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


FDA Friday: FDA's New Challenge to Help Combat Opioid Use Disorder

FDA Friday: FDA New Challenge to Help Combat Opioid Use Disorder



The Food and Drug Administration has recently launched a challenge to initiate development of medical devices to help combat against the opioid crisis. FDA is looking to medical device manufacturers to help protect and promote the public health by finding new ways prevent and treat opioid use disorder.

Many people are used to hearing “substance abuse” or “substance dependence,” but those terms have become outdated. Current terminology states that “substance use disorders” can be evaluated as mild, moderate or severe. Substance use disorder is defined by the repeated use of drugs and/or alcohol that ultimately results in significant impairment in many areas. The challenge that FDA is promoting focuses entirely on opioid use disorder, a very serious health condition that can have devastating outcomes. Opioids reduce pain perception and are a very effective pharmaceutical solution to certain medical conditions, however, when misused, can cause serious health effects and may lead to addiction. The lurking end to those who tamper with and misuse opioids is, unfortunately, overdose, which has become an increasing occurrence over the past 18 years. It is clear why FDA has focused on this disorder, and expressed a need for medical devices that can help put an end to the countless deaths that come from opioid misuse.

This innovation challenge exemplifies the commitment of FDA to confront medical epidemics, as well as provides developers with the opportunity to work with FDA directly. Some examples of medical devices that are great candidates include diagnostics, devices that prevent diversion of prescribed opioids, withdrawal treatment devices, and pain therapies that exclude opioids. Applications for this challenge will be accepted from June 1 through September 30, 2018. Those who are accepted into the challenge will have direct communication with FDA review divisions throughout the development of the proposed product. Furthermore, the devices that meet the criteria will be granted Breakthrough Device designation. The proposals that are submitted will be evaluated based on the feasibility, public health impact, and novelty of the concept. The number of proposals that will be selected will be based off of the quality of the proposals that are received. The “winning” devices chosen to participate in the challenge will be announced in November 2018. And hey, when industry and FDA come together to battle opioid use disorder, it’s a true win for America!

Prior to the selection of devices and closure of the competition, FDA will host a webinar on July 25, 2018, where developers can ask questions about the challenge. FDA remains committed to addressing the opioid crisis, and this challenge is just one component of their work to reduce the increasing numbers of opioid users around the world.


Further Reading:

  1. Challenge Website

  2. Webinar Website and Information



Medical Device Monday: Gore Cardioform Septal Occluder Supplement

Back in 2006, FDA approved a medical device called the GORE®CARDIOFORM Septal Occluder (Yes, Medical Device Monday typically covers new devices but just bear with us for a second). The GORE®CARDIOFORM Septal Occluder is a heart implant used to close a hole in the heart called patent foramen ovale, or PFO. Recently, the creators of GORE®CARDIOFORM applied to have a supplement to the device approved by the FDA, and we are here this week to tell you that that supplement has been approved. Before we get into what exactly the supplement is, let’s dive a little deeper into what the device does.

First off, there are two different kinds of holes you can have in your heart. One is called an atrial septal defect (ASD), and the other is a patent foramen ovale (PFO). ASD is a congenital heart defect defined by the failure of the septal tissue formation between the right atrium and the left atrium, which are the two upper chambers of the heart. While ASD can occur before birth, PFO can only occur after birth, when the foramen ovale fails to close. This naturally-occurring hole allows blood to circumvent the fetal lungs, which are non-functional until birth. When a baby is born and takes its first breath, the foramen ovale is supposed to close, and within a few months seals completely. However, should it fail to close the the patient is said to have PFO. This occurs in about 25 percent of the normal population with no adverse health effects. In fact, most people with the condition don’t even know they have it! PFO causes small amounts of blood to leak from the right side to the left side of the heart, which can create problems especially if the blood contains a blood clot that could lead to cryptogenic stroke.

To help combat this, the GORE®CARDIOFORM Septal Occluder device consists of an occluder which is implanted in the heart with the help of a delivery catheter (a small tube). The occluder is made of self-expanding Nitinol wire frame, which is covered with a thin ePTFE membrane. The ePTFE is coated with a hydrophilic substance to enable echocardiographic imaging of the occluder and surrounding heart tissue during implantation. The occluder is shaped as two discs connected in the center that makes contact with the walls on both sides of the PFO to stop the leakage of blood between the atria. The occluder can be compacted to a small size to allow it to pass through the delivery catheter to be implanted within the heart. The occluder is delivered at the PFO site using conventional catheter delivery techniques wherein the catheter is inserted through the vein to reach the heart. At the site, the occluder expands where one disc covers the right and the other disc covers the left side of the PFO. Once implanted, the occluder helps block shunting of the blood from the right to the left atrium. The supplement that has been recently approved by FDA was the expansion of the indications to include closure of the patent foramen ovale to reduce another type of stroke, recurrent ischemic stroke. Ischemic strokes occur as a result of a blockage within a blood vessel that supplies blood to the brain, and can lead to extensive brain damage.



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The GORE®CARDIOFORM Septal Occluder is indicated for use in adult patients who have had a previous episode of cryptogenic stroke and are on blood-thinners (such as aspirin) to prevent another stroke. In a multinational clinical study published in the New England Journal of Medicine, there was a 77% reduction in recurrent stroke for cryptogenic stroke patients treated with the GORE CARDIOFORM Septal Occluder plus blood-thinning medication, as compared to blood-thinning medication alone. 

This is a great example of a device that is able to expand its indications after new clinical data surfaces. Congrats to Gore Medical and to those patients who avoid devastating brain damage thanks to this technology!

Click here for a video from the company website explaining the placement of the device.


Suggested Reading:

  1. Approval Letter

  2. Summary of safety and effectiveness

  3. Company website

  4. FDA news release