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HistoSonics Announces First Patient Treated in European Clinical Trial

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HistoSonics, developer of a non-invasive platform and novel sonic beam therapy, announced today that the first patient has been treated as part of the company’s #HOPE4LIVER Europe Trial, which was approved by German authorities earlier in the year.

The study is designed to evaluate the safety and efficacy of the HistoSonics’ platform technology, which uses the novel science of histotripsy and the mechanical properties of therapeutic focused ultrasound, to destroy unwanted tissue, including targeted primary and metastatic liver tumors, without the need for incisions or invasiveness.  The #HOPE4LIVER Europe Study is a multi-center, open label, single arm trial planned to enroll up-to 45 patients throughout sites in Spain, Italy, UK, and Germany, and is being run in parallel with a similar US trial.

HistoSonics’ non-invasive platform combines advanced imaging and proprietary software to deliver patient specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues at sub-cellular levels.  The company believes that the novel mechanism of action of their proprietary technology, intended to avoid thermal necrosis and ionizing radiation, may provide significant advantages to patients, including the ability of the treatment site to recover and resolve quickly, as well as provides physicians the unique ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

The procedure was performed at the Otto von Guericke University Clinic Magdeburg by Professor Dr. med. Maciej Pech, Interventional Radiologist, Director of University Clinic for Radiology and Nuclear Medicine and Principal Investigator of the #HOPE4LIVER site in Magdeburg, Germany. Professor Pech commented, “The first treatment in the #HOPE4LIVER was successful in destroying the targeted tumor and the patient performed well both during and after the procedure. We will follow up with the patient per the trial protocol and look forward to enrolling more patients that may be good candidates for histotripsy therapy. The ability to use histotripsy to destroy tumors completely and non-invasively could represent a tremendous advantage for many patients.”

Only 20%-30% of patients with liver tumors are eligible for surgical resection due to the presence of multiple tumors, underlying poor liver function, or general health issues limiting the success of surgery.  Primary liver tumors were the third leading cause of tumor related death worldwide in 2020, with approximately 906,000 new cases and 830,000 deaths globally, and 5-year survival rates less than 18%.  Additionally, the liver is second only to lymph nodes as the most common site of metastatic tumors, those that spread from other organs, and estimated to be present in up-to 70% of patients with advanced disease from another site.  Histotripsy may provide benefits to these patients due to its unique non-invasive, non-thermal, and non-ionizing destructive capabilities.

HistoSonics‘ Vice President of Medical Affairs, Joe Amaral, M.D., added, “It is extremely exciting to be working with Professor Pech and the team at Otto con Guericke University Clinic in Magdeburg to build upon the company’s initial success of the THERESA Study conducted in Spain.  We believe our non-invasive platform and novel therapy has the potential to change the experience for patients with solid liver tumors, and our aim is to continue to build this evidence with the #HOPE4LIVER Trials.  We are very thankful to Professor Pech and the entire team in Magdeburg for their continued commitment to clinical research and providing leadership in this important trial.”

The HistoSonics device is investigational and is not available for sale in the United States or Europe. It is limited to investigational use in the approved IDE and European studies.

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Source: https://infomeddnews.com/histosonics-first-patient-european-clinical-trial/

Medical Devices

OraSure and the Will Rodgers Liver Health Foundation to Heighten Awareness Around the Importance of Hepatitis C Testing

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Over Half of the Almost Three Million Americans with Hepatitis C Are Not Aware of Their Disease Status

BETHLEHEM, Pa. and HUNTERSVILLE, N.C., June 14, 2021 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it is collaborating with the Will Rodgers Liver Health Foundation to increase awareness around the role Hepatitis C (HCV) plays in chronic liver disease and promoting testing services for HCV within the United States. The U.S. Centers for Disease Control estimates that approximately 2.4 million individuals in the United States have HCV, and over half of these individuals currently don’t know their disease status. Left untreated, HCV often leads to liver cirrhosis, liver cancer, and liver failure. These outcomes are preventable given new antiviral drugs that can effectively cure patients, but early diagnosis through increased testing is vital to eradicating this disease. According to data from the National Institutes of Health, healthcare costs associated with chronic HCV infection are $6.5 billion per year in the United States today and continue to rise, representing a substantial burden on our healthcare system.

“As a liver disease patient who endured Primary Sclerosing Cholangitis as a child, and through friends affected by HCV, I know the toll liver disease can have on your body, especially if it’s left untreated,” Will Rodgers, NASCAR driver, said. “This terrible disease, which affects so many in the United States, is a significant strain on our healthcare system, and could be eradicated through broad scale testing initiatives. “I’m very proud to work with OraSure to drive increased awareness around HCV and provide testing services to underserved communities across the country.”

“At OraSure, we take public health seriously and have played a significant role in combating diseases such as HCV, HIV, and COVID-19 on a global basis. Our OraQuick® HCV rapid antibody test is designed to be extremely simple to use, highly accurate and provides a result within 20 minutes, while simultaneously being cost effective,” said OraSure President and CEO Stephen Tang, Ph.D. “As a company, we are extremely proud to collaborate with the Will Rodgers Liver Health Foundation to drive greater awareness around the importance of individuals knowing their HCV status. A simple test can save a life.”

As a 3-year-old child, Rodgers was diagnosed with Primary Sclerosing Cholangitis, an extremely rare, chronic liver disease. While the disease has no present cure, his disease abated after two years of treatment, to the delight of his physicians and family. Following the end of his treatments, Rodgers’ racing journey began to take shape.

As a first generation race car driver, Rodgers was introduced to go-kart racing at the age of eight and within 18 months was the reigning Hawai’i state champion and track record holder in Maui. From there, Rodgers became a regional champion in motocross, a stadium series champion in off-road UTVS and a 2015 West Coast NASA champion in sports car racing. In 2016, Rodgers became the winningest driver in the Pirelli World Challenge Pro B Spec class. These personal achievements paved the way for his current career in NASCAR, where he has gone on to become a winner in both the ARCA Menards Series East (2017-2018) and the ARCA Menards Series West (2018).

Inspired by Will Rodgers personal endurance with liver disease, the Will Rodgers Liver Health Foundation was formed in 2020 to fill gaps for those affected with liver health issues by providing education, testing resources, and a link to care. The Will Rodgers Liver Health Foundation’s vision is to build awareness and provide education of liver disease, remove any barriers for treatment of liver diseases from targeted demographics, provide link-to-care in targeted communities, and eliminate the negative stigma surrounding liver disease.

The foundation’s effort, driven by Rodgers, is culminating into his overall vision — a brand new philanthropic campaign to raise awareness for HCV — RaceToEndHepC.com.

“A major element of the Race To End Hep C initiative is the at-track and in-community activation space. It’s important to reach the communities affected by HCV, in person, to communicate the importance of education, testing and treatment. Together, with our supporting partners, we’ll be providing a step-by-step process for any individuals wanting to learn more about HCV and how we’re Racing to End it.”

The Will Rodgers Liver Health Foundation will provide an interactive environment at race events and select community locations to encourage liver health. Through his collaboration with OraSure, individuals will be provided with free HCV testing, which allows you to receive your results in minutes with a simple finger prick, educational materials and resources to take the next step for those with liver health needs.

To find a community event near you, visit www.RaceToEndHepC.com.

About HCV and the OraQuick® HCV Rapid Antigen Test
According to the CDC, HCV is the most common chronic blood-borne infection in the United States, with approximately 2.4 million people infected. It is estimated that one in 30 Baby Boomers (adults born between 1945 and 1965) have chronic Hepatitis C and over half of the people infected with HCV in the United States are unaware of their infection. The CDC, the U.S. Preventive Services Task Force (USPSTF), and the American Association for the Study of Liver Diseases (AASLD) have all issued guidance that recommends HCV testing for at-risk individuals including all Baby Boomers.

OraQuick® HCV is the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple platform enables healthcare providers to deliver a diagnosis based on lab-accurate test results in 20 minutes, using venipuncture or fingerstick blood.

About the Will Rodgers Liver Health Foundation
By uniting the healthcare industry, the Will Rodgers Liver Health Foundation (WRLHF) seeks to build awareness and provide education on liver disease, remove any barriers for treatment of liver diseases for targeted demographics, provide link-to-care in targeted communities, and eliminate negative stigma surrounding liver disease. The WRLHF fills a need for a national, far-reaching campaign, coupled with a true ambassador for liver health. The foundation focuses on consumable education for the public, provides on-site & in-the-field testing and links patients with proper care. Additionally, the WRLHF stands to change the public’s negative perception of liver disease and has a goal to positively change the conversation. For more information on the Will Rodgers Liver Health Foundation, visit www.liverhealth.foundation.

About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Important Information

This press release contains certain forward-looking statements, including with respect to expected revenues, products, product development activities, regulatory submissions and authorizations and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management’s attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on our business and our ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

Media Contact:   Investor Contact:
Jessica O’Brien   Scott Gleason
803-240-5807   SVP Investor Relations & Corp. Comms.
jessica@truexmanagementgroup.com   484-425-0588
    sgleason@orasure.com
     
Will Rodgers Liver Health Foundation Contact:   Media Contact:
Karleen Margenean   Amy Koch
586-839-7417   Sr. Mgr. Corporate Communications
    484-523-1815
    media@orasure.com

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Source: https://www.biospace.com/article/releases/orasure-and-the-will-rodgers-liver-health-foundation-to-heighten-awareness-around-the-importance-of-hepatitis-c-testing/?s=93

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New Research Shows Nearly Half of Elderly Suffer Decreased Mobility During Lockdown

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Decreased Mobility During Lockdown: Kepler Vision Technologies, a global leader in computer vision monitoring technology, reveals that while people are still concerned about the possibility of elderly relatives catching Covid, day-to-day concerns such as loneliness, mental health and falling over are of an almost equal concern according to new research.

decreased mobility during lockdown, Kepler Vision Technologies

Parental Loneliness and Falls a Huge Worry for Brits

In a survey of UK adults with parents over the age of 75, while over half (52%) of respondents remain worried about their parents catching Covid, 48 percent are concerned about parental loneliness, and 46 percent about their parents falling alone and not being able to get up or get help. This figure remained high even among those whose parents are in care homes, with 37% of respondents still most concerned about parents falling over.

Physical Mobility in Elderly People Massively Impacted During Lockdown

There is also concern that the long-term effects on the mental and physical health of the elderly are still being felt. Four in ten respondents (41 percent) revealed that their parent’s physical fitness and mobility have decreased during the lockdown, as a result of being confined to homes for months at a time with little opportunity to exercise or physically engage with others.

Dr. Harro Stokman, CEO of Kepler Vision Technologies said: “With fears about Covid beginning to recede, those with older relatives are rightly concerned with the more common problems faced by the elderly both in care and while living alone. Issues such as loneliness and falling over are both exacerbated by the ongoing staffing crisis in the care industry and, with no new influx of care staff on the horizon, the children of elderly parents should be looking for solutions that provide them with the best possible care and dignity in their old age.”

Getting up from the floor after a fall is a challenge for the elderly. According to a study on the effects of falling among elderly people[1], even when not injured, 47% cannot get up without assistance. Remaining on the floor after a fall for a prolonged period increases morbidity and mortality, with an early study [2] finding that half of those who remained on the floor after a fall for an hour or longer passed away within 6 months. Another study [3] showed that 60% of those who were on the floor after a fall for more than an hour were admitted to the hospital in the follow-up year.

Kepler Vision’s Night Nurse solution is designed to alert relevant staff or carers immediately to elderly people that have experienced a fall, ensuring that they get assistance within minutes not hours, reducing the chances of further injury and health complications.

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Source: https://infomeddnews.com/decreased-mobility-during-lockdown-elderly-suffer/

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British Columbia First Province to Cover Dexcom G6 Continuous Glucose Monitoring System for People With Type 1 and Type 2 Diabetes on Intensive Insulin Therapy

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BURNABY, British Columbia–(BUSINESS WIRE)– Dexcom, Inc. (NASDAQ: DXCM), a leader in real-time continuous glucose monitoring (CGM), announced today that people with diabetes who are on intensive insulin therapy, age two years or older, may now be eligible for provincial coverage of the Dexcom G6 CGM System through BC PharmaCare. This coverage expansion is in line with Dexcom’s mission to make it easier for people living with diabetes to experience the benefits of using a CGM system for their diabetes management.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005428/en/

The Dexcom G6 CGM System now covered by BC PharmaCare for people living with diabetes who are on intensive insulin therapy. Back of the upper arm wear is available for users 18+. (Photo: Business Wire)

The Dexcom G6 CGM System now covered by BC PharmaCare for people living with diabetes who are on intensive insulin therapy. Back of the upper arm wear is available for users 18+. (Photo: Business Wire)

“Improved access to CGM technology elevates diabetes management for everyone in a patient’s circle of care. As an endocrinologist and medical director at a clinic specifically dedicated to diabetes care, I am appreciative that today’s announcement will benefit so many people in the province,” said Dr. Tom Elliott, Medical Director of B.C. Diabetes. CGM leads to better glycemic control for patients1,2 and gives physicians better insight into patients’ glucose levels to make treatment decisions. CGM use may lead to fewer trips to the emergency room by helping users avoid severe hypoglycemic episodes.4

British Columbia joins Yukon, Quebec and Saskatchewan to offer public coverage of CGM systems under provincial health plans. In addition, Prince Edward Island and Manitoba have also recently announced plans for funding based on their 2021 budget platforms. For coverage in B.C., patients must meet the coverage criteria, be enrolled in eligible PharmaCare plans, and meet any deductible requirements. Today’s announcement marks a significant accomplishment in increasing access to life changing technology used in the management of diabetes and recognizes the impact CGM technology can have on those who require intensive insulin therapy to manage their type 2 diabetes as well as those living with type 1 diabetes.

“As a BC-based company, we are thrilled by today’s announcement and the province’s commitment to the diabetes community,” says Laura Endres, Vice President and General Manager of Dexcom Canada. “We have seen the impact of improved access to CGM to truly change lives, and we look forward to continuing our work toward access for all those impacted by diabetes across Canada.”

The Dexcom G6 CGM System includes a small, wearable sensor that measures glucose just below the skin; a transmitter to continuously and wirelessly send glucose levels to a display device; and a compatible smart device* or receiver that displays real-time glucose data to users without the need for fingersticks or scanning. And with real-time alerts, including a predictive Urgent Low Soon alert, the Dexcom G6 can warn the user in advance of hypoglycemia — allowing time to take appropriate action before it happens — day or night. As part of the BC PharmaCare coverage program, users will now be able to pick up their Dexcom CGM supplies through a participating local pharmacy.

For more information about the coverage criteria for BC PharmaCare, please visit https://www.dexcom.com/en-CA/public-coverage and BC PharmaCare’s website section related to Diabetes Supplies.

About Dexcom, Inc.

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California in the United States, and with operations in Canada, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.

If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

* For a list of compatible devices, please visit dexcom.com/compatibility

Dr. Tom Elliott was not compensated for any media work. He has been a paid speaker for Dexcom Canada, Co.

References


1 Beck RW, Riddlesworth T, Ruedy K, et al. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: The DIAMOND randomized clinical trial. JAMA 2017;317(4):371-8.

2 Welsh JB, Gao P, Derdzinski M, et al. Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems. Diabetes Technol Ther 2019;21(3):128-32.

3 Roze S, Isitt J, Smith-Palmer J, Lynch P. Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor Versus Self Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. Poster presentation presented at: 2020 Canadian Association for Population Therapeutics; October 27, 2020.

4 Mulinacci G, Alonso GT, Snell-Bergeon JK, Shah VN. Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes. Diabetes Technol Ther 2019;21(1):6-10.

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Orthofix Announces Participation in Upcoming JMP Securities Life Sciences Conference

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June 11, 2021 11:01 UTC

LEWISVILLE, Texas–(BUSINESS WIRE)– Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced that President and Chief Executive Officer Jon Serbousek and Chief Financial Officer Doug Rice will participate in a fireside chat during the upcoming JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 11:00 a.m. ET. The conference will be held in a virtual format, and one-on-one meetings will be held before and immediately following the fireside chat.

A live audio webcast will be available on the Company’s website at ir.orthofix.com/events-and-presentations/.

About Orthofix

Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions while partnering with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics products are distributed in more than 60 countries via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210611005084/en/

Source: Orthofix Medical Inc.

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