be included in premarket submissions and device labeling provide insight into what the agency is expected to emphasize in its review of inoperable medical devices.

Challenge: Only recommendations for inoperable devices are addressed in this guidance, and no requirements are established. Additionally, the guidance does not focus on the physical compatibility of a device, or when a specific inoperable device or device modification would require a premarket submission.

Path Forward: Manufacturers should consider these recommendations throughout design, development, and submission preparation of inoperable devices.

Breakthrough Devices Program: Draft Guidance for Industry and FDA Staff

What FDA says: This guidance defines a breakthrough device and outlines how manufacturers can work with FDA on managing submissions for medical devices identified as such. This new voluntary program supersedes the agency’s existing programs, including the Expedited Access Pathway (EAP) and the Priority Review Program, while combining some aspects of the EAP and Innovation Pathway.

Benefit: This program will allow breakthrough devices priority attention, thereby expediting their assessment and review over other devices. The priority attention given to breakthrough devices will help patients have more timely access to these products.

Challenge: While breakthrough devices are granted priority review, they are not guaranteed a faster review when compared with standard review timelines. Breakthrough devices may take longer to review due to the potential scientific challenges FDA has historically encountered with novel products. Reviewers may have to invest time in understanding the mechanism of action and the appropriate evidence to demonstrate safety and effectiveness.

Path Forward: Manufacturers should review the breakthrough device designation criteria carefully to learn whether they may qualify for participation in the program. Designation is ultimately decided by the agency through the pre-submission process.

Classification of Products as Drugs and Devices and Additional Product Classification Issues (Final Guidance)

What FDA says: The guidance addresses issues pertaining to whether a product should be classified as a drug, device, biological product, or combination product. The document has two main sections: one outlines the request for designation process for obtaining a formal determination of a product’s classification and the other presents concepts for FDA’s decision-making process for classification.

Benefit: The guidance provides clarity on the process for product classification, which will enable informed planning for product development.

Challenge: While the guidance provides clarity for the process, determining the appropriate classification for a new product can be difficult.

Path Forward: Device companies should review the guidance in depth to become familiar with the process for classification and FDA definitions. Engaging a partner with experience in applying FDA’s classification process may make sense for situations in which the classification is not clear.

How to Prepare a Pre-Request for Designation (Draft Guidance)

What FDA says: This draft guidance describes how to obtain a preliminary assessment from FDA through the pre-request for designation (Pre-RFD) process. This process provides informal, non-binding feedback on the regulatory identity or classification of a human medical product as a drug, device, biological product, or combination product.

Benefit: FDA is enhancing the transparency and consistency of the process for receiving preliminary feedback on how a product will be regulated.

Challenge: While sponsors can request meetings with the agency either before or after submitting their Pre-RFD, the review time for their Pre-RFD may be extended. If a product is significantly changed during the Pre-RFD process, the feedback given by the agency may no longer be applicable and the need to submit a new pre-RFD should be assessed.

Path Forward: Manufacturers wishing to obtain a preliminary assessment from the agency should consider the recommendations outlined in the guidance.

Current Good Manufacturing Practice Requirements for Combination Products

What FDA says: The guidance defines a combination product and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products. The document clarifies the application of existing CGMP requirements and outlines how manufacturers can manage and report post-market safety data.

Benefit: Prior to this final rule, there were no regulations to define the application of CGMP requirements to combination products. These regulations establish a transparent and streamlined regulatory framework for manufacturers to use when demonstrating compliance with applicable CGMP requirements.

Challenge: The rules under this guidance still require interpretation.

Path Forward: FDA will expect that manufacturers comply with the regulation.

Qualification of Medical Device Development Tools

What FDA says: This guidance describes a voluntary program for qualifying medical device development tools (MDDT) used to evaluate the effectiveness, safety, or performance of a medical device and to support regulatory decision-making. The document defines the three categories of MDDT: clinical outcomes assessment, biomarker test, and non-clinical assessment model.

Benefit: This policy will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision-making.

Challenge: The final guidance does not mention the review of tools submitted in individual premarket submissions for use with a specific medical device, nor does it address the expectations for the qualification of an individual MDDT submission.

Path Forward: Manufacturers should consider whether the tool(s) they are using for evaluating their medical device could be candidates for this program. The qualification process for the voluntary MDDT program should be carefully reviewed.

Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

What FDA says: This document specifies expectations for reporting age, race, and ethnicity data for medical device clinical studies. It outlines recommendations for achieving enrollment and subgroup analyses.

Benefit: The document improves the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and ethnic groups.

Challenge: Obtaining the appropriate enrollment of diverse populations could prove difficult.

Path Forward: To achieve an unbiased estimate of treatment effect in the general population, manufacturers will need to develop a strategy to enroll diverse populations that is consistent with the intended use population of the device.

4 Things Medtech Should Be Prepared for in 2018

4 Things Medtech Should Be Prepared for in 2018

Medical device and diagnostics companies making a list of new year resolutions might want to take note of a new trends report published by consulting firm North Highland.

According to the North Highland Beacon 2018: Healthcare and Life Sciences report, cybersecurity and compliance are still top concerns across the healthcare and life sciences sectors, but 86% of leaders surveyed by the firm indicated that transformation and adaptability are the keys to competitiveness. 

1. Cybersecurity

Cybersecurity was the top strategic priority for the healthcare industry, yet only 25% of survey respondents said they felt very prepared to address it. The report authors speculated that the low levels of confidence in addressing cybersecurity likely stem from nuances regarding personal health information and Internet-enabled medical devices. While cybersecurity must be an actively-managed risk, the authors said it need not be the primary business strategy.

2. Transformation

Transforming to be more efficient was cited as a definite competitive advantage by 62% of respondents, and 41% said it was much more important for 2018, but only 31% said they are very prepared to address it.

"While less than a third of healthcare leaders feel prepared to address this challenge, every healthcare company in the world could transform for efficiency," the authors noted. "One of the challenges for this complex sector is that it has not historically been proactive in this realm. A holistic strategy where centers of innovation are communicating effectively would engender a more cohesive execution of transformation."

3. Innovation, IoT, and AI

The survey found that healthcare leaders feel ready to tackle areas that could lead to competitive advantages, such as product enhancement innovation, Internet of Things, and artificial intelligence. Despite this readiness, however, respondents indicated that they are focused on other priorities for 2018.

"While leaders may be focused elsewhere, there is an urgency for healthcare companies to use these tools to communicate and engage with customers," the North Highland experts noted. "Healthcare is cumbersome whether consumers are purchasing medicine or medical devices, scheduling appointments, or seeking care or advice."

The report's authors point out that today’s consumers are accustomed to fast and easy mobile shopping and banking served up with proactive customer engagement. "Unless healthcare becomes more hassle-free, people will look for the path of least resistance in how, when, and what they choose for care," they said.

4. Adaptability

Adapting to changing customer needs and customer centricity was another priority the report uncovered, yet only 21% of those surveyed said they feel very prepared for customer centricity. Respondents called out lack of knowledge or skills, and budget pressures as barriers to adaptability.

"Lack of knowledge and skills is a massive challenge in healthcare. One such challenge is a lack of broad or disruptive thinking," the authors said. "If healthcare leaders consider applying solutions that have made a disruptive impact in other industries, they will find the competitive advantage they are seeking."

The report suggests that healthcare can close the gap on shrinking growth by getting more in tune with what modern-day patients and caregivers need and want.

Will Trump Listen to AdvaMed's 11th Hour Tax Plea?

Pixabay Will Trump Listen to AdvaMed&#039;s 11th Hour Tax Plea?

AdvaMed is making a last-ditch effort this week to stop Uncle Sam from pulling the trigger on the impending medical device excise tax in January.

Scott Whitaker, the organization's president and CEO, penned a letter to President Donald Trump on Wednesday explaining why the medical technology industry cannot afford to wait for Congress to take action on the device tax issue.

"I understand that there have been discussions about addressing the device tax and other policies early next year," Whitaker noted in the letter. "The concern we have in applying retroactive relief to the device tax is a function of the unique status of this specific excise tax, compared to other business taxes that are generally paid at the end of the year."

If the device tax goes into effect in 2018, companies are expected to begin making payments in January on a bi-weekly basis, Whitaker explained. He said companies will spend millions in compliance costs to ensure processes and reporting are up and running to be ready to submit money to the IRS and avoid compliance penalties.

"Many companies have delayed these efforts in anticipation of repeal or further suspension of the tax, and will be incurring new costs that are not recoverable in a retroactive fix," Whitaker said.

The letter also pointed out that waiting until next year to repeal or suspend the device tax, if that were to happen, would create a hassle for the IRS, because the agency would have to go through the process of refunding payments to companies, a process made more difficult by the fact that the money is deposited in the general Treasury accounts and is based on individual sales, Whitaker noted.

"If companies make payments and the tax is retroactively repealed/suspended, then it is likely the IRS will have to issue guidance and set up an administrative process to issue numerous refund claims from companies," he said. "The entire process could take months before all payments are returned to companies."

Whitaker asked Trump to work with Congress to prevent the 2.3% levy from being reinstated on the medical technology industry, as any potential retroactive action next year would not fully undo the impact of triggering the tax on Jan. 1.

"Short of legislative action, I would strongly encourage you to direct the Treasury and IRS to provide whatever administrative relief you can," Whitaker told Trump.

The letter also refers to a Nov. 10 letter from AdvaMed to the IRS in which the organization describes the steps that can be taken to waive the bi-weekly deposit requirements.

Whitaker's letter comes a week after the U.S. House of Representatives proposed a five-year extension to the current medical device suspension.

The tax, which was built into the Affordable Care Act, first took effect in 2013. Congress passed a two-year suspension of the tax in 2016. The hope, at least at the time, was that the two-year respite from the tax would give advocates enough time to persuade lawmakers to get rid of the tax for good.

5 Self-Care Trends According to Amazon Best-Seller and Wish Lists

5 Self-Care Trends According to Amazon Best-Seller and Wish Lists
Image source arka38/Shutterstock

To find out some of the latest trends in self care, we thought we’d check the world’s biggest marketplace, Amazon, for the best-selling and the most-wished-for medical supplies and equipment.

Judging from the following rankings at Amazon, the biggest self-care trends are genetic testing, elimination assistance, fitness tracking, pain relief, and alcohol and marijuana use testing.

On December 20, the top-10 best-selling medical supplies and equipment on Amazon were:

  • 1. AncestryDNA Genetic Testing DNA Ancestry Kit
  • 2. 23andMe DNA Test Ancestry Personal Genetic Service
  • 3. Squatty Potty The Original Bathroom Toilet Stool, White, 7 in.
  • 4. Fitbit Charge 2 Heart Rate + Fitness Wrist Band, Black, Large (US Version)
  • 5. Squatty Potty The Original Bathroom Toilet Stool, White, 9 in.
  • 6. 23andMe DNA Test- Health + Ancestry Personal Genetic Service
  • 7. Fitbit Charge 2 Heart Rate + Fitness Wrist Band, Black, Small (US Version)
  • 8. HealthmateForever YK15AB TENS unit Electronic Pulse Massager
  • 9. Fitbit Alta HR, Black, Small (US Version)
  • 10. Etekcity Digital Body Weight Bathroom Scale With Body Tape Measure, Tempered Glass

And on December 20, the top-10 most-wished-for medical supplies and equipment were:

  • 1. AncestryDNA Genetic Testing DNA Ancestry Kit
  • 2. AccuMed THC10-PP Marijuana (THC) Single Panel Dip Card Drug Test (Pack of 10)
  • 3. 23andMe DNA Test Ancestry Personal Genetic Service
  • 4. Fitbit Charge 2 Heart Rate + Fitness Wrist Band, Black, Large (US Version)
  • 5. The Health Gurus Fingertip Portable Pulse Oximeter
  • 6. AccuMed 25-count pregnancy (HCG) Test
  • 7. AccuMed Professional Blood Alcohol Breath Tester Breathalyzer x/LED Display
  • 8. 23andMe DNA Test- Health + Ancestry Personal Genetic Service
  • 9. Squatty Potty The Original Bathroom Toilet Stool, White, 7 in.
  • 10. AccuMed AP212 Portable TENS Unit Electronic Pulse Massager with 16 Modes

From these lists, we can safely say that shoppers are pretty interested in the following: 

Genetic Testing

It shouldn’t be too surprising that genetic-testing kits lead both lists. Last year 23andMe was one of MD+DI’s Company of the Year finalists after the company rebounded from an FDA warning letter. The company was later able to reintroduce consumer genetic tests related to health. Also popular for unlocking ancestry details is AncestryDNA. Consumers may see a bit of a price dropping

Elimination Assistance 

Everyone eliminates, and some may need a little help. Squatty Potty reports on its Web site that "studies show the natural squat position improves our ability to eliminate. Squatty Potty toilet stools help you simulate a squat position for a faster and more effective elimination." The Amazon lists above show the stool for your stool is pretty popular this holiday season. It is racking up strong sales and has expanded into several models and styles.

Fitness Tracking

Fitness-tracking devices continue to perform well, despite some hurdles. Fitbit is forging ahead with its new Fitbit Charge 2, which offers the PurePulse Heart Rate feature, multiple-sport tracking, and other elements. The future looks even brighter now that FDA is working closely with Fitbit and other tech companies in the Software Precertification (PreCert) Pilot Program under the agency’s Digital Health Innovation Program, MD+DI reported.

Pain Relief

These days patients and healthcare providers are on the lookout for non-drug approaches to pain relief, so we’d expect to see products like HealthmateForever YK15AB TENS unit Electronic Pulse Massager and the AccuMed AP212 Portable TENS Unit Electronic Pulse Massager on these lists. For instance, the Healthmate unit provides transcutaneous electrical nerve stimulation and powered muscle stimulation with eight different massage modes. Of the more than 6000 customer reviews on Amazon, 70% were five-star reviews.

Alcohol and Marijuana Use Testing

Finally, with legalization of recreational marijuana use expanding, determining the level of impairment is on the minds of users and law enforcement. And with the holidays, alcohol use could present some concern. AccuMed’s Professional Blood Alcohol Breath Tester Breathalyzer x/LED Display and THC10-PP Marijuana (THC) Single Panel Dip Card Drug Test (Pack of 10) are popular items on shoppers’ wish lists. Interestingly, according to Amazon, these two products are “frequently bought together.”

Keep in mind that as shoppers continue to shop these lists constantly change. The above lists are just a snapshot taken on December 20, so be sure to click on the links to get up-to-the-minute rankings.