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SUNNYVALE, Calif., March 1, 2024 – iHealth Labs, Inc. (iHealth®), a leading provider of digital health solutions, announced today that it has been named the 2024 Tech Innovation Company of the Year by the Sunnyvale Chamber of Commerce. The Celebrate Sunnyvale Awards, previously named The Murphy Awards after City of Sunnyvale founder Martin Murphy Jr., recognizes the contributions of local businesses, individuals, and organizations to the Sunnyvale community.
As the honoree in the “Outstanding Innovation and Technology” category, iHealth was recognized for its consumer-friendly mobile personal healthcare products, its Unified Care program – which provides access to iHealth’s smart medical devices for remote patient monitoring and management of chronic conditions – and for its role in making its orange-box COVID-19 tests widely available during the pandemic. To date, the company has supplied over 1 billion test kits and donated $10 million of tests and PPE to local governments and community organizations.
"During the pandemic, businesses, nonprofits, and residents of Sunnyvale relied heavily on iHealth Labs’ COVID tests to keep employees and families safe and protect the health of the community," shared Sunnyvale Chamber of Commerce Board Member Marie Bernard. "The Chamber of Commerce's recognition of iHealth Labs as Sunnyvale’s Technology and Innovation Company of the Year is a testament to the company’s commitment to enabling people to lead healthier lives. iHealth’s cloud-connected healthcare solutions set the standard for innovation and progress, and are making quality health management more accessible. It is truly our honor to recognize iHealth’s many achievements and we congratulate the team at iHealth on this prestigious award.”
“We are thrilled and humbled to be the recipient of this distinguished award that carries such a history of accomplishment by organizations in the innovation and technology category,” noted Jack Feng, CEO of iHealth. “We are proud to be honored alongside our fellow Sunnyvale businesses.”
The 2024 Celebrate Sunnyvale Awards & Gala was held last night at the Hilton Garden Inn, with Sunnyvale city officials and dignitaries in attendance. Notable previous honorees in the “Outstanding Innovation and Technology” category over the years include Google and Comcast.
About iHealth Labs, Inc.
iHealth®, a leading provider of digital health solutions, offers a range of IoT medical devices: blood pressure monitors, glucometers, thermometers, oximeters, and at-home test kits (including its widely-recognized orange-box COVID-19 tests). Since its founding in 2010, the company’s consumer-friendly healthcare solutions have been making quality health management more accessible and affordable.
In 2018, the company introduced iHealth Unified Care, a full-service program for remote patient monitoring (RPM) and chronic condition management (CCM) that enables doctors and patients to manage conditions such as diabetes and hypertension more effectively. By combining innovative technology with expert personnel, patient education about diet and lifestyle, and wrap-around support, iHealth Unified Care is bridging the gap between clinic and home to significantly improve patient outcomes.
iHealth is actively partnering with medical clinics in Sacramento and the San Francisco Bay Area to empower healthier lives by simplifying the management of chronic conditions.
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Sunnyvale, CA, October 10, 2023 – iHealth Labs, Inc. (iHealth), a leader in innovative, consumer-friendly, mobile personal healthcare products, today announced savings up to as high as 63% off for the upcoming Amazon October Prime Big Deals Days October 10 & 11. iHealth’s Big Deal products include its #1 best-selling no-touch thermometer and highly-rated at-home Covid antigen rapid test.
As a featured brand partner of Amazon Buy with Prime in the Wellness category, iHealth also offers Prime shipping on its DTC (direct to consumer site), on a curated collection of products.
On the heels of Amazon’s July’s Prime days, the October iteration of the popular and highly anticipated savings event gives Prime members an opportunity to get a head start on buying gifts before Black Friday and Cyber Monday with the holiday season just around the corner as well as to stock up on essential products.
iHealth’s Amazon October Prime Big Deal Days offers are:
Prime Big Deal Days: $29.60 (MSRP $79.99) 63% off
This sleek smart digital scale currently enjoys a 4.6 rating on Amazon and features 12 Essential Body Composition Analysis.
Prime Big Deal Days: $26.97 (MSRP $44.95) 40% off
As the country’s preferred Covid test and named “Best Overall At-Home COVID- 19 Test” by Health.com, iHealth’s COVID-19 Antigen Rapid Test is the simplest way to detect SARS-CoV-2 nucleocapsid protein antigen and its variants.
Named among the “Best Thermometers of 2023” by Verywell Health, iHealth’s PT3 is one of the top-selling thermometers in the US and the #1 best-selling baby thermometer on Amazon.
Prime Big Deal Days: $27.99 (MSRP $49.99) 44% off
The Track Wireless Blood Pressure Monitor was named as one of “3 Best Blood Pressure Monitors” by Good Housekeeping and cardiologists.
Prime Big Deal Days: $33.59 (MSRP $59.99) 44% off
The iHealth AIR fingertip pulse oximeter can accurately detect SpO2 (blood oxygen saturation) level, pulse rate, and pulse strength in seconds.
Prime Big Deal Days: $20.00 (MSRP $49.99) 60% off
This lightweight, compact wrist blood pressure monitor enables seamless blood pressure tracking whether traveling, at the office, or on the go.
“We are thrilled to offer the best possible price points and significant savings on critical healthcare items during the October Prime Big Deal days that enable people of all ages to take a proactive role in maintaining their health and well-being,” stated iHealth Labs CEO Jack Feng.
About iHealth Labs, Inc.
iHealth is dedicated to empowering people to live healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud that allows consumers to easily measure, track, and share vital health information with their doctors. With a focus on delivering high-quality and accessible products, iHealth is at the forefront of the digital health revolution.
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Sacramento, CA, September 28, 2023 – iHealth Labs, Inc. (iHealth), a leader in digital health innovation and one of the major providers of at-home COVID tests in the U.S., continues its commitment to advancing healthcare solutions with its announcement today of the establishment of a new office in Sacramento at 8950 Cal Center Drive to accommodate its rapidly growing Unified Care program.
With its contributions as a pivotal COVID-19 home test provider and a decade-long dedication to reimagining chronic disease care, iHealth Labs is poised to amplify its impact for population health with the expansion of the Unified Care program in Northern California, especially the Greater Sacramento Area. The region has witnessed a remarkable transformation in its senior population, with a growth rate exceeding 50% from 2010 to 2020, according to recent census reports. An aging population often brings a higher prevalence of chronic health conditions, leading to increased demands on physician visits, hospitalizations and long-term care services.
The Unified Care solution is designed to close the gap between physician visits and patient’s home monitoring and self management. In this model, iHealth builds an ancillary care team to provide holistic in-person and remote care for chronic disease management and support patients between office visits. This enables physicians to better manage their patient population.
The transformative approach integrates the care team with physicians to provide remote vitals monitoring, personalized nutrition counseling, health behavior coaching and seamless care coordination, all backed by data-driven software and smart devices.
Since 2018, a total of 40 primary care practices in the Sacramento area have embraced iHealth Unified Care and achieved remarkable milestones, including a 25% improvement in blood pressure and diabetes control rates. iHealth also launched strategic partnerships with local independent physician groups, including Sutter Independent Physicians, to focus on care quality improvement for population health.
And a recent retrospective analysis of over one-third of the patients under the Unified Care model demonstrated significant enhancements in HbA1c and blood pressure levels [1,2].
The achievements have translated into superior clinical outcomes, heightened physician engagement and elevated patient satisfaction. The program enjoys a 95% patient satisfaction rate, with 10,000+ total patients currently enrolled, of which 62% are Medicare beneficiaries.
“The Sacramento office opening marks our commitment to redefine healthcare solutions, foster healthier lives and communities. By uniting its prowess in COVID-19 testing with its groundbreaking Unified Care model, iHealth Labs is poised to lead the way in shaping a brighter future for healthcare delivery,” stated Jack Feng, iHealth Labs CEO.
Additionally in July, iHealth relocated its headquarters office in San Jose to a larger office at 880 West Maude Avenue in Sunnyvale, also to accommodate the Unified Care expansion.
“This is an exciting time for iHealth. Not only are we celebrating the company’s 13th anniversary in 2023 and continuing to build our Unified Care team with two office expansions, on the ecommerce side, we’ve also enjoyed steady growth as we launch new products in the digital health category,” noted Feng.
About iHealth Labs, Inc.
Founded in 2010, iHealth is dedicated to empowering people to live healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud that allows consumers to easily measure, track, and share vital health information with their doctors. With a focus on delivering high-quality and accessible products, iHealth is at the forefront of the digital health revolution.
In 2018, iHealth established the Unified Care program to address the issue of managing chronic diseases. iHealth Care specialists support patients beyond the doctor’s office with chronic conditions via Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) to achieve better health outcomes.
In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter sales. Since then, iHealth has emerged as a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. With its commitment to helping people lead healthier lives, iHealth is poised to continue driving positive change in the healthcare industry.
Visit www.ihealthlabs.com to learn more.
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Irwindale, CA, August 16, 2023 – iHealth Labs, Inc. (iHealth), a leading provider of at-home COVID tests in the U.S., announced today its manufacturing facility for COVID-19 tests in Irwindale, CA has manufactured over 70 million test kits. The dedicated team at iHealth has made a substantial investment to establish this US-based production facility for COVID-19 at-home test kits to fulfill the requirements of its contract from the Federal Government.
“We are extremely proud to be selected by iHealth as the location for the first fully automated facility dedicated to the production of COVID-19 test kits in the US,” stated Mayor H. Manuel Ortiz of the City of Irwindale. “The iHealth team recognized Irwindale’s unique business environment that combines a focus on economic development and building a small-town community.”
The over 70 million COVID Antigen tests is equivalent to over 170 truckloads of cargo. As the COVID virus continues to evolve, including the recent discovery of the EG-5 variant, iHealth stays vigilant and adaptable by monitoring updates and trends.
Most recently, COVID hospitalizations in July in the US saw its biggest spike since December 2022. For a recent week at the end of July, COVID-19 hospital admissions were up by 12 percent from the week before and emergency department visits up by 17 percent, according to CDC data cited in a PBS news story.
iHealth saw a sales increase of nearly 80% of its Covid antigen rapid test in the second week of August over the first week, an indication of the public awareness of the uptick in cases and urgency in regular testing. iHealth’s Covid test was recently selected by Health.com as “Best Overall” at-home Covid test.
“With the recent rise in COVID cases, iHealth has ramped up production of our antigen rapid tests. We are committed and ready with our manufacturing capacity to support the increased need around the country for testing,” noted iHealth CEO Jack Feng.
iHealth opened its first US-based manufacturing facility in Irwindale in August 2022 to support and advance economic prosperity in the local community. The new facility spans 57,800 square feet and boasts 32 production lines. iHealth has created hundreds of local jobs and has production capacity of up to one million tests per day.
"This new factory's fulfillment of the federal government contract marks a new era of growth for iHealth," said Jack Feng. "Securing this contract was a significant milestone for us in expanding our physical capacity and regional network to support further growth and development. Our investment in the new manufacturing facility aligns with our long-term strategy since it is equipped to produce other in vitro diagnostic medical devices, enabling the company to respond swiftly to changing requirements."
About iHealth Labs, Inc.
iHealth is dedicated to empowering people to live healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products through the cloud that allows consumers to easily measure, track, and share vital health information with their doctors. With a focus on delivering high-quality and accessible products, iHealth is at the forefront of the digital health revolution.
In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter sales. Since then, iHealth has emerged as a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. With its commitment to helping people lead healthier lives, iHealth is poised to continue driving positive change in the healthcare industry.
About iHealth Manufacturing Inc.
iHealth Manufacturing Inc was established in August 2022 in Irwindale, California, and features state-of-the-art production equipment. The facility is currently focused on producing the COVID-19Antigen Rapid Test and will be manufacturing flu test kits in the future. With the ability to update its production lines to make a variety of test kits, iHealth Manufacturing Inc. can quickly meet the future testing needs of U.S. consumers.
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Sunnyvale, CA, August 1, 2023 – iHealth Labs, Inc. (iHealth), a digital health company and leading provider of at-home COVID tests in the U.S., announced today the release of its Home Collection Kit for HIV and syphilis testing. The FDA-approved solution enables anyone over the age of 18 to collect a blood sample to test for HIV (I, II, P24 antigen) and syphilis in the privacy of their own home, mail it to the lab with prepaid overnight label and receive reliable and confidential results in as soon as two days.
iHealth launched the home collection solution, its first in the STD OTC test category, in response to the growing STD crisis in the US. To reverse this trend, the Centers for Centers for Disease Control and Prevention (CDC) has called for more groups from local, healthcare industry and public health sectors to contribute to STI prevention and innovation effort.
“With our entry into the STD at-home testing market, we are heeding this challenge from the CDC for organizations to step up to the plate and contribute in alleviating a growing health crisis,” noted Jack Feng, CEO of iHealth Labs.
A Critical Need for STD Testing
According to the CDC, over 2.5 million combined STD cases are reported across the U.S. in 2021. These statistics do not include those who have STDs but may not know it, don’t get tested, etc. Although most STIs and STDs can be treated with antibiotics or antiviral drugs, many people have no noticeable symptoms.
HIV: An estimated 1.2 million people in the United States had HIV at the end of 2021, with 1 in 8 not knowing that they had it. Multiple studies have demonstrated the value of at-home testing for increasing the frequency of HIV testing, identifying new diagnoses and reaching people who reported they have never previously tested for HIV.
Syphilis: According to the CDC’s Sexually Transmitted Disease Surveillance for 2021, reported cases of syphilis (all stages) have increased by a staggering 74 percent from 2017 to 2021. Rates increased among both males and females, in all regions of the United States and in all age groups.
Advantages of At-Home STD Testing
The benefits of at-home tests include:
The iHealth CheckMeSafe Home Collection kit delivers reliable results of up to 99.9% sensitivity for HIV and 99.5% for syphilis. Samples are processed and analyzed in a CLIA-certified and CAP-accredited laboratory, meaning they have met rigorous state and federal standards and undergo regular inspections for quality and accuracy in testing.
“Our solution kit is a convenient and discreet way to get tested for HIV and syphilis from the comfort of one’s home and rapidly receive highly accurate results,” noted Feng. “In an era of steadily increasing STD rates, this accessible and competitively-priced kit is a testament of iHealth’s dedication to providing healthcare solutions that meet critical needs in our communities.”
The iHealth CheckMeSafe Critical 2 Home Collection Kit is currently priced at a limited time offer of $59.99, 40% off its regular retail price of $99.99, with free shipping as well. For details and an FAQ on the solution or to purchase, visit: https://ihealthlabs.com/products/checkmesafe-critical2
About iHealth Labs, Inc.
iHealth is dedicated to empowering people to live healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud that allows consumers to easily measure, track, and share vital health information with their doctors. With a focus on delivering high-quality and accessible products, iHealth is at the forefront of the digital health revolution.
In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter sales. Since then, iHealth has emerged as a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. With its commitment to helping people lead healthier lives, iHealth is poised to continue driving positive change in the healthcare industry.
]]>This Donation will Assist the State's Fight Against COVID-19
SAN JOSE, Calif., July 25, 2022 (Newswire.com) - iHealth Labs, Inc., one of the major suppliers of at-home COVID tests in the U.S. market, is donating 1 million at-home COVID tests to the State of California. This donation will provide California's residents with much-needed support as another surge in coronavirus infections in the state has led to high demand for early detection.
"We have noticed that new subvariants, BA.4 and BA.5, have been spreading across the country for the past several months. While the new strains do not necessarily cause more severe illness, they are more contagious than the Omicron," said Jack Feng, iHealth CEO. "As the virus keeps evolving, regular testing has become part of the new normal. It is one of many things you can do to protect yourself and your family and reduce the chances of spreading the virus to others.
Jack continues, "iHealth has been at the forefront of the fight against COVID-19. Our commitment has been to bring at-home COVID-19 tests to more people as quickly as possible. However, as the number of new cases is rising again, our responsibility is to support the communities the best we can."
According to the related department, the 1 million tests donated will be distributed to schools when they reopen in the fall.
About the iHealth COVID-19 Antigen Rapid Test
The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
About iHealth Labs, Inc.
iHealth is dedicated to empowering healthier lives. As a pioneer of digital health from Silicon Valley, iHealth was founded in 2010 and launched the world's first Bluetooth-connected blood pressure monitor that worked with iOS devices. Through more than a decade of development, by integrating its FDA-approved, award-winning consumer medical devices and remote patient monitoring platform, iHealth has established a digital health ecosystem, the Unified Care model, for healthcare providers to manage chronic diseases remotely. To date, iHealth is one of the top brands in digital health & wellness and has expanded its Unified Care model to 13 states with significant clinical outcomes in hypertension and diabetes management.
During the first year of COVID-19 pandemic, iHealth was actively supporting the fight against COVID-19 by being one of the leading manufacturers of thermometers, shipping millions of them to its customers.
On November 5th, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over the counter (OTC) sale of iHealth's COVID-19 Antigen Rapid Test. iHealth has since been a major supplier of at-home tests to the federal government, state governments, nonprofit organizations, and individuals.
Visit www.ihealthlabs.com to learn more.
SUNNYVALE, Calif., February 14, 2022 - iHealth Labs, Inc., a leader in the design and manufacturing of consumer-friendly, mobile personal healthcare products, made its Super Bowl debut with in-stadium advertising highlighting its commitment to bring at-home COVID-19 tests to more people as quickly as possible. iHealth's Super Bowl advertising featured LED ribbon takeovers and branded openings on the stadium's video board that ran during the breaks at the end of the first and third quarters on Sunday, Feb. 13 at SoFi Stadium.
As a part of this sponsorship, iHealth worked with the National Football League to distribute 120,000 iHealth COVID-19 Antigen Rapid Tests to visitors at the Super Bowl Experience held at the Los Angeles Convention Center from Feb. 5 to 12, so that fans can test themselves before gathering to watch the big game.
"Testing remains an important tool in the fight against COVID-19, but this country is facing a severe testing shortage," said Jack Feng, iHealth Partner & COO. "We have been working with the federal and 20 state governments, as well as other organizations to make at-home testing more accessible. We have added an additional 16,000 manufacturing workers and scaled our production capacity to more than 10 million tests a day to achieve this goal. In addition, the iHealth team has been working around the clock to fulfill orders from our government and corporate partners, as well as meet the demand from the general public. Our company's goal is to bring COVID-19 tests to every American family in a timely manner."
About the iHealth COVID-19 Antigen Rapid Test
The iHealth COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
About iHealth Labs, Inc.
iHealth is dedicated to helping people lead healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud. It focuses on delivering high-quality products that are easy to use, making it simple for consumers to accurately measure, track, and share a full range of health information with their doctors.
During the first year of COVID-19 pandemic, iHealth was actively supporting the fight against COVID-19 by being one of the leading manufacturers of thermometers, shipping millions of them to its customers.
On Nov. 5, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over the counter (OTC) sale of iHealth's COVID-19 Antigen Rapid Test. iHealth has since been a major supplier of at-home tests to the federal government, state governments, nonprofit organizations, and individuals. In January 2022, iHealth received a $1.3 billion federal contract to deliver more tests to American families.
The FDA has Issued an Emergency Use Authorization (EUA) for this New User-Friendly Test Kit; Testing at Home is Now Easier and Faster than Finding a Testing Site
SUNNYVALE, Calif., November 5, 2021 - iHealth Labs, Inc., a leader in the design and manufacturing of consumer-friendly, mobile personal healthcare products, announced today the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for over the counter (OTC) sale of iHealth's COVID-19 Antigen Rapid Test. This self-test is suitable for individual or group testing anytime, anywhere, and delivers test results in 15 minutes at home. It is authorized and available for purchase at iHealthLabs.com in packages of two test kits.
"During COVID, how to get tested quickly has presented a dilemma for many people," said Jack Feng, iHealth partner. "For example, if you or your child does not feel well when your family is traveling for the upcoming holidays, do you make an appointment for a drive-through PCR test? While waiting for your results, should you isolate yourself or continue your trip? A typical test for COVID-19 can take up half a day or more, making it time-consuming, inconvenient and expensive to get tested. Our COVID-19 Antigen Rapid Test is an easy, inexpensive alternative that determines whether or not an individual has the disease in just 15 minutes anywhere - thereby limiting the spread of COVID-19."
Jack continues, "Our current production capacity is 100 million COVID-19 tests per month, with the expectation to produce 200 million tests a month starting in January 2022. Employers and other groups can now affordably and efficiently offer free regular testing within their organization. This is even more important today given everyone, regardless of vaccination status, can become infected and spread COVID-19 today. This allows everyone to move into a new era of COVID testing and together build a public health defense line against COVID-19 as life returns to normal at work in offices, for travel, and at school."
"With schools already back in session and the Delta variant that has been circulating persistently, the ability to affordably and quickly test at home is important for families," Jack added. "What are families to do when there is a positive COVID test report at their children's school? Thanks to our rapid antigen test, families can easily test over several days to ensure no one is infected. A new era of COVID testing is about to begin once we make self-test available and affordable to families. Careful monitoring of your family's health and weekly testing are great options for parents and caregivers in preventing the spread of COVID-19."
Each of the two single-use test kits comes with everything needed to conduct a COVID-19 test. The test uses a non-invasive swab to minimize any discomfort when collecting a sample. An iHealth COVID-19 Antigen Rapid Test app is available for iOS or Android phones. The app contains specific step-by-step video instructions to complete the test. Based on the clinical trial results, where the iHealth test was compared to an FDA-authorized molecular SARS-CoV-2 test, the iHealth test correctly identified 94.3% of positive specimens and 98.1% of negative specimens.
About the iHealth COVID-19 Antigen Rapid Test
The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
The iHealth COVID-19 Antigen Home Test Kit has not been FDA cleared or approved. It has been authorized by the FDA under an Emergency Use Authorization. It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated, or the authorization is revoked sooner.
About iHealth Labs, Inc.
iHealth is dedicated to helping people lead healthier lives. The company is a leader in designing and manufacturing consumer-friendly, mobile personal healthcare products connected through the cloud. It focuses on delivering high-quality products that are easy-to-use, making it simple for consumers to accurately measure, track, and share a full range of health vitals. By connecting the data through the cloud, consumers are able to see a more comprehensive view of their vitals, easily share data with health care professionals or caregivers, and take an active role in managing their health. All iHealth products sync directly with its free mobile app that simplifies comprehensive monitoring, viewing, storing, and sharing of health vitals. During the COVID-19 pandemic, iHealth was actively supporting the fight against the COVID-19 pandemic by being one of the leading manufacturers, shipping millions of thermometers to its customers.
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