UKCA

Hyperfine, Inc. Continues Global Market Expansion by Entering Into a Distribution Partnership with Radiosurgery Global, Ltd. to Bring the Swoop® System to India

Retrieved on: 
火曜日, 5月 28, 2024
Health, Technology, Photography, Health Technology, Radiology, Hardware, Partnership, CE, Patient, UKCA, Google Images, Prevalence, Brain, FDA, MRI, Trauma, Stroke, MDR, Certification, Hyperfine structure, Nursing care plan, CDSCO, Medical imaging

The distribution agreement also includes the countries of Malaysia, Indonesia, and Singapore through future expansion, offering Hyperfine, Inc. a significantly increased presence in Asia.

Key Points: 
  • The distribution agreement also includes the countries of Malaysia, Indonesia, and Singapore through future expansion, offering Hyperfine, Inc. a significantly increased presence in Asia.
  • The clinical value of the Swoop® system is applicable globally as Hyperfine, Inc. aims to expand overall access and availability of MRI.
  • The expansion into global markets is supported by the company’s strong track record of securing international approvals for the Swoop® system.
  • Hyperfine, Inc. plans to continue its commercial expansion in partnership with Radiosurgery Global, Ltd. supporting future marketing submissions in India.

Element Science Appoints Lee Smith, Jr. as the Company’s First Head of Commercial

Retrieved on: 
水曜日, 5月 15, 2024
Hardware, Electronic Design Automation, Data Management, Consumer Electronics, Technology, Marketing, Communications, General Health, Medical Devices, Wearables, Mobile Technology, Science, Software, Networks, Research, Health, Mobile, Wireless, Patient, UKCA, Machine learning, Algorithm, FDA, Commercial, European, Sale, PMA, Jewel, Head, Multimedia, Management

Element Science, an innovative health technology company developing a pioneering digital wearable platform for high-risk cardiovascular patients, announced the appointment of Lee Smith Jr. as the company's first Head of Commercial.

Key Points: 
  • Element Science, an innovative health technology company developing a pioneering digital wearable platform for high-risk cardiovascular patients, announced the appointment of Lee Smith Jr. as the company's first Head of Commercial.
  • Mr. Smith's extensive experience, particularly most recently as Head of Commercial of Philips’ Ambulatory and Diagnostic Monitoring Group, will shape Element Science's strategic approach to commercialization.
  • "We are thrilled to welcome Lee Smith Jr. to our leadership team as our first Head of Commercial," said Dr. Uday N. Kumar, Founder, President & CEO of Element Science.
  • "I'm very excited to join Element Science and contribute to the successful launch of the Jewel P-WCD," said Mr. Smith.

Owlet Announces UK Medical Certification of Dream Sock®

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火曜日, 5月 14, 2024
Software, Specialty, Consumer Electronics, Consumer, Apps, Applications, Technology, Medical Devices, Health Technology, Parenting, Retail, Children, Baby, Maternity, Health, Infant, Base station, Parent, UKCA, Babysitting, Sleep, Food, Diagnosis, Foot, Certification, Caregiver, OWLT, CE marking

Owlet , Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer of smart infant monitoring, has received UK medical device certification, following the recent achievement of CE Mark certification.

Key Points: 
  • Owlet , Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer of smart infant monitoring, has received UK medical device certification, following the recent achievement of CE Mark certification.
  • The UKCA certification, granted by a recognized UK-approved body, follows the recent announcement of Owlet’s EU CE mark certification of Dream Sock earlier this month and now provides Owlet with medical device certifications in key UK and European markets where its distribution partners operate.
  • “Owlet is extremely well-positioned to take advantage of both the UKCA and EU medical certifications with key retail partnerships across the European market.
  • Dream Sock, as certified for the UK, is intended for use with healthy infants between 0-18 months and 2.5-13.6 kg.

Hyperfine, Inc. to Expand Global Market Reach with Appointment of International Distributors in Key European Markets

Retrieved on: 
金曜日, 5月 10, 2024
Software, Radiology, Hardware, Health, Artificial Intelligence, Medical Devices, Health Technology, Technology, CE, Patient, UKCA, Hospital, International business, FDA, Commercial, Boston Scientific, MDR, Certification, Stroke, Nursing care plan

The system the company is introducing to the European markets is commercialized in the U.S. and is the highest performing Swoop® system to date in terms of image quality and usability.

Key Points: 
  • The system the company is introducing to the European markets is commercialized in the U.S. and is the highest performing Swoop® system to date in terms of image quality and usability.
  • Introducing the Swoop® system into international markets is a significant step in supporting the commercial growth of Hyperfine, Inc.
  • The Swoop® system can expand the existing imaging market with its transformative, affordable, and accessible platform to serve more clinicians and patients needing brain imaging.
  • “There is a growing global demand for accessible MR brain imaging, which the versatile Swoop® system can meet.

Meditrina Announces CE Mark Approval and First Multi-International Cases Performed

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火曜日, 5月 14, 2024
Health care, UKCA, Diagnosis, Safety, Hysteroscopy, Health, SAN, Uterus, Senior, Regulation, Growth, Woman, Aveta, CE marking, European, Medical device

SAN JOSE, Calif., May 13, 2024 /PRNewswire/ -- Meditrina, a leading innovator in gynecologic medical devices, announces the successful receipt of UKCA Mark, and CE Mark approval in accordance with Regulation (EU) 20147/745, for its state-of-the-art Aveta Hysteroscopy System.

Key Points: 
  • SAN JOSE, Calif., May 13, 2024 /PRNewswire/ -- Meditrina, a leading innovator in gynecologic medical devices, announces the successful receipt of UKCA Mark, and CE Mark approval in accordance with Regulation (EU) 20147/745, for its state-of-the-art Aveta Hysteroscopy System.
  • Receiving the UKCA and CE Mark approval underscores Meditrina's dedication to meeting the highest standards of quality, safety, and efficacy required for market entry in the European Union and the UK.
  • This achievement not only validates the company's commitment to regulatory compliance but also positions Meditrina as a trusted provider of cutting-edge medical solutions.
  • "We are excited to receive UKCA and CE Mark approval for our hysteroscopy system, as it validates the exceptional quality and performance of our product," remarked Csaba Truckai, CEO of Meditrina.

Balluff Adds Next-Level Capabilities to Code Reader With IO-Link

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金曜日, 4月 12, 2024
IP67, IDENT, IO-Link, Humidity, Ethernet, IP, Web browser, WEEE, FCC, API, REST, Food, Vibration, MQTT, 2D, UKCA, CE, Video game

FLORENCE, Ky., April 12, 2024 /PRNewswire-PRWeb/ -- A firmware update delivers next-level capabilities to Balluff's code reader with IO-Link.

Key Points: 
  • Firmware Update Make Optical Code Reader an Easy Choice to Replace Legacy Cameras, Code Readers
    FLORENCE, Ky., April 12, 2024 /PRNewswire-PRWeb/ -- A firmware update delivers next-level capabilities to Balluff's code reader with IO-Link.
  • The inclusion of IO-Link allows users to integrate code reading without adding separate Ethernet drops and IP addresses for every reader.
  • These stationary sensors use the MVTec HALCON algorithm, with integrated code quality metrics that allow it to provide a code quality grade in addition to the code data.
  • The firmware update for this vision-based code reader helps it deliver next-level capabilities for the future of manufacturing.

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

Retrieved on: 
木曜日, 3月 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

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木曜日, 4月 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: 
木曜日, 2月 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: 
木曜日, 2月 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.