NEVE ILAN, Israel--(BUSINESS WIRE)--NANO-X IMAGING LTD ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, received FDA 510(k) clearance for HealthOST device, an AI software that provides qualitative and quantitative analysis of the spine from CT to support clinicians in the evaluation and assessment of musculoskeletal disease. Measurements of vertebral fractures and low bone density have been shown to increase the identification of patients with musculoskeletal disease of the spine, such as osteoporosis, a disease that affects more than 10 million people in the U.S.1
This is Nanox.AIs tenth FDA clearance across its innovative portfolio of AI clinical decision assist tools and second FDA clearance for its vertebral compression fracture device. HealthOST offers a more detailed evaluation, including the ability to measure fractures more precisely, potentially aiding clinicians in evaluating risk factors for osteoporosis. The companys latest AI solution automatically identifies findings suggestive of compression fractures and low bone density, enabling further work up and treatment of patients diagnosed with osteoporosis to prevent potentially life-changing major osteoporotic fractures, such as a hip fracture. Nanox.AI previously received FDA clearance in May 2020 for the AI software that identifies vertebral compression fractures.
With the FDA clearance of HealthOST, we are thrilled to offer radiologists a new tool that provides deeper analysis of medical images to support identifying those patients who may be at-risk of developing prevalent musculoskeletal conditions such as osteoporosis, to help promote further work up and treatment of those patients, said Pini Ben Elazar, General Manager of Nanox.AI. Our new product reflects our vision to create solutions to improve population health, building upon our strong track record of developing AI applications to help identify risk factors for chronic health conditions.
According to the World Congress of Osteoporosis, 75% of compression fractures are missed or not reported. According to the CDC, approximately 10.2 million adults in the U.S. have osteoporosis while 43.3 million more have low bone density.1 Evidence suggests that there is a 25% mortality rate reported within one year of a patient sustaining a hip fracture.2
This FDA clearance is yet another step in our commitment to delivering technologies that promote population health and value-based care, said Erez Meltzer, Chief Executive Officer of Nanox. AI technologies like HealthOST are poised to support routine clinical decision making and potentially improve patients health outcomes.
HealthOST provides qualitative and quantitative analysis of the spine, including labelling of T1-L4 vertebrae, measurement of height loss in each vertebra (T1-L4) and measurement of the mean Hounsfield Units (HU) in volume of interest within vertebra (T11-L4). HealthOST is indicated for use in patients aged 50 and over undergoing CT scan for any clinical indication that includes at least four vertebrae in the T1-L4 portion of the spine (for vertebral height loss) and T11-L4 (for bone attenuation) portions of the spine.
Nanox.AIs portfolio also includes HealthCCSng, an FDA-cleared AI cardiac imaging solution that quantifies coronary artery calcium (CAC), to identify patients potentially at risk for a cardiovascular event, to promote further work up and possible treatment for cardiac disease.
About Nanox
Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. The vision of Nanox is to increase the early detection of medical conditions that are discoverable by medical image technologies based on X-rays, which we believe is key to increasing early prevention and treatment, improving health outcomes, and, ultimately, saving lives. We are developing a holistic imaging solution, which includes the Nanox System, comprised of the Nanox.ARC using our novel MEMs X-ray source technology, and the Nanox.CLOUD, a companion cloud software, integrated with AI solutions and teleradiology services. Our vision is to increase early detection of medical conditions that are discoverable by X-ray by improving access to imaging, reducing imaging costs, and enhancing imaging efficiency, which we believe is key to increasing early prevention treatment, improving health outcomes and ultimately saving lives. For more information, please visit http://www.nanox.vision.
About Nanox.AI
Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit http://www.nanox.vision/ai.
Forward-Looking Statements
This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company's research and development, manufacturing and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of the acquisitions, and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as can, might, believe, may, estimate, continue, anticipate, intend, should, plan, should, could, expect, predict, potential, or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management's good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (1) the inability to successfully integrate the acquired companies business, (2) the inability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees, (3) costs related to the acquisitions and/or unknown or inestimable liabilities, (4) changes in applicable laws or regulations that impact the operations of the acquired companies, (5) the failure to meet projected technology development targets, (6) the failure of the acquired companies to effectively scale end-to-end medical imaging solutions worldwide, (7) changes in global, political, economic, business, competitive, market and regulatory forces, and (8) (i) Nanoxs ability to successfully demonstrate the feasibility of its technology for commercial applications; (ii) Nanoxs expectations regarding collaborations with third-parties and their potential benefits; and (iii) Nanox's ability to conduct business globally, among other things.
For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanoxs actual results to differ from those contained in the Forward-Looking Statements, see the section titled Risk Factors in Nanoxs Annual Report on Form 20-F for the year ended December 31, 2020 and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release.
Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this report to conform these statements to actual results or to changes in the Company's expectations.
______________________________1 Osteoporosis or Low Bone Mass in Older Adults: United States, 20172018. Centers for Disease Control and Prevention. Updated March 31, 2021. Accessed April 26, 2022. https://www.cdc.gov/nchs/products/databriefs/db405.htm 2 Schnell S, Friedman SM, Mendelson DA, Bingham KW, Kates SL. The 1-year mortality of patients treated in a hip fracture program for elders. Geriatr Orthop Surg Rehabil. 2010;1(1):6-14. doi:10.1177/2151458510378105
See the original post:
Nanox Announces FDA Clearance for HealthOST Device, an AI Software Measuring Vertebral Compression Fractures and Low Bone Density, Which are Often...
- Stem Cell Treatment Anti Aging - Video [Last Updated On: November 12th, 2011] [Originally Added On: November 12th, 2011]
- Stem Cell Treatment Anti Aging - Video [Last Updated On: November 29th, 2011] [Originally Added On: November 29th, 2011]
- cord blood | Cord Blood Cells - Advantages Of Extracting Stem Cells From Umbilical Cord - Video [Last Updated On: November 14th, 2012] [Originally Added On: November 14th, 2012]
- Stritch School of Medicine Department of Preventive ... [Last Updated On: May 23rd, 2015] [Originally Added On: May 23rd, 2015]
- preventative medicine | Michigan Associates of Acupuncture ... [Last Updated On: June 20th, 2015] [Originally Added On: June 20th, 2015]
- Preventive Medicine - Miami Children's Hospital [Last Updated On: July 3rd, 2015] [Originally Added On: July 3rd, 2015]
- Preventive healthcare - Wikipedia, the free encyclopedia [Last Updated On: August 26th, 2015] [Originally Added On: August 26th, 2015]
- Preventive healthcare - Wikipedia, the free encyclopedia [Last Updated On: August 26th, 2015] [Originally Added On: August 26th, 2015]
- Nicklaus Children's Hospital - Preventive Medicine [Last Updated On: August 29th, 2015] [Originally Added On: August 29th, 2015]
- Look at recruitment as Preventative Medicine - RMG [Last Updated On: August 31st, 2015] [Originally Added On: August 31st, 2015]
- Physician Preventive Medicine Jobs :: Physician Preventive ... [Last Updated On: August 31st, 2015] [Originally Added On: August 31st, 2015]
- Preventive and Clinical Medicine [Last Updated On: August 31st, 2015] [Originally Added On: August 31st, 2015]
- Preventive Medicine - Home [Last Updated On: October 2nd, 2015] [Originally Added On: October 2nd, 2015]
- American Board of Preventive Medicine - a Member Board ... [Last Updated On: October 30th, 2015] [Originally Added On: October 30th, 2015]
- One Vet's Opinion On Marijuana As Medicine For Your Pet - The Fresh Toast [Last Updated On: August 27th, 2017] [Originally Added On: August 27th, 2017]
- Trump administration halts study on coal mining's impact on health - Roanoke Times [Last Updated On: August 27th, 2017] [Originally Added On: August 27th, 2017]
- Karavasilis joins Lahey Health Primary Care in Beverly - Wicked Local Beverly [Last Updated On: August 27th, 2017] [Originally Added On: August 27th, 2017]
- Find balance, and coffee, at Blend Cafe and Yoga - Fall River Herald News [Last Updated On: August 27th, 2017] [Originally Added On: August 27th, 2017]
- Preventive healthcare - Wikipedia [Last Updated On: June 21st, 2018] [Originally Added On: June 21st, 2018]
- "M*A*S*H" Preventative Medicine (TV Episode 1979) - IMDb [Last Updated On: September 7th, 2019] [Originally Added On: September 7th, 2019]
- Revealed: the UAE's best and worst gov't centres - ArabianBusiness.com [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Racial Disparities in Survival Outcomes Shown in Pediatric Hodgkin Lymphoma Patients - Newswise [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- New documentary claims eating meat could kill you - Yahoo News Australia [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- 4 Steps Healthcare Organizations Need to Take to Automate Their Data - - HIT Consultant [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Have DNA? These Yale geneticists want it - Yale Daily News [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Research suggests how environmental toxin produced by algae may lead to ALS - Penn State News [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Oak Knoll to Host ACL Prevention and Recovery Panel - Patch.com [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Screening for Mucin Gene Mutation May Lead to Personalized IPF Prevention Therapy, Researcher Says - Pulmonary Fibrosis News [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- The First Phone Network Exclusively for Kids Aims to Curb Screen Time Addiction - Yahoo Lifestyle [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Model Shows How Algal Toxin May Cause ALS - Technology Networks [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Migraine sufferers needlessly enduring agonising pain | ANU Science, Health & Medicine - ANU Science [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- St. Charles County Department of Public Health to Host a Bioterrorism Response Exercise - The Boone Country Connection [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- BioXcel Therapeutics Announces BXCL501 Program Initiative for Prevention and Treatment of Acute Agitation using Wearable Digital Devices - Yahoo... [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Rutgers hopes new athletic facility boosts both Scarlet Knights, sports medicine program (SLIDESHOW) - ROI-NJ.com [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Cattle Production Veterinarian Hall of Fame Inducts Johnson, Glock - Bovine Veterinarian [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- New technology paves the way for needle-free flu vaccine - Health Europa [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- DNA Testing Can Help Detect Possible Health Risks; Genetics Is Not A Crystal Ball - CBS Chicago [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- New warning about vaping-related lung illnesses in Maryland - WBAL TV Baltimore [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Tandem Diabetes: Bullish As Innovations Capitalize On A Booming Sector - Seeking Alpha [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Oncologist Edith Mitchell Wins PHL Life Sciences Ultimate Solution Award - Philadelphia magazine [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Monty Tech Veterinary Clinic opens for business - Sentinel & Enterprise [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Comer Education Campus Unveils New Soccer Field In Grand Crossing - Block Club Chicago [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- On the move at PB Bell, NAI, Javelina, TOCA, UA - AZ Big Media [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Drug Packaging Error in Spain Caused at Least 17 Hypertrichosis Cases in Children - Medscape [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Research Finds Needleless Flu Vaccine Patch to be Effective - DocWire News [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- "That which is to give light ... Suicide among animal welfare workers - Valencia County News Bulletin [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Shinrin Yoku and Mindfulness Its Not Just a Walk in the Park - Thrive Global [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Duke Field focusing on preventative health conditioning - 62nd Airlift Wing [Last Updated On: September 20th, 2019] [Originally Added On: September 20th, 2019]
- Surprising 'everyday' factors that affect mental health - Rising Sun Chatsworth [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- Shocking every day factors that can cause mental illness - East Coast Radio [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- MedStar Montgomery Opens New Oncology and Breast Health Centers - Patch.com [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- Infographic: Is nanotechnology the future of medicine? - Techaeris [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- This Social Security Change in 2020 Will Happen for Only the 10th Time in 85 Years - The Motley Fool [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- Rowan community hosts first annual Fitness Festival to promote fitness and ALS awareness - The Whit Online [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- How the Salton Sea Became an Eco Wasteland - HowStuffWorks [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- Earth Animal gets a new home on Post Road - Westport News [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- Researchers publish comprehensive review on respiratory effects of vaping - Taylorsville Times [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- Senior Expo provides information and wellness testing for Newton and Jasper - Newsbug.info [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- Bad Posture Could Be The Cause Of Your Back Pain & Headaches - CBS New York [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- How Nutrition-Tech Could Save Our Healthcare System And Billions Of Lives Around The World - Forbes [Last Updated On: October 13th, 2019] [Originally Added On: October 13th, 2019]
- BT, UHB demonstrate 5G-connected ambulance in Birmingham - Government Computing Network [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- Genome editing: a broad perspective on a precision technology - PHG Foundation [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- Breaking Down The Invitae Short (Podcast Transcript) - Seeking Alpha [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- To Reinvent Healthcare, Stop Treating Patients and Start Building Communities - Singularity Hub [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- Village Health Partners Merges with Texas Family Medicine - D Healthcare Daily [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- A guide to CBD topicals, balms, and lotions - Leafly [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- Smart toilet could help in healthcare - KRON4 [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- Chronic Inflammation Is a Huge Problem. But This Specialized CBD for Inflammation Can Help. - Futurism [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- 10 Years In The Making, New Stanford Hospital Officially Opens - Patch.com [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- Student Health Services offers preventative medical care for Aggies traveling abroad - Texas A&M The Battalion [Last Updated On: November 20th, 2019] [Originally Added On: November 20th, 2019]
- How Gluten Destroys the Human Body - The National Interest Online [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- Heart attack: This cooking oil has been proven to prevent the life-threatening condition - Express [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- ViiV Healthcare announces exclusive licensing agreement with the National Institutes of Health for investigational bNAb with potential for long-acting... [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- The Bedpan: 'The problem with conceding to Simon Stevens' - Health Service Journal [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- A New Frontier in Family Health and History - The Nation Newspaper [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- Treating 'suicidality' as its own medical condition could spur research, better treatment options - Genetic Literacy Project [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- electroCore to Present at the Two December Investor Conferences - Yahoo Finance [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- Keeping the Radio City Rockettes on their toes, with help from Westchester - Lohud [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- Remodeled Winn-Dixie opens in Zephyrhills, and other Pasco business news - Tampa Bay Times [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]
- Dallas Cowboys Battle the Flu Ahead of Their Biggest Game of the Year in Chilly New England - Newsweek [Last Updated On: November 26th, 2019] [Originally Added On: November 26th, 2019]