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.AIFounded 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.AIEmail: [email protected] 
 

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

NEW YORK, July 3, 2024 /PRNewswire/ — The embedded security and digital authentication market is primed for strong growth in the coming years, driven by several intensifying factors: increased threats, new regulations, and secure lifecycle management demands. ABI Research, a global technology intelligence firm, expects the embedded secure hardware market to grow 12% between now and 2028 when total shipments will reach almost 8 billion globally.  

“The embedded space is host to a variety of form factor demands that provide for a rich and complex security ecosystem that is constantly evolving. The convergence of the secure element and eSIM space, the hybridization of secure MCUs and MPUs, and the fragmentation of the TEE market all create demand for security stemming from myriad applications and use cases,” says Michela Menting, Senior Research Director at ABI Research.
At the bottom of the stack, simple functionalities for secure storage, secure boot processes or a hardware root of trust can be fulfilled by a secure element. At the other end of the spectrum, complex, multi-application edge devices with embedded operating systems want to protect machine learning algorithms in secure execution environments.  According to Menting, “It is the latter market that will drive the highest revenues. Better virtualization technologies in smaller form factors are enabling parallel secure containerization and enclaves for confidential processing in embedded systems; these capabilities are in high demand for flexible but secure device management.”
From secure integrated circuits to TEE-based microcontrollers, the embedded security market is vibrant and competitive, host to dozens of semiconductors and silicon IP providers. Dominant proprietary solutions are increasingly being challenged by open-source alternatives and technologies that don’t necessarily align with established standards. This fragmentation can sometimes be problematic in terms of security cohesion and interoperability, but it also points to a gap in the market that clearly cannot be fulfilled by the incumbents alone.
“With the growing threat landscape, notably in the IoT space, and increasing policy and regulation pushing for more supply chains and end devices, the outlook for the secure embedded hardware market is highly opportunistic,” Menting concludes.
These findings are from ABI Research’s Digital Authentication and Embedded Security market data report. This report is part of the company’s Trusted Device Solutions research service, which includes research, data, and ABI Insights. 
About ABI Research
ABI Research is a global technology intelligence firm uniquely positioned at the intersection of technology solution providers and end-market companies. We serve as the bridge that seamlessly connects these two segments by providing exclusive research and expert guidance to drive successful technology implementations and deliver strategies proven to attract and retain customers.
ABI Research是一家全球性的技术情报公司，拥有得天独厚的优势，充当终端市场公司和技术解决方案提供商之间的桥梁，通过提供独家研究和专业性指导，推动成功的技术实施和提供经证明可吸引和留住客户的战略，无缝连接这两大主体。
For more information about ABI Research’s services, contact us at +1.516.624.2500 in the Americas, +44.203.326.0140 in Europe, +65.6592.0290 in Asia-Pacific, or visit www.abiresearch.com.
Contact Info: 
Global                                                              Deborah Petrara                                                           Tel: +1.516.624.2558                                                    [email protected]      
Logo – https://mma.prnewswire.com/media/2309035/4794109/ABI_Research_2024.jpg

View original content:https://www.prnewswire.co.uk/news-releases/embedded-security-market-primed-for-strong-growth-with-high-end-edge-devices-driving-the-revenue-opportunity-302188532.html

Passionate Bikers and Tech Experts unite to combine a powerful and compact e-bike system into an ultra-light build, the Amflow PL
FRANKFURT, Germany, July 3, 2024 /PRNewswire/ — Amflow, the eMTB expert that builds e-bikes from heart to body, today marks its entry into the industry with the launch of the Amflow PL. Providing a significantly robust 850 W of peak power and weighing in at an industry leading level of ultra-light 19.2kg1, the Amflow PL provides riders with an unmatched combination of power, range, and performance, hidden in a sleek electric mountain bike appearance.

 
“As engineers with a passion for mountain biking, we have seen a lot of tech innovation that has never found its way into the eMTB scene,” said Peter Archer, Amflow Senior Product Specialist at Amflow. “We have married our tech expertise with our passion and today we’re introducing Amflow to the mountain biking community with our very first product, the Amflow PL. We believe this is a significant moment for the eMTB industry with innovative technology and ultra-light material combining to turn any terrain into a wonderland of possibilities for eMTB riders.”
Ultra-light Frame, Organic Design
The Amflow PL is a full-power eMTB with a stunningly lightweight body. The ultra-light carbon fibre frame weighs just 2.27kg1 and has been designed and expertly-crafted to deliver the ultimate ride, wherever the rider is headed.
Tackle Terrain with Confidence
At the heart of the Amflow PL is the DJI Avinox Drive System incorporating multiple cutting-edge technologies in both software and hardware design. The drive unit features a compound planetary gearset, providing industry-leading power-to-size ratio, with 105 Nm torque and peak power output of 850 W (nominal power output of 250 W) from a drive unit weighing just 2.52kg1.
The high-strength polymer gears inside the drive unit effectively suppress noise during high-speed gearbox operation. With multiple high-precision sensors built-in, combined with DJI’s advanced algorithms, it provides a strong and smooth assistance experience across a wide range of scenarios and conditions.
Preference Matching Assistance
In addition to traditional assistance modes, the DJI Avinox Drive System also features a specialized Auto mode, which adapts assistance in real-time based on road conditions and riding position1.  Once enabled, Auto mode empowers users to tackle a wide variety of terrain types and gradients without having to switch modes.
For the most challenging trails, Boost mode can be activated to instantly receive 120 Nm of torque and 1000 W high-power assistance1, enabling steep inclines to be tackled with ease.
Furthermore, Amflow PL has Walk mode which features intelligent walk assistance for easy incline traversing, Auto Hold to prevent rollback on slopes, and Hill Start Assist for additional torque to get riders started on inclines. It also allows stationary gear-shifting for a smooth and intuitive experience.
Fast Charging, High-Capacity Battery Offers Extended Range
The Avinox system’s battery weighs just 2.87kg1 and boasts an ultra-high energy density, ensuring an uncompromised range.
For those wanting to get back out there as soon as possible, a compact and convenient 12A/508W GaN fast charger1 is capable of charging the battery from 0% to 75% in just 1.5 hours1.
When it comes to battery life; real-time monitoring, self-discharge, active voltage reduction, and abnormality alerts, all feed into the battery health management system to create a durable and reliable battery that still maintains at least 80% capacity after 500 charge-discharge cycles1.
Agile and Responsive with Cutting-edge Geometry
The Amflow PL’s all-around frame design features cutting-edge geometry, offering balanced performance that’s both lightweight and hyper-agile. This stable yet agile handling empowers riders to easily take on rugged trails and more technical rides.
For those looking to adapt the wheel size to their needs, the Amflow PL frame structure is compatible with both 27.5″ and 29″ rear wheels1.  So, whether looking for a smoother ride with larger wheels or agility with smaller ones, a simple adjustment of the flip chip will allow for either size to be fitted without altering the frame’s geometric center of gravity.
Optimized Ride Efficiency
Featuring a four-bar linkage structure, the Amflow PL significantly reduces pedal kickback while greatly improving pedaling efficiency, ensuring that every pedal stroke counts.
Superior Suspension
The rear shock, co-tuned with FOX, offers a sensitive initial stroke response to effectively filter out minor vibrations. It also provides powerful end-stroke support to prevent bottom-outs during continuous high-speed impacts or steep descents, enabling riders to fully enjoy every off-road adventure.
Danny Tien, Asia Sales Manager at FOX said: “FOX has always been dedicated to pursuing better, which mirrors Amflow’s passion to create the ultimate riding experience. During our collaboration process, we were impressed by the enthusiasm and professionalism of the Amflow team. Whether as a business partner or an experienced bike user, we are excited to witness the birth of Amflow PL, an all-round electric mountain bike. The excellent handling experience brought by its ultra-lightweight and cutting-edge design cements our belief that the presence of Amflow will allow more cycling enthusiasts to enjoy the thrill of electric mountain biking.”
 Control at Your Fingertips
At the core of the DJI Avinox system is a 2″ full-color OLED touchscreen control display which is integrated directly into the frame of the Amflow PL. Riders are presented with a wealth of information including real-time riding data, estimated range and the ability to adjust the setup with just a swipe.
Even greater control can be gained by Bluetooth-enabled Wireless Controllers that connect wirelessly to the control display. Mode switches can be made while riding.
When connected to the Avinox App riders have access to;
Customizable Parameters: Parameters of riding modes can be quickly customized to adjust power, torque and cadence, according to riding habits.Anti-theft Mode1: A password-protected anti-theft mode will sound an alarm and the app will send a notification, if unauthorized movement of the eMTB is detected.Remote Locating: The bike’s real-time location can easily be checked.Comprehensive Data Recording, Easy Metric Sharing
With the control display or the Avinox app, riders can review rich data like speeds, range, cadence, power, torque, gradient, altitude, calories burned, ride times, heart rate, and more. This data can also be easily synced with third-party apps such as Strava to share with friends and the eMTB community. 
Thoroughly Tested for Optimum Reliability
Riders of the Amflow PL bike and users of the DJI Avinox Drive System components can be assured of the quality of the products as they have been certified by authoritative organizations such as TÜV SÜD, UL Solutions, and TÜV Rheinland1.
Additionally, Amflow has established a testing platform to conduct a wide variety of reliability tests for frame strength, waterproofing, and long-distance transportation under real-world riding conditions. This ensures product stability and safety in extreme environments, delivering comprehensive quality assurance.
Availability
Amflow products are estimated to be available by Q4 2024 through authorized dealers in Germany, the UK and Australia amongst others. This global service network provides customers with timely, efficient, and professional services, continuously safeguarding product quality.
For more information about Amflow and Amflow PL, please visit: https://www.amflowbikes.com/pl-carbon
About AmflowProudly born in 2023, Amflow is the creation of tech experts with a limitless passion for riding mountain bikes. The company strives to amaze with an unmatched combination of power, range, and performance, hidden in sleek electric mountain bike bodies. Amflow’s commitment to the e-bike industry is to make its e-mountain bikes the go-to for all e-bike riders looking to turn any terrain into a wonderland of possibilities. 
About DJISince 2006, DJI has led the world with civilian drone innovations that have empowered individuals to take flight for the first time, visionaries to turn their imagination into reality, and professionals to transform their work entirely. Today, DJI serves to build a better world by continuously promoting human advancement. With a solution-oriented mindset and genuine curiosity, DJI has expanded its ambitions into areas such as cycling, renewable energy, agriculture, public safety, surveying and mapping, and infrastructure inspection. In every application, DJI products deliver experiences that add value to lives around the world in more profound ways than ever before.
For more information, visit our:Website: https://www.amflowbikes.comFacebook: https://www.facebook.com/amflowbikes/Instagram: https://www.instagram.com/amflowbikesSubscribe to our YouTube Channel: https://www.youtube.com/@amflowbikes
1 All data was tested in controlled conditions. Actual experience may vary. For more details, please refer to the product page on the official Amflow website.
Photo – https://mma.prnewswire.com/media/2450854/image.jpg Photo – https://mma.prnewswire.com/media/2453451/Eurobike.jpg

View original content:https://www.prnewswire.co.uk/news-releases/new-electric-mountain-bike-player-amflow-enters-market-unveiling-its-revolutionary-first-bike-powered-by-dji-avinox-at-eurobike-2024-302188768.html