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  

FDA Friday - Song P. Seto, PhD

This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at

I didn’t have much knowledge about medical device regulation before joining FDA, so I had a lot to learn in the beginning. However, I was very open to learning new things and willing to ask questions. In return, I offered my knowledge and experience to help other reviewers.
— Song P. Seto, PhD

Dr. Seto received her doctorate degree in Bioengineering from the Georgia Institute of Technology, following a Master of Science degree in Education from Pace University and a Bachelor of Science degree in Bioengineering from the University of California, Berkeley. Song’s academic research background in biomechanics and regenerative medicine prepared her well to review complex and varied pre-market submissions, including 510(k), 513(g), De Novo, and Pre-Submission (including pre-IDE) applications. In her role at FDA, Song reviewed the safety and effectiveness of medical devices such as bone void fillers, bone cements, and soft tissue replacement devices for the Restorative and Repair Devices Branch.

Tell us a little bit about your time at FDA.

I joined FDA, specifically the Center for Devices and Radiological Health (CDRH), in 2014, straight out of graduate school. I was a Lead Reviewer for pre-market submissions in the Restorative and Repair Devices Branch of the Division of Orthopedic Devices, which was a good fit given my research background and interests. I reviewed pre-market submissions independently, as well as managed review teams of subject matter experts. One of the nice things about working at the FDA was the opportunity to participate in various activities and training. I participated in Quality Systems training, worked on authoring guidance documents, helped with biocompatibility training, worked on standards, and had the opportunity to plan a FDA-wide Bone Imaging Workshop for over 180 participants.

What was your favorite thing about working with a review team on a premarket notification or approval submission?

There are a many things I really enjoyed. The level and manner of collaboration were great. For example, I worked with subject matter experts that worked really hard to get me the information I needed within some tough deadlines. While working on a submission, everyone was congenial and had the same goal to review a submission with scientific rigor within the regulatory framework.

I also really enjoyed having a variety of experts on the review teams. Subject matter experts often have had past careers, significant research experience, or a long career at FDA that provides important context when reviewing a submission. There were numerous times I pulled a medical doctor or former veterinarian aside to ask about a certain procedure, and I learned so much from their experience in their respective fields. The wealth of experience and knowledge at FDA was truly remarkable and accessible.

You mentioned you worked as a reviewer within the Restorative and Repair Devices Branch. Can you describe the range of devices your group reviewed?

The Restorative and Repair Devices Branch (RRDB) reviews submissions on orthopedic bone void fillers, polymethyl methacrylate (PMMA) cements, scaffolds with bone morphogenetic proteins, intraarticular hyaluronic acid, and many types of soft tissue replacement devices (many in the concept stage). RRDB also sees quite a few combination products for devices that also have biologic and/or drug actions.

What past experience or trait do you think helped you be a successful reviewer?

I didn’t have much knowledge about medical device regulation before joining FDA, so I had a lot to learn in the beginning. However, I was very open to learning new things and willing to ask questions. In return, I offered my knowledge and experience to help other reviewers. It was beneficial to be detail-oriented and organized, as there was a lot of information to digest. Good writing skills were also crucial, because much of the work as a reviewer is preserved through writing, which will help future reviewers understand the decision process. Although my past research experience did not directly impact my work on a regular basis, it did prepare me to quickly analyze data and understand the scientific principles that the medical device technology was based on.

What are you up to these days?

I am currently a Technical Writer for the Florida Space Institute. I know, very different from my regulatory background! Lately, I’ve been reading and writing about in situ resource utilization and how to get humans deeper into space. I also have a side gig as a Scientific Consultant for a firm who performs research as a federal contractor and prepares many Small Business Innovation Research (SBIR) proposals. When I left FDA, I was looking for a more flexible work option, and the opportunity arose to use my skills in a different field. I enjoy writing and supporting researchers, so personally it was not a huge leap. And like my position at the FDA, my current position requires me to be open to learn and to be an effective communicator. I am not totally over with medical device regulation, however. I’ll be looking into getting back into it soon.

What's something that you learned from FDA that helped you in your current position?

How to manage multiple deadlines. Also, to ask questions that seem pertinent to either understanding the proposal or the premise of the proposal that the principal investigator wants to get across.

How is working in industry similar and/or different than working at FDA?

In my current industry, I interface primarily with research scientists and faculty. Let’s just say that most meetings with scientists and faculty (in Florida, to boot) are much more casual than sponsor meetings at FDA. However, preparing research proposals is similar to preparing regulatory submissions in the sense that many times they are sent to a government agency for review. There is still the need to communicate concisely and effectively.

What is some advice you can give to a person interested in regulatory affairs?

I would suggest speaking to a variety of experts in the field; there are many more aspects of regulatory affairs than just getting a product to market.

For anyone interested in working at FDA, I suggest getting in touch with someone in your network that works there. I learned a lot about the culture and responsibilities of being a pre-market reviewer from a former lab mate, and he was instrumental in helping me join FDA.

For those interested in the FDA, I also like suggesting that they read a history of the agency. There are several well-written books out there that highlight the agency’s role in protecting the public’s health. As a reviewer, gaining a better understanding of the FDA’s mission to protect public health and safety allowed me to keep the greater goals of the agency in mind while working closely with industry to bring innovative products to market.

More about Song P. Seto, PhD

For more information about Song, please visit her LinkedIn page. For information about Song and her colleagues’ work at FSI, please click here. To learn more about the Small Business Innovation Research (SBIR) program, please click here.

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