What is an FDA Breakthrough Device Designation?

What is an FDA Breakthrough Device Designation?

The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, is responsible for protecting and promoting public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. As part of its mission, the FDA is also responsible for helping speed innovations to market that make medical products safer, more effective, and more affordable.

To help patients receive more timely access to these innovations without compromising safety, the FDA created the Breakthrough Devices Program. This voluntary program was designed to help expedite the development, assessment, and review of breakthrough technologies, while preserving the regulatory standards for premarket approval (PMA), 510(k) clearance, and De Novo marketing authorization.

Launched in 2018, the Breakthrough Devices Program replaced the Expedited Access Pathway and Priority Review for medical devices. Devices granted designation under the Expedited Access Pathway are now considered by the FDA to be part of the Breakthrough Devices Program.

Providing Timely Access to New Medical Breakthroughs

FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This includes devices subject to premarket approval applications (PMAs), premarket notification (510(k)), or requests for De Novo designation. To be eligible for Breakthrough Device designation, both of the following criteria must be met:

  1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions
  2. The device also meets at least one of the following:
    1. Represents breakthrough technology
    2. No approved or cleared alternatives exist
    3. Offers significant advantages over existing approved or cleared alternatives
    4. Device availability is in the best interest of patients

Benefits of the Breakthrough Devices Program

The Breakthrough Devices Program is comprised of two phases. The first is the Designation Request phase, in which an interested sponsor of a device (usually a company) requests that the FDA grant that device Breakthrough Device designation. The second phase encompasses actions to expedite development of the device and the prioritized review of subsequent regulatory submissions.

The Breakthrough Device designation basically allows companies to benefit from additional FDA input as they work to validate the safety and efficacy of their devices during premarket development, as well as during the submission process, and then expedited review once the submission for the device is filed.

New Medicare Coverage Pathway Finalized for Breakthrough Devices 

For companies with breakthrough-designated devices, recent changes to how the Centers for Medicare & Medicaid Services (CMS) approaches the reimbursement of these devices is another significant benefit. The Medicare Coverage of Innovative Technology (MCIT) (CMS-3372-P) rule finalized January 12, 2021, established a new Medicare coverage pathway that provides Medicare beneficiaries nationwide with covered access to medical devices designated as breakthrough by the FDA. The new MCIT pathway begins national Medicare coverage on the date of FDA market authorization and continues for four years.

Under previous rules, FDA approval of a device was usually followed by a lengthy and costly process to achieve Medicare coverage. The lag time between FDA approval and Medicare coverage has been referred to as the “valley of death” for innovative products. However, under the new MCIT rule, Medicare will provide national coverage simultaneously with FDA approval.

Number of Breakthrough Device Designations in the U.S.

Although the FDA doesn’t make Breakthrough Device designations public (companies can choose to keep their designations private), according to an article published May 27, 2020, nearly 300 Breakthrough Device designations have been granted during the program’s history, including 50 in 2020 as of May 27. In 2019, 136 designations were granted, along with 55 in 2018 , 19 in 2017, and 11 in 2016.

SOLVD Health’s Breakthrough Device Designation for Opioid Use Disorder

SOLVD Health currently holds two of these Breakthrough Device designations. The first was awarded in 2018 for the company’s genetic risk assessment for opioid use disorder (OUD), which is designed to identify patients at increased genetic risk for opioid addiction. The test represents breakthrough technology because it offers higher sensitivity and specificity than other currently used risk assessment tools and is in patients’ best interests because it could help prevent high-risk exposure to oral prescription opioids and subsequent addiction.

Our genetic risk assessment for OUD is currently undergoing expedited review by the FDA. If it receives marketing authorization, it will join a dozen* or so other breakthrough-designated devices that have gone on to achieve final marketing approval.

SOLVD Health’s Breakthrough Device Designation for Detection of Colorectal Cancer and Precancerous Adenomas

The second designation was awarded in 2019 for the company’s test to detect colorectal cancer and precancerous adenomas. The test represents breakthrough technology because it’s the first test to use the gut microbiome to detect precancerous and cancerous lesions in the colon, offers higher specificity and sensitivity for advanced adenomas than other tests currently on the market, and is in the best interest of patients because it could help prevent colorectal cancer through early detection of advanced adenomas.

*as of September 2019

COVID-19 is Worsening the Opioid Epidemic

COVID-19 is Worsening the Opioid Epidemic

As the United States continues to battle the national public health crisis presented by the COVID-19 global pandemic, our nation’s ongoing opioid epidemic is worsening.

To date there have been more than 17 million confirmed cases of COVID-19 in the U.S., and more than 310,000 deaths. In addition to high infection rates and the devastating death toll, the secondary health repercussions of the pandemic have been profound. Increased stress, economic hardship, social isolation, and disruption to healthcare services, among others, have presented significant challenges for many Americans, but perhaps even more so for those battling substance use disorders, including opioid addiction.

Drug Overdoses are Increasing Dramatically

According to the Substance Abuse and Mental Health Services Administration, more than 20 million Americans struggle with a substance use disorder. Based on provisional data from the Centers for Disease Control (CDC), nearly 72,000 Americans died of drug overdoses in 2019, nearing record numbers.

During the first three months of 2020, drug overdose fatalities increased by roughly 10%, according to preliminary numbers from the CDC. If this trend continues, the CDC estimates there will be more than 75,000 drug-related deaths in 2020, which would set a grim record for the second consecutive year.

Compared to the same time periods in 2019, the Overdose Detection Mapping Application Program, a federal initiative that collects data from ambulance teams, hospitals, and police, found that overdose deaths jumped 18% in March, 29% in April, and 42% in May.

When looking at opioid-related deaths specifically, more than 40 states have reported increases in opioid-related fatalities since the COVID-19 pandemic began.

Stress is Taking a Toll on Our Mental Health

According to a CDC survey conducted in June, 13% of U.S. adults said they had started or increased substance use to deal with the stress of COVID-19. In addition, the percentage of Americans reporting symptoms of depression has more than tripled during the coronavirus pandemic.

Due to social distancing guidelines, many Americans are finding themselves increasingly isolated from family, friends, and other support networks, and it is harder for loved ones who don’t live together to physically check in on each other. Because addiction is a disease of uncertainty, isolation, and anxiety, all of these issues can negatively affect people with substance use disorders.

Record-High Unemployment is Creating Economic Distress

In April, the U.S. economy lost 20.5 million jobs, the largest and most sudden decline since the government began tracking the data in 1939, and the unemployment rate soared to 14.7%.

Every 1% hike in the unemployment rate will likely produce a 3.3% increase in drug-overdose deaths and a 0.99% increase in suicides, according to data from the National Bureau of Economic Research and the medical journal The Lancet.

Unemployment, furloughs, salary cuts, loss of health insurance, and other consequences of economic hardship can all contribute to stress, depression, anxiety, and loss of access to healthcare, putting people with substance use disorders at greater risk for relapse and/or overdose.

Access to Treatment & Support Has Been Disrupted

The social isolation imposed by the COVID-19 pandemic hasn’t just interrupted our personal connections with family and friends but has also disrupted access to services for people with mental illness and substance use disorders. These services include doctor’s visits, treatment, counseling, 12-step programs and other addiction support groups, residential programs, and more, leaving huge gaps in the safety net that many people with substance use disorders depend on.

To combat this disruption, many services have transitioned to being delivered online or via telemedicine. In addition, federal and state agencies are realizing the downstream impact of these disruptions in care, and at the federal level, new legislation is being introduced to help people access treatment and recovery programs, including reimbursing telehealth visits and changing in-person prescribing to virtual/remote. However, some services, such as support groups, are hard to replicate on Zoom and also require reliable internet access, which not everyone has. We also don’t yet know how telemedicine may be changing providers’ prescribing patterns.

People with Substance Use Disorders are at Increased Risk for COVID-19

A National Institutes of Health-funded study published September 14 found that people with addiction disorders are at greater risk for COVID-19, and if infected, more likely to be hospitalized or die. This is due, at least in part, to the fact that many substance users have preexisting conditions that would worsen their prognosis. The effect was strongest among those with opioid use disorder, followed by tobacco use disorder, according to the findings.

During the study, the researchers analyzed non-identifiable electronic health records of more than 73 million patients in the U.S. They found that people with addiction disorders accounted for just over 10% of those in the study, but nearly 16% of COVID-19 cases.

In addition, because people with addiction are often already marginalized, it can be even harder for them to access healthcare services when they need them.

Treatment and Prevention are Key to Managing Both Crises

Both COVID-19 and the opioid epidemic are public health problems that require public health solutions. The first part of the solution is making sure we can treat these conditions. For COVID-19, that means having enough hospital beds, ventilators, supplies, and staff to treat sick patients. For opioid use disorder, it’s making sure that people have access to care, treatment programs, medications, and support.

The second part of the solution is prevention. As the COVID-19 pandemic has continued, there have been national discussions around increased testing, increased surveillance, contact tracing, mask mandates, and recently, vaccines have started to become available. For opioid use disorder, the key to prevention is to better understand who is most at risk for opioid addiction and then taking action to prevent it. If personalized risk information is available, affordable, and accessible, then the patient and their provider can make more informed decisions about pain management before that first opioid prescription is ever written.

SOLVD Health is Helping Combat the Opioid Crisis

At SOLVD Health, we’re working to develop and commercialize a potentially groundbreaking genetic test designed to assess a patient’s risk of opioid use disorder prior to receiving oral opioids for short durations, including after procedures such as elective or non-emergent surgeries. Our decision to develop this test was a direct response to the human cost we are seeing in communities across the United States.

Currently, providers often don’t have enough contextual, relevant, and objective information about the patient to identify those at high risk for opioid addiction before it occurs. We believe that unlocking this type of information and identifying individuals who may be at increased risk for opioid use disorder could prevent addiction, save lives, and make a significant impact on curbing the opioid epidemic.

Introducing SOLVD Health, A Patient Intelligence Company

Introducing SOLVD Health, A Patient Intelligence Company

Currently, most of us only interact with the healthcare system after we get sick. Because we often don’t seek care until after we’ve started experiencing symptoms, many health conditions are diagnosed too late and require treatment to manage them. The effects of disease, treatment, and the side effects of treatment not only cause suffering for patients and their families, but also social, emotional, and financial hardship. Yet many of these diseases are completely preventable.

Our Mission

At SOLVD Health (formerly Prescient Medicine), our mission is to solve some of healthcare’s biggest challenges by bringing contextual and actionable health information to everyone, before they get sick. Our work is driven by our belief in creating a world where people don’t have to become patients.

This is a big, bold vision, and we’re ready and eager to rise to the challenge. That’s because we believe the key to our future health lies within us. Modern technology and big data have made it possible to identify early warning signs from our bodies, known as biological signals, that can predict our risk for disease and our future health before we ever get sick. We call this information Patient Intelligence.

Patient Intelligence

In order to prevent disease and realize our health potential, we must first understand the signals of disease. Through the discovery and conversion of biological signals into predictive, actionable, and contextual Patient Intelligence, we are enabling individuals and their healthcare providers to make better decisions about their health and the health of their families.

By combining genetics-based patient insights with cutting-edge technologies like machine learning and custom algorithms, Patient Intelligence has the potential to transform healthcare by:

• Empowering patients and their healthcare providers with objective, actionable information to keep them healthy
• Giving patients insights about their future health risks and helping engage them as a partner in their health management
• Enabling healthcare professionals to make data-driven decisions with more confidence and efficiency
• Enabling healthcare systems to stratify the health risks within their populations at scale, so that they can identify high-risk individuals and deliver the right prevention strategies at the right time

Patient Intelligence changes the relationship we have with our health system from only engaging when we are sick to having an ongoing relationship that is focused on keeping us healthy. Patient Intelligence puts our illness-focused care system on the path to becoming a modernized, true health system. We believe that Patient Intelligence leads us to a future where health is possible for everyone.

Our Core Values

At SOLVD Health, our core values form the heart of our company, guiding everything from our product design philosophy to our regulatory strategy to our customer communications and our hiring practices. These values are what we prioritize day in and day out as we work toward creating a world where people never have to become patients.


We are intentional and purposeful about everything we do.

• We find biological signals that would convert to viable products and bring them to market responsibly.
• We take a data-driven approach and work hard to generate the evidence we need to make sure people are confident when they do business with us.
• Our product design philosophy requires that our products:
– Meet regulatory requirements
– Are useful
– Are safe and effective
– Have economics that work
– Have evidence to back them up
– Are accessible
• We create and sustain a workplace where everyone is aligned with our company mission, goals, and values.


We put people at the heart of everything we do.

• People and their health are our number one priority.
• We don’t just sell tests—we want to improve people’s lives.
• We go above and beyond to understand patients’ and providers’ needs.
• We strive to create products and solutions that patients and their providers can trust to confidently access their health information.
• For healthcare teams, we care deeply about making it easier for them to care for patients. We go beyond just building products—we build tools, education programs, and a community that supports them so they can do what they do best.
• We are authentic, empathetic, and respectful in the way we communicate and treat each other.
• Our employees are valued and feel like active contributors.


We see opportunity in the biggest healthcare challenges.

• We have the courage to solve the biggest unmet needs in healthcare, problems that others have not been brave enough to tackle. We do so by:
– Identifying novel biological signals that can be translated into health products that solve large unmet health problems
– Creating a unique business model that ensures that impactful products can get to the people who need them quickly
– Building a platform that enables continuous discovery of novel biological signals
– Partnering strategically to go beyond providing information, to also provide interventions
• We believe innovation is about taking risks and encourage our employees to think differently and think bigger so we can solve big challenges together.


We empower people to take action through knowledge.

• We believe that knowledge is power.
• Our products are designed to put people and their care teams in control of their future health by giving them the actionable and contextual information they need to make lifestyle and healthcare decisions to prevent disease.
• We empower healthcare providers to make data-driven decisions about treatment plans and interventions so that they can treat their patients with confidence.
• We hire great people and trust them to do their jobs.
• We give our employees the tools, training, and support they need to be successful.


We are determined to bring clarity where there is ambiguity.

• We focus on building products for people and their care teams that:
– Provide clarity about their health risks
– Have clear actions/interventions that they can take to mitigate risk
• Our approach is to be clear and transparent in our communications with our customers, partners, and across the company (vertically and horizontally), always.
• We are clear about our mission and what we need to focus on to get there.

Join Us

We are convinced that predictive, contextual, and actionable health insights can be used to prevent disease and transform healthcare for everyone. Our goal is to accelerate the development of these much-needed health insights, bring them through the regulatory process, and make them available to healthcare providers and their patients. Join us on our journey by signing up for our email list below and following us on Twitter and LinkedIn.