Med Device Monday: MolecuLight i:X

FDA recently granted a hand-held imaging device (via the de novo pathway) called MolecuLight i:X. This device allows clinicians to assess, diagnose, and measure wounds by providing real-time imaging of the bacterial distribution with the guidance of fluorescence imaging. Think 'superhero vision'...but for U.S. clinicians! Wound infections are a major cost burden on the health care system and account for increased patient morbidity and prolonged hospital stays. It is estimated that approximately 5.7 million patients in the U.S. are affected with chronic wounds, which comes out to an estimated $20 billion annually.

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So, how does the device work? The MolecuLight i:X emits a specific wavelength of violet light, which interacts with wound tissue and potentially harmful bacteria present in the wound (e.g. porphyrins). The wound tissue and surrounding skin emits a green fluorescence, whereas the bacteria present in the wound emits a red fluorescence. The green and red fluorescence are captured in real-time using specialized optical components, and are then displayed on the device screen.

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The device can detect fluorescent bacteria at levels of  ≥104 colony forming units (CFU)/gram. Clinical studies indicate that MolecuLight i:X can detect common causative organisms associated with wound infections like Staphylococcus aureus/Methicillin-Resistant Staphylococcus aureus (MRSA), Beta-hemolytic Streptococci (Group B), Enterococci, and Pseudomonas aeruginosa. MolecuLight i:X can also detect wound borders and provide wound area measurements. Wound size has traditionally been determined using a wound ruler, which are particularly challenging for irregularly shaped wounds. The device can not only measure wound size and fluorescent bacteria, but it can save those images and track both size and bacteria content over time. This gives clinicians an insight as to how patients are responding to treatment, and whether or not different treatment routes need to be taken.

The device also comes with accessories such as the MolecuLight DarkDrape, which is a high density plastic sheet which can be secured to the patient ensuring appropriate lighting conditions are met when room lights cannot be turned off. Studies showed that MolecuLight i:X-guided treatment significantly increased the rate of wound healing compared with standard of care, and reduced the average closure time of chronic wounds from 200 to 22 days. It's been a while since we've taken a biostatistics class, but that sounds like a pretty favorable recovery time! 

Additional Reading

1.       MolecuLight Website

2.       Letter of Classification

Med Device Monday: Zephyr Endobronchial Valve Approved by FDA

I know, I know, we have gone a little AWOL in the past few weeks. But fear not, we have returned! The exciting news is that AcKnowledge RS is now in a new office space in San Diego.  Come visit us!
Now onto the reason you're here: Medical Device Monday!

Recently, FDA approved a novel device called the Zephyr Endobronchial Valve from Pulmonx Inc. This Zephyr Valve is intended to be used in patients who have difficulty breathing due to emphysema.

It is estimated that about 3.5 million American adults have been diagnosed with emphysema, a chronic obstructive pulmonary disease (COPD) due to damaged alveoli in the lungs. Alveoli are the tiny air sacs of the lungs which allow for rapid gaseous exchange. Unfortunately, the lung damage that results from emphysema and severe emphysema is irreversible. The damaged alveoli can cause the used air to become trapped in the lungs during exhalation. The trapped air may cause diseased parts of the lung to increase in size, which puts pressure on the healthier sections of the lung. This in turn makes it extremely hard to breathe, ultimately resulting in the body being deprived of necessary oxygen.

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Treatment options for people with emphysema are extremely limited, and the treatments options that are available are typically invasive and have high risk. These treatments include lung surgeries like volume reduction or lung transplants. Tina Kiang, Ph. D., from the Division of Anesthesiology in FDA’s Center for Devices and Radiological Health, says that the Zephyr Endobronchial Valve “is a less invasive treatment that expands the options available to patients.” The device was granted Breakthrough Device designation, expediting the agency’s review of the device. Because the Zephyr device offers significant advantages over other existing alternatives, and due to its unique technology, this device earned its breakthrough status.  

Here is how it works:

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The Zephyr Valves are the size of a pencil eraser and are placed into the diseased areas of the lung using a flexible bronchoscope. The valves are intended to prevent air from entering the damaged parts of the lung, and also allow trapped air and fluid to escape. The one-way valves close during inhalation, and open when exhaling, letting out trapped air and relieving pressure.

Data reviewed by FDA included a study that involved 190 severe emphysema patients; 128 of those patients were treated with Zephyr Valves, and the remaining 62 patients were a control group who received medical management only. The results were measured by the number of patients in each group that had at least 15 percent improvement in the area of pulmonary function. In one year of the study, 47.7 percent of the experimental group experienced at least a 15 percent improvement, while only 16.8 percent of patients in the control group experienced the same amount of improvement.

While this device is proving to be extremely helpful for patients with severe emphysema, the Zephyr Valve is contraindicated for patients with active lung infections, active smokers, and those who have allergies to specific metals.  

This is yet another example of how FDA is helping speed innovation by helping get breakthrough devices on the market. Based on our calculations, this file was submitted to FDA on January 2, 2018, and was approved on June 29, 2018.  That means this company got approval in 176 days!  Congratulations to Pulmonx and to the many patients whose lives will be improved thanks to this medical device!


Further Reading:

  1. Pulmonx Website

  2. Clinical Evidence

  3. FDA Press Release




Medical Device Monday: Precision Flow HVNI

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Before we begin, let's take a deep breath! For many Americans, that simple task is not something to take for granted. Fortunately, Vapotherm’s respiratory device, Precision Flow® HVNI, helps neonate/infant, pediatric, and adult patients who are suffering from respiratory distress and/or hypoxemia, to enjoy the simple act of breathing.

Hypoxia is a lack of oxygen in the body— more specifically, a lack of oxygen in the tissue— that is usually brought on by hypoxemia, a low level of oxygen in the blood. Without oxygen, organs like your liver and brain can sustain damage and “suffocate” if oxygenation is not provided in a timely fashion. Hypoxia can be set off by a number of things like asthma attacks, lung diseases, anemia, and heart problems, and if no oxygenation is provided quickly enough, can lead to lung damage. While hypoxia can be lessened with things like inhalers or asthma medications, the Precision Flow is a new oxygenating device that aims to combat these symptoms with some savvy technology. Recently this device was granted a de novo classification by FDA as a High Flow Humidified Oxygen Delivery Device per 21 CFR 868.5454.

The device provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing, and also adds heat and moisture to the breathing gases. The device uses an advanced high flow nasal cannula (HFNC) technique, which is commonly used to provide support for patients with respiratory distress. Interestingly, studies have shown that Precision Flow® HVNI can deliver gas in greater than three times the velocity of conventional humidifiers adapted for HFNC. According to the manufacturer, the HVNI technology functions similarly to the way a water hose would if a thumb was placed over the nozzle; the water (or in this case, gas) exits at a higher velocity. The device has a smaller cannula and a circuit design which helps the breathing gas to flow with higher velocity which, in turn, flushes out the dead space with greater efficiency than conventional humidifiers.

The warm, humidified gas also opens congested airways by helping to clear mucus. Moreover, it provides more comfort to patients when compared to the conventional non-invasive ventilation methods like Continuous Positive Airway Pressure (CPAP) or Nasal Intermittent Positive Pressure Ventilation (NIPPV) because of the small sizing of the cannula. Unlike the CPAP or NIPPV methods which use a mask for respiratory support, Precision Flow® HVNI uses small bore prongs which makes it easier for patients to carry out day-to-day activities like eating, drinking, and talking. In a recent multi-center randomized controlled trial,  treatment with Precision Flow® HVNI was found to be comparable to NIPPV for the treatment of adult patients experiencing undifferentiated respiratory failure in the Emergency Department. The Precision Flow helps clinicians to achieve the goal of delivering maximum respiratory assistance when it's needed the most. That's something we can all breathe a little easier about!


Additional Resources:

  1. How Precision Flow HVNI Works

  2. FDA de Novo Classification Order for Precision Flow

  3. Vapotherm Website  

MDMonday: MiniMed 670G Glucose Monitor and Insulin Pump for Pediatric Populations

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In September of 2017, FDA approved a device for patients with type 1 diabetes aged 14 and up. The device, called the MiniMed 670G, is a hybrid, closed-loop system that provides automated insulin delivery with little to no input from the user. The system includes a glucose-measuring sensor that attaches to the body, an insulin pump that straps to the body, and an infusion patch that connects to the pump with a catheter. This catheter is the way through which the insulin is delivered. Very recently, FDA expanded the approval of this device for use in younger pediatric patients, which now include children aged 7 to 13 with type 1 diabetes.

In patients with diabetes, the body’s ability to make or react to insulin is impaired, and doesn’t function correctly. The pancreas makes little or no insulin in people who have type 1 diabetes. This means that they must keep track of their glucose levels throughout the day, and inject insulin at certain points so they can avoid high glucose levels. FDA Commissioner Scott Gottlieb, M.D. recognizes the struggle for patients with type 1 diabetes, and stated, “Caregivers and families of young patients with diabetes face unique challenges in managing this disease, in particular the round-the-clock glucose monitoring that can be disruptive to people’s lives.” The MiniMed 670G helps to combat hypoglycemic episodes by measuring the glucose levels of the user every five minutes, and automatically adjusting insulin levels by either withholding insulin or administering it. While the device can adjust insulin levels automatically, users must manually request insulin to counter the consumption of carbohydrates at any mealtime.

For this approval, FDA analyzed data from clinical trials of the MiniMed 670G that spanned 105 individuals, aged 7 to 11 years of age. Each participant wore the device for just over three months, and participated in three different phases of the study so both at-home use and remote use could be monitored. At the conclusion of the study, no serious adverse events were found associated with the MiniMed 670G, and it was determined that the device was safe for use in those aged 7 to 13 with type 1 diabetes. FDA Commissioner Scott Gottlieb, M.D. states that, “Advances in science, technology and manufacturing are contributing to the development of new and expanded uses of products that can help improve the quality of life for those with chronic diseases, especially vulnerable populations, like children. Today we’re extending these opportunities to younger children who are especially vulnerable to the impact of this disease, such as the disruptions in sleep that can be caused by the need for frequent blood glucose checks. The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and to ensuring that the path to market is both efficient and effective.”

Getting treatments to pediatric populations has been an ongoing goal for both FDA and industry. Historically, medical device manufacturers and investors have been wary of expanding their products to children as the risk was seen to be too great. Nobody wants to see injured kids due to a medical's bad for business and clearly bad for the children, their families, and their healthcare providers. With this in mind, FDA has implemented policies in the past few years (e.g. sections of the 21st Century Cures Act) that helps industry help children. Getting much needed technology scaled to be appropriate for children is critical to help these populations get the treatment they need! We applaud medical device manufacturers who are (safely) working on treating these vulnerable populations.

Further Reading:

  1. FDA and Pediatrics

  2. 21st Century Cures Act: Sections that Impact FDA

  3. Press Announcement about MiniMed670G Approval

Medical Device Monday: Cala ONE's Essential Tremor Device

What happens when experts in the fields of neuroscience, consumer electronics, and data science come together? While your first thought is likely, "the most epic party ever," the correct answer is: they develop a cutting-edge neuromodulation device. Cala ONE, by Cala Health, is a non-invasive, neuroperipheral therapy device that aims to provide transient relief of hand tremors in adults with essential tremor. The device is another success story out of the de novo program at FDA, and was granted marketing authorization this past April (2018). To understand the impact of the device, let’s talk a little more about essential tremors.

Essential tremor (ET), also once known as familial tremor, is a common movement disorder affecting almost 10 million Americans, and millions more worldwide. The condition is often confused with Parkinson’s, and causes rhythmic trembling of the limbs, head, and voice. The constant shaking makes it difficult to perform even the most basic daily activities like eating, drinking, and writing. Although the exact causes and mechanisms of the disorder are unknown, it is believed that they are mostly inherited, and are caused by tremulous activity within a central tremor neural network.

Current treatment options for tremors centralize almost entirely around medications. Some of these medications include beta-blockers and anti-seizure drugs that often have undesirable side effects. In cases where medications fail, alternative treatments like Botox injections or invasive surgical options are used, which can also be just as dangerous as the side effects that come with medication. Cala ONE promises to be a non-invasive, non-pharmacological targeted nerve stimulator for symptomatic relief of hand tremors. The device, which looks quite similar to a fitness tracker or smart watch, delivers patterned electrical stimulation to the median and radial nerves— part of the peripheral nervous system— in the wrist, through the skin.  Two randomized controlled studies, one being an in-clinic study that included 77 participants, and the other an at-home study that included an additional 61 participants, showed marked improvement in those that received treatment stimulation when compared to those that received sham stimulation. Cala ONE is another device in the ever-expanding area of personalized medicine wherein a physician can measure an individual’s tremor using on-board sensors and tailor the treatment according to the patient.


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This new device aims to benefit people with ET who might not be able to do things that were once second nature to them. Our abilities to hold someone’s hand, throw a dog a ball, enjoy a home-cooked meal, and write our name are often taken for granted. Thanks to neuroscience, consumer electronics, and data science experts coming together (and likely having an epic party of the minds), this device stands to benefit many people who have been unable to take those actions for granted.


Suggested Reading:

  1. FDA de novo Classification Order

  2. Cala Health Website

  3. More information about Essential Tremor