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Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arc™ System

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3 months ago

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An automated platform designed to fight against Sepsis and Antimicrobial Resistance (AMR)

Enables rapid, automated microbial identification on the Bruker MALDI Biotyper® CA System directly from positive blood culture samples

TUCSON, Ariz., Sept. 30, 2024 /PRNewswire/ — Accelerate Diagnostics, Inc. (NASDAQ: AXDX), an innovator of rapid in vitro diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the Accelerate Arc system and BC kit, an innovative, automated positive blood culture sample preparation platform, for use with Bruker’s MALDI Biotyper® CA  System (MBT-CA System) and MBT-CA Sepsityper® software extension.

Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification (ID) using Bruker’s MBT-CA system. This eliminates the need for overnight culture methods, reducing the wait time for microbial ID results, which is critical in the fight against sepsis.

The Accelerate Arc system is designed to leverage the breadth of the Bruker MBT-CA reference library to provide rapid ID. This, in conjunction with our future rapid phenotypic antibiotic susceptibility testing (AST) innovation, the Accelerate WAVE™ system1, can enable same shift reporting to Antimicrobial Stewardship teams and clinicians alike. By providing clinicians with rapid ID and AST results, clinicians can get the patient on the optimal antibiotic therapy many hours sooner, which has been shown to improve patient outcomes with Sepsis, reduce antimicrobial resistance rates and hospital costs.

The Accelerate Arc system is also designed to supplant both overnight subculture as well as laborious Laboratory Developed Test (LDT) sample preparation methods. Clinical laboratories are under pressure to run FDA-cleared devices due to increased legislation and enforcement associated with the use of LDTs. Accordingly, such laboratories can now utilize the Accelerate Arc system as an automated, FDA-cleared system.

“The FDA Clearance of the Accelerate Arc system marks the beginning of an exciting journey in our broader innovation roadmap. Together with the Accelerate WAVE™ system1 we are positioned to empower laboratories to deliver faster, more actionable results to clinicians, ultimately enhancing patient care and outcomes.” said Jack Phillips, President and CEO of Accelerate Diagnostics.

About Accelerate Diagnostics, Inc. (Nasdaq: AXDX)

Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. In addition to the Accelerate Arc system, the Accelerate Pheno system and Accelerate PhenoTest® BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. The FDA-cleared Accelerate Pheno system and Accelerate PhenoTest BC kit fully automate sample preparation, identification and phenotypic antibiotic susceptibility testing in approximately seven hours directly from positive blood cultures. Recent external studies indicate the solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.

© Copyright 2024 Accelerate Diagnostics, Inc. All Rights Reserved. The “ACCELERATE DIAGNOSTICS,” “ACCELERATE PHENO,” “ACCELERATE PHENOTEST,” “ACCELERATE ARC” and “ACCELERATE WAVE” diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc. All other trademarks are the property of their respective owners.

For more information about the company, its products and technology, or recent publications, visit axdx.com.

Forward-Looking Statements

Certain of the statements made in this press release are forward-looking or may have forward-looking implications within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the company intends that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements, which can be identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate,” or “continue,” or variations thereon or comparable terminology, include but are not limited to, statements about: expectations regarding the potential or benefits of Accelerate Diagnostics’ products and technologies, including the Accelerate Arc system, such as the anticipated benefits to hospitals, patients, and laboratories, as well as the expectation that the Accelerate Arc system will eliminate the need for overnight culture methods and reduce the wait time for microbial identification results; expectations regarding new or planned products and technologies, including the anticipated timing of any releases, such as with respect to the Accelerate WAVE system currently under development; and intentions and plans relating to regulatory approvals or submission, including with respect to the FDA. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to significant risks and uncertainties, including, but not limited to: volatility throughout the global economy and the related impacts to the businesses of the company’s suppliers and customers, whether due to customer demand fluctuations, supply chain constraints and inflationary pressures or otherwise; difficulties in resolving the company’s continuing financial condition and ability to obtain additional capital to meet its financial obligations; the company’s ability to obtain any regulatory approvals; and less than expected operating and financial benefits resulting from cost cutting measures. Other important factors that could cause the company’s actual results to differ materially from those in its forward-looking statements include those discussed in the company’s filings with the Securities and Exchange Commission (the “SEC”), including in the “Risk Factors” sections of the company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. These forward-looking statements are also based on certain additional assumptions, including, but not limited to, that the company will retain key management personnel; the company will be successful in the commercialization of its products; the company will obtain sufficient capital to commercialize its products and continue development of complementary products; the company will be successful in obtaining marketing authorization for its products from the FDA and other regulatory agencies and governing bodies; the company will be able to protect its intellectual property; the company’s ability to respond effectively to technological change; the company’s ability to accurately anticipate market demand for its products; and that there will be no material adverse change in the company’s operations or business and general market and industry conditions. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing the company’s plans and expectations as of any subsequent date.

1 The Accelerate WAVETM system is currently in clinical trials in preparation for FDA 510(k) submission with a target time-to-result of 4.5-hours, on average.

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SOURCE Accelerate Diagnostics, Inc.

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As 2025 IRS Mileage Rate Hits 70 Cents, Expert Warns: Ditch Risky Apps for Secure Paper Tracking

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4 hours ago

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December 22, 2024

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Gig economy expert Ed Ryder warns against the risks of mileage tracking apps, and advocates using paper-based tracking methods instead. He introduces The Big Mileage Form, a secure alternative developed over two years to meet the specific needs of food delivery gig workers. Ryder highlights recent tech failures, like the July 2024 global IT outage, to underscore the vulnerabilities of digital solutions. The press release also mentions Ryder’s significant mileage deduction using his form and directs readers to GigCoach.net for additional resources, including a consumer tutorial to drive better food delivery outcomes and a gig coach training program.

PHILADELPHIA, Dec. 22, 2024 /PRNewswire-PRWeb/ — As the IRS announces a standard mileage rate of 70 cents per mile for 2025, gig economy expert Ed Ryder, who has completed over 10,000 deliveries with his own car using major food delivery platforms, urges fellow gig workers to reconsider their mileage tracking methods. While acknowledging the convenience of digital solutions, Ryder advocates for a return to secure, paper-based tracking to protect valuable mileage deductions.

With the mileage rate at 70 cents, accurate tracking is crucial for gig workers and small business owners. Mileage apps seem convenient, but they risk data loss from outages, glitches, and cyber attacks. Many overlook these significant dangers.

“With the mileage rate increasing to 70 cents, accurate tracking is more crucial than ever for gig workers and small business owners,” says Ryder, creator of The Big Mileage Form. “While mileage tracking apps seem convenient, they come with significant risks that many overlook. Network outages, app glitches, and cyber attacks can jeopardize months of data.”

Ryder points to the July 2024 global IT outage as a prime example of technology’s vulnerabilities. “A faulty software update caused mass airline disruptions and impacted other industries, catching major corporations off guard. This incident highlights that even in our digital age, software isn’t infallible. For me, I simply won’t trust mileage tracking apps with my most important tax deduction.”

To address these concerns, Ryder developed a comprehensive, paper-based solution. “I spent two years perfecting The Big Mileage Form, tailoring it to the specific needs of food delivery gig workers,” he explains. “At 11×17 inches, it provides ample space for detailed record-keeping and, crucially, it’s immune to software glitches, data breaches, and ransomware attacks.”

Ryder’s meticulous paper-based record-keeping resulted in a mileage deduction exceeding $19,000 on his 2023 federal taxes. “All my business-related miles are thoroughly documented on paper. I’m fully prepared to defend this deduction in case of an audit. This level of confidence is what I aim to provide other gig workers.”

“In today’s digital age, sometimes the most secure solution is the simplest one,” Ryder concludes. “My form not only ensures data security but also prepares users for potential IRS audits. It’s time to reconsider the old-fashioned, but reliable pen-and-paper method.”

For those interested in learning more about effective mileage tracking and other aspects of gig work, Ryder offers valuable resources on GigCoach.net. These include a tutorial for consumers titled ‘Fair Deal Delivery,’ which provides insights on how to improve food delivery outcomes. Additionally, experienced food delivery couriers can explore Ryder’s gig coach training program. Visit GigCoach.net to access these resources and learn more about The Big Mileage Form.

Media Contact

Ed Ryder, Match Experiment LLC, 1 484-493-8740, hello@ideamaned.com, gigcoach.net

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SOURCE Gig economy expert Ed Ryder

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DATA BREACH ALERT: Edelson Lechtzin LLP Is Investigating Claims On Behalf Of Ascension Health Customers Whose Data May Have Been Compromised

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4 hours ago

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December 22, 2024

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NEWTOWN, Pa., Dec. 22, 2024 /PRNewswire/ — The law firm of Edelson Lechtzin LLP is investigating claims regarding data privacy violations by Ascension Health (“Ascension”). Ascension learned of suspicious activity on or about May 8, 2024. To join this case, go HERE.

About Ascension Health

Ascension is a prominent non-profit health system in the nation and operates under Catholic principles.

What happened?

On or about May 8, 2024, Ascension detected unauthorized activity in its computer systems. Ascension initiated an investigation, which included retaining consulting cybersecurity experts and notifying the FBI. The investigation determined that between May 7 and 8, 2024, a cybercriminal accessed files containing personal information about Ascension’s patients and employees. This information included names, medical records, payment details, insurance information, government identification numbers, and other personal data such as dates of birth and addresses. Approximately 6 million individuals have been affected by this data breach.

How can I protect my personal data?

If you receive a data breach notification, you must guard against possible misuse of your personal information, including identity theft and fraud, by regularly reviewing your account statements and monitoring your credit reports for suspicious or unauthorized activity. Additionally, you should consider legal options for mitigating such risks.

Edelson Lechtzin LLP is investigating a class action lawsuit to seek legal remedies for customers whose sensitive personal and patient data may have been compromised by the Ascension data breach.

For more information, please contact:

Marc H. Edelson, Esq.
EDELSON LECHTZIN LLP
411 S. State Street, Suite N-300
Newtown, PA 18940
Phone: 844-696-7492
Email: medelson@edelson-law.com
Web:  www.edelson-law.com 

About Edelson Lechtzin LLP
Edelson Lechtzin LLP is a national class action law firm with offices in Pennsylvania and California. In addition to cases involving data breaches, our lawyers focus on class and collective litigation in cases alleging securities and investment fraud, violations of the federal antitrust laws, employee benefit plans under ERISA, wage theft and unpaid overtime, consumer fraud, and catastrophic injuries.

This press release may be considered Attorney Advertising in some jurisdictions. No class has been certified in this case, so counsel does not represent you unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing now. Your ability to share in any potential future recovery does not depend on serving as lead plaintiff.

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SOURCE Edelson Lechtzin LLP

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Earth’s pulse monitored: a review highlights remote sensing time series progress

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8 hours ago

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December 22, 2024

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As urbanization accelerates and environmental dynamics shift, the need for accurate and timely terrestrial monitoring has never been more urgent. A review has introduced a novel approach to remote sensing time series analysis, integrating multi-source data to enable near real-time monitoring. This innovative methodology promises to transform environmental conservation and urban planning by providing unprecedented insights into terrestrial changes and offering a more precise understanding of environmental dynamics.

GUANGZHOU, China, Dec. 22, 2024 /PRNewswire-PRWeb/ — An international team of researchers from South China Normal University, the University of Connecticut, and the Chinese Academy of Sciences has made a significant breakthrough in remote sensing. Their review, published (DOI: 10.34133/remotesensing.0285) in the Journal of Remote Sensing on December 11, 2024, addresses key challenges in remote sensing, such as incomplete data and noise interference. The team’s new time series analysis technique leverages advanced data reconstruction and fusion methods, significantly enhancing the precision and efficiency of remote sensing for monitoring environmental changes.

The research team has developed an advanced time series analysis technique that combines deep learning algorithms with traditional remote sensing methods to integrate data from various remote sensing sources. This innovative approach allows for the extraction of subtle patterns from large, complex datasets, which is crucial for monitoring critical environmental parameters such as land use and vegetation health. Unlike conventional techniques that struggle with incomplete or noisy data, this new methodology offers enhanced accuracy and more reliable insights into terrestrial dynamics, paving the way for more effective environmental monitoring.

Central to the study’s success is the integration of Long Short-Term Memory (LSTM) networks and Generative Adversarial Networks (GANs) to address the challenges posed by missing or noisy data. The LSTM networks capture temporal trends over time, while the GANs generate synthetic data that mimics real-world observations to fill gaps and correct for atmospheric distortions. This dual approach has resulted in a cleaner, more accurate time series dataset, which was validated against independent ground truth measurements. The researchers demonstrated significant improvements in key vegetation indices, such as the Normalized Difference Vegetation Index (NDVI), setting a new benchmark in the field of remote sensing.

Experts in the field have lauded the study’s potential to revolutionize remote sensing applications. They see the method as a transformative tool for enhancing high-resolution monitoring and extending its coverage, particularly in agricultural surveillance, urban planning, and environmental management. “This method represents a crucial advancement in our ability to monitor environmental changes,” says Professor Fu. “As it evolves, it could play a key role in addressing climate change and other global challenges.”

The methodology’s future applications are vast, especially in global environmental monitoring and supporting sustainable development goals. By integrating multi-temporal data from Landsat and Sentinel-2 satellites, the team has created a framework for accurate and continuous terrestrial analysis. As computational power advances and algorithms improve, this technology is expected to become a vital tool for natural resource management, disaster response, and climate change mitigation. In the years to come, it could provide critical data to help policymakers address pressing environmental issues on a global scale.

References

DOI

10.34133/remotesensing.0285

Oiginal Source URL

https://doi.org/10.34133/remotesensing.0285

Funding information

This work was supported by the National Nature Science Foundation of China (grant numbers 42425001 and 42071399).

About Journal of Remote Sensing

The Journal of Remote Sensing, an online-only Open Access journal published in association with AIR-CAS, promotes the theory, science, and technology of remote sensing, as well as interdisciplinary research within earth and information science.

Media Contact

George Hua, Chuanlink Innovations, 1 8656606278, TranSpread1@gmail.com, http://chuanlink-innovations.com/

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SOURCE Journal of Remote Sensing

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