Technology

Avicenna.AI secures MDR certification for medical imaging AI portfolio

Published

6 months ago

July 3, 2024

French AI company achieves key EU regulatory compliance for multiple algorithms that identify, detect, and quantify severe conditions from medical images.

LA CIOTAT, France, July 3, 2024 /PRNewswire/ — Avicenna.AI, a leading medical imaging AI company, has received Medical Device Regulation (MDR) certificate for five of its algorithms from certification body BSI Medical Devices. This development means the company’s product portfolio is fully compliant with the European Union’s MDR 2017/745, which is now mandatory for medical device companies that want to provide their solutions in Europe.

The MDR was introduced to update the EU’s regulations for medical devices, addressing safety issues and the recent emergence of AI tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, which allows a device to be freely traded in the EU.

Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management. These measures aim to enhance patient safety and ensure high standards for medical devices, including AI and software-based solutions.

Avicenna.AI’s products have been certified as Class IIb medical devices, which requires a high level of clinical validation. The certified products include the company’s suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.

“Obtaining MDR certification is a significant milestone for Avicenna.AI,” said Stéphane Berger, Regulatory Manager at Avicenna.AI. “It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio.”

The company’s MDR-certified AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), quantification of stroke severity (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE). All the products are also CE-marked and FDA-cleared.

“Crucially, despite the differences in SaMD regulatory requirements between authorities in the US and Europe, we are consistently achieving both FDA and CE mark clearance for our AI products,” added Berger.

All of Avicenna.AI’s AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.

About Avicenna.AI
Founded in 2018, Avicenna.AI specializes in providing healthcare AI solutions that utilize deep learning to identify, detect, and quantify severe pathologies from CT medical images. Co-founded by Cyril Di Grandi, a successful entrepreneur who previously co-founded Olea Medical, and Dr. Peter Chang, an internationally recognized radiologist, and an expert in AI and deep learning, Avicenna.AI aims to accelerate therapeutic decision-making processes and enhance patient outcomes through its AI-based radiology solutions. For additional details, stay connected with us on social media and explore Avicenna.AI’s website at www.avicenna.ai.

For more information, contact:
Stéphanie Bellavia, Marketing Manager, Avicenna.AI
Email: stephanie.bellavia@avicenna.ai

View original content:https://www.prnewswire.co.uk/news-releases/avicennaai-secures-mdr-certification-for-medical-imaging-ai-portfolio-302188932.html

Technology

Agoda Highlights Tokyo as Top Global New Year’s Eve Destination

Published

57 minutes ago

December 26, 2024

SINGAPORE, Dec. 26, 2024 /PRNewswire/ — Digital travel platform Agoda has announced Tokyo as the most popular destination for New Year’s Eve, based on accommodation searches. This marks a shift from last year when Taipei held the top spot. Following Tokyo, the list includes Bangkok, Taipei, Pattaya, and Osaka, showcasing a diverse range of preferences among travelers.

The data highlights a perpetual interest in Tokyo, a city known for its unique blend of tradition and modernity. Travelers are drawn to its vibrant celebrations, cultural experiences, and iconic landmarks. Bangkok and Taipei, too, continue to be favored destinations, offering rich cultural festivities and lively atmospheres. Pattaya and Osaka also make the list, appealing to those seeking beachside celebrations and culinary delights, respectively.

Agoda’s data reveals Tokyo’s prominence not only on a worldwide scale but also within Japan. Domestic accommodation searches have increased by 23%, with Tokyo leading as the preferred destination, followed by Osaka, Kyoto, Yokohama, and Okinawa Main Island. For Japanese traveling abroad, the destinations primarily considered are Taipei, Seoul, Bangkok, Pattaya, and Hong Kong.

Hiroto Ooka, Associate Vice President North Asia at Agoda said: “Tokyo’s rise to the top of Agoda’s New Year’s Eve destination list is a testament to the city’s global appeal. Whether you’re celebrating New Year’s Eve in Tokyo, Osaka, or anywhere else in the world, Agoda is ready to help you find the perfect spot to ring in the New Year.”

As travelers prepare for their New Year’s Eve plans, Agoda offers a comprehensive selection of over 4.5 million holiday properties, more than 130,000 flight routes, and over 300,000 activities, all available for seamless booking. Download the Agoda app for the latest deals or visit agoda.com/deals.

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SOURCE Agoda

Technology

SP Manufacturing Expands with New Malaysia Plant, Acquires Ideal Jacobs

Published

2 hours ago

December 26, 2024

SINGAPORE, Dec. 25, 2024 /PRNewswire/ — SP Manufacturing (SPM), a leader in Electronic Manufacturing Services (EMS), is strengthening its global presence with two major moves: opening a new manufacturing facility in Senai, Malaysia, and successfully acquiring Ideal Jacobs Corporation.

Malaysia Expansion: Enhancing Operations and Supporting Growth

The state-of-the-art Senai facility, which opened in October, will enhance the company’s operational resilience to meet growing customer demands in medical devices, industrial machinery, and automotive electronics.

Equipped with advanced automation and strict quality controls, the factory enables SPM to deliver mission-critical products with precision and reliability while supporting Malaysia’s vision of becoming a leader in high-value, high-tech industries.

“This facility reflects our commitment to serving our global customers while participating in a key location of the global supply chain network,” said Jackson Tan, Global Business Development Director of SP Manufacturing. The plant’s capabilities include cable harness assembly, PCB assembly, and box-build solutions.

The Senai facility is equipped with comprehensive manufacturing capabilities, including:

Functional testingIn-circuit testing and automated optical inspection (AOI)State-of-the-art cleaning processesRigorous inspection protocolsRapid prototyping and expert assembly processes

Ideal Jacobs Acquisition: Expanding Capabilities

In a parallel move, SPM also acquired Ideal Jacobs Corporation, which is known for its human-machine interface, printed electronics and die-cut solutions. The move will expand SPM’s engineering capabilities and provide access to a diversified client portfolio, including leading names in the medical, industrial, semiconductor, and telecommunications sectors.

Comprehensive Design Support in the U.S.

SPM continues to provide comprehensive engineering and design services for its U.S. customers using industry-standard software for PCB and electrical design. These services help clients with their new product introductions (NPI), early supplier involvement (ESI), and DFx processes, optimising costs and reducing time to market.

Founded in 2000 and headquartered in Singapore, SP Manufacturing has built its reputation serving mission-critical industries like medical, automotive, and aerospace. The company specialises in cable harnesses, PCB assemblies, and box-build products.

For more information about SP Manufacturing’s latest developments, visit www.sp-manufacturing.com or follow us on LinkedIn.

About SP Manufacturing

SP Manufacturing (SPM), founded in 2000 and headquartered in Singapore, has established itself as a leader in the EMS sector. Serving mission-critical industries such as industrial, medical, automotive, and aerospace, SPM excels in providing comprehensive manufacturing solutions from design to full production, specialising in high-quality cable harnesses, PCB assemblies, and box-build products.

View original content to download multimedia:https://www.prnewswire.com/news-releases/sp-manufacturing-expands-with-new-malaysia-plant-acquires-ideal-jacobs-302338858.html

SOURCE SP Manufacturing

Technology

Casect Launches AI-Enhanced Case Log Platform for Surgeons

Published

5 hours ago

December 25, 2024

SHERIDAN, Wyo., Dec 25, 2024 /PRNewswire/ — Casect, LLC, a medical education technology company, announces the launch of an innovative platform to revolutionize how surgeons and medical professionals document cases. Casect empowers users to track surgical Cases, refine Techniques, organize References, and collaborate with Colleagues — all within a user-friendly, HIPAA-compliant system.

Say goodbye to inefficient notebooks, spreadsheets, and outdated case logs. Casect offers a modern, comprehensive solution tailored to the surgical community, enabling professionals to focus on growth, learning, and excellence in patient care.

A New Era of AI-Powered Case Tracking

Time is critical for surgeons, yet valuable insights are often lost due to outdated documentation methods like handwritten notes or spreadsheets. Casect’s HIPAA-compliant platform, with a no data retention policy for protected health information, uses optional AI to pre-fill case details, analyze uploads, and organize data seamlessly. This transforms hours of documentation into minutes, giving surgeons more time to refine skills and improve patient care.

Casect addresses an unmet need in medical education, residency, fellowship, credentialing, and research. It enables detailed documentation of Cases, Techniques, and References, accessible from any computer or mobile device with a subscription.

Key Features

AI-Assisted Case Entry (Optional): Streamline input with AI or manually add details; supports spreadsheet uploads.Customizable Fields: Track cases your way.Refine Techniques: Create, document, and improve surgical techniques.Multimedia Support: Upload, organize, and access photos, videos, and documents.Organize References: Annotate, markup, and securely store documents and literature.Collaborate Seamlessly: Share cases and techniques effortlessly with colleagues.Analyze and Export: Generate insights through charts or export data as CSV.HIPAA-Compliant: Designed to meet strict HIPAA standards, ensuring the security and confidentiality of protected health information.

Additional Resources

Stay Informed: Unlock a 30-day free trial by signing up for the latest updates on Casect’s launch.Learn More: Discover why Casect is the preferred choice for surgeons at Why Casect?Explore Features: View the Full Feature List.Stay Connected: Follow us on X, Facebook, Instagram, and LinkedIn for updates, tips, and stories. Join the conversation with #MedEd, #CaseLog, and #Casect.

About Casect

Born from decades of tracking cases with stickers, notes, and spreadsheets, Casect empowers surgeons with efficient, comprehensive tools to document cases, collaborate, and drive professional growth. By simplifying the case log, Casect helps surgeons identify trends, enhance skills, and improve patient outcomes. For more information, visit www.casect.com or follow us on X, Facebook, Instagram, and LinkedIn @CasectLLC.

CONTACT: support@casect.com

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SOURCE Casect, LLC