UKCA

Hyperfine, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
Research, SAFE, Growth, HOPE, CE, Patient, PMR, ACTION, UKCA, Hydrocephalus, ECMO, News, MDR, Pediatrics, Malnutrition, Nursing care plan, Marketing, FDA, Video game

Revenues for the fourth quarter of 2023 were $2.69 million, up 89%, compared to $1.42 million in the fourth quarter of 2022.

Key Points: 
  • Revenues for the fourth quarter of 2023 were $2.69 million, up 89%, compared to $1.42 million in the fourth quarter of 2022.
  • Gross margin for the fourth quarter of 2023 was $1.03 million, compared to $0.30 million in the fourth quarter of 2022.
  • Research and development expenses for the fourth quarter of 2023 were $5.96 million, compared to $5.22 million in the fourth quarter of 2022.
  • Sales, marketing, general, and administrative expenses for the fourth quarter of 2023 were $6.70 million, compared to $8.71 million in the fourth quarter of 2022.

Ezurio Announces the Sona™ MT320: The First Industrial Grade Wi-Fi 6 + Bluetooth Module Powered by MediaTek Filogic 320 Technology

Retrieved on: 
Thursday, April 4, 2024
Sona, OS, FCC, Certification, MediaTek, CE, Bed, SDIO, Wi-Fi, Partnership, Internet of things, Tungsten, UKCA, Linux, SMARC, SMT, Wi-Fi 6, WPA3, HD, Pump, Bluetooth Special Interest Group, Bluetooth, Mobile phone

AKRON, Ohio, April 4, 2024 /PRNewswire/ -- Ezurio, a global leader in connectivity, today announces the upcoming Sona™ MT320 , the latest addition to their growing Wi-Fi 6 module portfolio.

Key Points: 
  • AKRON, Ohio, April 4, 2024 /PRNewswire/ -- Ezurio, a global leader in connectivity, today announces the upcoming Sona™ MT320 , the latest addition to their growing Wi-Fi 6 module portfolio.
  • The Sona MT320 is the first industrial grade Wi-Fi + Bluetooth module based on the segment leading MediaTek Filogic 320 (MT7921) Wi-Fi 6 chipset.
  • This embedded module series has been designed to work seamlessly with the MediaTek Genio processor family targeted at the industrial IoT sector.
  • The Sona MT320 provides a rugged, compact, and globally certified solution that ensures reliable connectivity and easy integration.

Spectral AI Appoints Peter M. Carlson as CEO

Retrieved on: 
Thursday, February 29, 2024
Momentum, CFO, UKCA, Burn, Artificial intelligence, MiMedx, Spectral, FDA, Growth, MDAI, Brings, Highlight, Senior advisor, Classification, Burns, DFU, Corporation

DALLAS, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that its Board of Directors (the “Board”) has appointed Peter M. Carlson, Spectral AI’s current Chief Financial Officer, as Chief Executive Officer and a member of the Board. He succeeds Wensheng Fan, who, after 14 years with Spectral AI, including nearly four as CEO, is transitioning to Chief Innovation Strategist and Senior Advisor to the CEO. Vincent S. Capone, Spectral AI’s General Counsel and Corporate Secretary, will assume the additional role of Chief Financial Officer.

Key Points: 
  • He succeeds Wensheng Fan, who, after 14 years with Spectral AI, including nearly four as CEO, is transitioning to Chief Innovation Strategist and Senior Advisor to the CEO.
  • Vincent S. Capone, Spectral AI’s General Counsel and Corporate Secretary, will assume the additional role of Chief Financial Officer.
  • He joined Spectral AI as CFO in January 2024 following the Company’s debut on the NASDAQ Global Market.
  • “In his short time here, Pete has already distinguished himself as a skilled and experienced leader and a tremendous asset to Spectral AI.

Spectral Receives UKCA Authorization for Burn Indication Expected Commercialization 2nd Half 2024

Retrieved on: 
Thursday, February 22, 2024
UKCA, Algorithm, Burn, Artificial intelligence, Spectral, MDAI, Sale, Surgeon, Government, Observation, Ageing, Nursing

"I am delighted to announce this achievement in our Company’s evolution.

Key Points: 
  • "I am delighted to announce this achievement in our Company’s evolution.
  • “In addition, this regulatory authorization opens up the ability to expand partnerships with regions such as the Middle East that recognize the UKCA authorization.”   Revenue from commercialization in the UK in 2024 represents an addition to the $28 million revenue guidance previously communicated by the Company.
  • “This protracted decision process burdens the patient as well as the healthcare system with unnecessary hospitalization time.
  • The Company aims to extend its technology to benefit pediatric populations and is continuing to initiate case studies and case series with surgeons at leading burn centers.

Spectral AI Announces Publication of Letter to Shareholders

Retrieved on: 
Monday, February 5, 2024
DFU, Diabetic foot ulcer, MDAI, Burn, FDA, Artificial intelligence, Trial of the century, UKCA, Wound healing, Letter, Medical device

DALLAS, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the publication of a Letter to Shareholders from the Company’s CEO and Co-founder, Wensheng Fan, and Chairman of the Board, Richard Cotton.

Key Points: 
  • DALLAS, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the publication of a Letter to Shareholders from the Company’s CEO and Co-founder, Wensheng Fan, and Chairman of the Board, Richard Cotton.
  • The Letter to Shareholders addresses the Company’s progress along multiple fronts as it continues to evolve from a late-stage development company towards commercialization of its AI-driven DeepView System.
  • The Company believes that this proprietary platform technology can revolutionize the standard of care in wound assessment and treatment for burn and Diabetic Foot Ulcer (“DFU”) indications.
  • Highlights of the Letter to Shareholder include:
    The largest contract in the Company’s history, a $149 million award from BARDA that provides non-dilutive funding for ongoing product development and procurement.

Toku Obtains CE and UKCA Marks for AI Cardiovascular Risk Assessments Through the Eye

Retrieved on: 
Monday, February 5, 2024
Cardiology, Biotechnology, Optical, General Health, Health, Artificial Intelligence, Medical Devices, Technology, Multimedia, Intelligence, CVD, University College London, History, Cardiovascular disease, Patient, Safety, Splenic infarction, Kidney, Stroke, Temperature, Retina, Pharmacy, Gold, Heart rate, Quality of life, UKCA, Risk, CE, Eye, Blood pressure, Medical device

Toku, Inc., a commercial medical device company specializing in AI assessment of retinal images, announced today that it has obtained CE and UKCA Marks for its patented CLAiR technology.

Key Points: 
  • Toku, Inc., a commercial medical device company specializing in AI assessment of retinal images, announced today that it has obtained CE and UKCA Marks for its patented CLAiR technology.
  • The CLAiR technology integrates readily with existing retinal cameras, to provide real-time CVD risk assessments with accuracy comparable to gold standard cardiovascular risk assessments (which typically require blood tests and can take weeks).
  • The AI-powered CLAiR technology identifies elevated cardiovascular risk by analyzing minute changes in the retina and its vasculature.
  • CLAiR will enable healthcare providers in various settings to identify elevated cardiovascular risk in adult patients with no known history of cardiovascular disease.

Spectral Submits Application for UKCA Mark Classification

Retrieved on: 
Monday, January 29, 2024
Ageing, Artificial intelligence, Patient, Burn, MDAI, UKCA, Government, NASD, Spectral, Physician, Surgeon, Hearing, Medical device

The predictive software DeepView AI®-Burn seamlessly integrates with our UKCA granted application for our imaging device, DeepViewSnapShot.® The DeepView System processes the image and displays the original wound, while highlighting the nonhealing parts of the burn, defined as deep 2nd and 3rd degree burns.

Key Points: 
  • The predictive software DeepView AI®-Burn seamlessly integrates with our UKCA granted application for our imaging device, DeepViewSnapShot.® The DeepView System processes the image and displays the original wound, while highlighting the nonhealing parts of the burn, defined as deep 2nd and 3rd degree burns.
  • This diagnostic predictive analysis is delivered within seconds and aids physicians in making an informed decision on patient treatment protocols.
  • UKCA marking is a product certification system established by the UK government to ensure that products sold in the UK market (England, Wales, and Scotland) comply with relevant laws and technical standards.
  • The DeepView AI®-Burn indication is for individuals aged eighteen years and older.

Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator

Retrieved on: 
Thursday, January 25, 2024
Health, Medical Devices, Technology, Health Technology, Other Health, Wearables, Mobile Technology, Cardiology, BSI, Death, Patient, MDR, SCA, BSI Group, American Heart, Jewel, Multimedia, Survival, Miniaturization, UKCA, Science, European, Algorithm, Sale, Arrest, Arrhythmia, CE marking, Boston Scientific, Machine learning, CE, Medical device

View the full release here: https://www.businesswire.com/news/home/20240125437671/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240125437671/en/
    Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator First of its kind life-saving technology receives CE Mark and UKCA Mark, paving the way for enhanced protection of patients with elevated risk of sudden cardiac arrest.
  • (Photo: Business Wire)
    The Jewel P-WCD was designed to address limitations with traditional garment-based WCDs.
  • The company is now well positioned to plan for delivering this lifesaving technology to patients outside the US."
  • The Jewel P-WCD is limited to investigational use only and is not available for sale in the United States.

Hyperfine, Inc. Launches AI-powered Brain Imaging Software for Enhanced Image Quality and Ease of Use

Retrieved on: 
Tuesday, January 9, 2024
Technology, Medical Devices, Neurology, Health Technology, Software, Biotechnology, Radiology, Health, Artificial Intelligence, DWI, Hospital, Neuroradiology, Multimedia, Hyperfine structure, Food and Drug Administration, UKCA, AI, Workflow, Food, Acquisition, FDA, CE, Medical imaging

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop® system—today announced the launch of the AI-powered eighth generation of Swoop® system software.

Key Points: 
  • Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop® system—today announced the launch of the AI-powered eighth generation of Swoop® system software.
  • The latest software improves Swoop® system image quality and introduces valuable ease-of-use features, including a real-time aid for more precise patient loading and positioning and a streamlined image upload process.
  • Hyperfine, Inc. will roll out software updates for the Swoop® system to users in the coming weeks.
  • For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io .

Spectral AI to Participate in Benchmark’s 12th Annual Discovery One-on-One Conference

Retrieved on: 
Thursday, November 30, 2023
Conference, MDAI, Government, FDA, Burn, CE, UKCA, Ulcer, 3D, DFU, Spectral, Artificial intelligence, Burns, Patient, Algorithm, History, Medical device

DALLAS, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in clinical wound care, today announced that it will participate in the Benchmark 12th Annual Discovery One-on-One Conference being held on December 7, 2023 in New York City.

Key Points: 
  • DALLAS, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in clinical wound care, today announced that it will participate in the Benchmark 12th Annual Discovery One-on-One Conference being held on December 7, 2023 in New York City.
  • Management will participate in 1x1 meetings throughout the day with institutional investors.
  • For more information on the Benchmark 12th Annual Discovery One-on-One Conference, or to schedule a one-on-one meeting, please contact your Benchmark representative or visit the Conference Website: Click here .
  • Together with previous contracts, this brings total U.S. Government awards to the Company since 2019 to more than $246.0 million.