IDE

CroíValve Announces FDA IDE Approval and Initiation of its Early Feasibility Study

Retrieved on: 
Thursday, January 25, 2024
Science, Cardiology, Biotechnology, Research, Health, FDA, Medical Devices, Clinical Trials, IDE, Patient, EFS, Heart, MD, Multimedia, University Medical Center, Tricuspid regurgitation, Surgeon, Tricuspid valve, Quality of life, TCT, CMS, Safety, CICC, Physician, CRF, Human, DUO, Blood, Pharmaceutical industry

CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study (EFS) for the DUO™ Tricuspid Coaptation Valve System, following FDA IDE and CMS approval.

Key Points: 
  • CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study (EFS) for the DUO™ Tricuspid Coaptation Valve System, following FDA IDE and CMS approval.
  • The device is delivered using percutaneous techniques and is secured using a novel anchor system which leaves the right heart and native valve apparatus untouched.
  • The TANDEM II feasibility study will further develop the clinical validation of this novel technology.
  • "We are delighted to initiate TANDEM II, with strong interest in participation in the study from leading U.S. centers.

Swimm Launches World's Most Advanced Contextualized Coding Assistant for Accurate and Instant Code Knowledge

Retrieved on: 
Wednesday, January 17, 2024
IDE, Insight Partners, Microsoft, Documentation, Name, AI, Duet, Software, TEL, First officer (aviation), Online shopping

TEL AVIV, Israel, Jan. 17, 2024  /PRNewswire/ -- Swimm, the leading GenAI-powered coding assistant for contextualized code understanding, today announced the launch of /ask Swimm, the most comprehensive solution available for enterprise software development teams that combines an AI-powered chat and human input to provide personalized and accurate code knowledge instantly. 

Key Points: 
  • TEL AVIV, Israel, Jan. 17, 2024 /PRNewswire/ -- Swimm , the leading GenAI-powered coding assistant for contextualized code understanding, today announced the launch of /ask Swimm, the most comprehensive solution available for enterprise software development teams that combines an AI-powered chat and human input to provide personalized and accurate code knowledge instantly.
  • /ask Swimm is an AI-powered coding assistant providing developers with a multilayered contextual understanding of code, enabling them to significantly boost productivity across the entire development lifecycle.
  • "If large language models can suggest helpful code, shouldn't Swimm be able to leverage LLMs to suggest helpful code documentation?
  • Shouldn't the code documentation captured in Swimm be able to improve future code suggestions and help answer software engineering questions about legacy code?

First Patient Enrolled in Merit Medical’s MOTION Study

Retrieved on: 
Tuesday, January 16, 2024
Injection, IDE, Osteoarthritis, Patient, Risk, Hypervascularity, Evidence-based medicine, MD, Knee, Incidence, Microparticle, FDA, Pain, Inflammation, Blood, MMSI, GAE, Prevalence, Pharmaceutical industry

Under this designation, Embosphere Microspheres received priority review by the FDA, which allowed for accelerated review and development of the MOTION study protocol.

Key Points: 
  • Under this designation, Embosphere Microspheres received priority review by the FDA, which allowed for accelerated review and development of the MOTION study protocol.
  • In conducting the study, Merit intends to randomize patients 1:1 to receive either GAE using Embosphere Microspheres or intra-articular corticosteroid injections.
  • The study is structured to evaluate primary safety and effectiveness of Embosphere Microspheres at 6 months with continued patient follow up through 24 months.
  • “The commencement of this randomized controlled study is a testament to our commitment to evidence-based medicine and patient-centric care,” said Sandeep Bagla, MD, Co-Global Principal Investigator of the MOTION study.

BrioHealth Solutions Launches New Corporate Identity and Prepares for Groundbreaking INNOVATE Trial for Advanced Heart Failure Treatment

Retrieved on: 
Thursday, January 11, 2024
Senior, IDE, Patient, Statistics, FDA, Doctor of Philosophy, Treatment

We are excited to be preparing for the initiation of our INNOVATE Trial with the BrioVAD™ System."

Key Points: 
  • We are excited to be preparing for the initiation of our INNOVATE Trial with the BrioVAD™ System."
  • Headquartered in Burlington, Massachusetts, BrioHealth Solutions is expanding its US organization to meet the challenges of developing and introducing innovative technologies for advanced heart failure patients.
  • There are a large number of unidentified and untreated advanced heart failure patients, and the limited number of donor organs cannot address all of them.
  • We believe BrioHealth Solutions and the BrioVAD™ System will play an essential role in helping these patients and their families."

Endovascular Engineering's Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

Retrieved on: 
Thursday, January 11, 2024
IDE, Coronary thrombosis, Patient, Cardiac catheterization, University, Interventional cardiology, Safety, VTE, MPH, Piedmont Hospital, Pulmonary embolism, Pharmaceutical industry

The approval of the IDE follows the successful completion of the company's 25-patient feasibility study.

Key Points: 
  • The approval of the IDE follows the successful completion of the company's 25-patient feasibility study.
  • "We are excited to be at the forefront of this innovative procedure with the completion of the ENGULF feasibility study.
  • This significant achievement sets the stage for definitive results in the ENGULF pivotal trial.
  • Embarking on our ENGULF pivotal trial is a significant step, further validating the system's safety and efficacy.

3Spine Announces Completion of FDA Clinical Trial Enrollment Achieving 325 Surgeries in 2023

Retrieved on: 
Wednesday, January 10, 2024
Titanium, IDE, Spinal fusion, Patient, Research, Principal, Cobalt-chrome, Learning, University Challenge 2013–14, Laminectomy, Friends, Rotation, Medicine, American Medical Association, Back pain, NYU, CPT, Synovial joint, FDA, Clinical trial, Decompression, Contra, Pharmaceutical industry

The company enrolled a larger fusion cohort in an adaptive statistical design to improve propensity score matching between data sets.

Key Points: 
  • The company enrolled a larger fusion cohort in an adaptive statistical design to improve propensity score matching between data sets.
  • The trials involved patients experiencing chronic leg and back pain ranging in age from 23 to 79 across 14 U.S. states.
  • 3Spine plans to seek FDA approval through the Premarket Approval pathway.
  • Information on the real-world fusion clinical trial is available at NCT04823858 .

AcelRx Announces Rebranding With Name Change to Talphera, Inc.

Retrieved on: 
Tuesday, January 9, 2024
IDE, Dialysis, Patient, Hemofiltration, Talisman, SAN, Risk, Heparin, IRB, FDA, Renal replacement therapy, Bleeding, Pain, PMA, Pharmaceutical industry

SAN MATEO, Calif., Jan. 9, 2024 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the rebranding of the Company, with a name change to Talphera, Inc. ("Talphera"). The rebrand decision was made to reflect the Company's strategy of developing and commercializing products to support advancing care to optimize outcomes in medically supervised settings, moving beyond the original focus on acute pain.  The Company's lead nafamostat product candidate, Niyad, is expected to have a Premarket Approval (PMA) submission to the FDA in the second half of 2024.  

Key Points: 
  • The name Talphera was derived from "Talisman", meaning a strong leader, and reflects the new "pharmaceutical era" for the Company.
  • The company's new mission at Talphera is to support healthcare providers by developing and commercializing products in medically supervised settings that deliver advances in care to patients.
  • Talphera will commence trading on the Nasdaq Global Market under the ticker symbol "TLPH" effective January 10, 2024.
  • A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024.

Doosan Robotics Unveils Cutting-Edge Innovations at CES 2024, Paving the Way for the Democratization of Robots

Retrieved on: 
Tuesday, January 9, 2024
Architecture, Microsoft, Ecosystem, Deep learning, Robotics, Sorter, Code, AIV, Human, ChatGPT, AI, SW, IDE, Las Vegas Convention Center, Safety, CES, CTA, Creativity, Environment, Medical device

LAS VEGAS, Jan. 8, 2024 /PRNewswire/ -- Doosan Robotics Inc., one of the world's leading collaborative robot (cobot) manufacturers, is set to revolutionize the robotics industry at CES® 2024 in its unveiling of cutting-edge cobots and AI technologies under the cohesive theme: Think. Sync. Link. Doosan Robotics is exhibiting between January 9-12 at West Hall - Booth 5941 at the Las Vegas Convention Center.

Key Points: 
  • Doosan Robotics is exhibiting between January 9-12 at West Hall - Booth 5941 at the Las Vegas Convention Center.
  • Earlier today, Doosan Robotics presented at its first-ever CES media day, signifying a future where AI empowers cobots to be in perfect sync with humans, seamlessly integrating a cohesive, safe and innovative ecosystem.
  • Driving Doosan Robotics' versatility within the robotics field is its introduction of Dart-Suite , a next generation robot ecosystem redefining the robot experience.
  • Doosan Robotics is showcasing within Doosan Group's exhibit located in the West Hall - Booth 5941 at the Las Vegas Convention Center from January 9-12, 2024.

BlackBerry QNX Announces General Availability of QNX SDP 8.0, its Scalable, High-Performance Foundation for Next Generation Automotive and IoT Systems

Retrieved on: 
Monday, January 8, 2024
Eclipse, Tao, QNX, Senior, Microsoft, Deployment environment, API, BlackBerry, Visual Studio Code, Unix, SDP, IDE, LAS, POSIX, CPU, Engineering, ARM, Safety, TSX, Software design, CES, OS, GCC, Head, BlackBerry Limited, Video game

LAS VEGAS, Jan. 8, 2024 /PRNewswire/ -- CES -- BlackBerry Limited (NYSE: BB; TSX: BB) today announced general availability of its new QNX® Software Development Platform (SDP) 8.0. Combined with the next generation QNX® OS 8.0, the platform delivers a scalable, high-performance real-time operating system available for today's embedded computing industry.

Key Points: 
  • Combined with the next generation QNX® OS 8.0, the platform delivers a scalable, high-performance real-time operating system available for today's embedded computing industry.
  • The fifth generation QNX SDP 8.0 architecture builds on decades of development and a field-proven safe and secure platform, while maintaining its POSIX API to provide an instantly productive environment for both QNX® and Linux® developers.
  • QNX SDP 8.0 lays the foundation for the entire line of next generation BlackBerry® QNX® portfolio products, including QNX® OS for Safety, QNX® Hypervisor and QNX® Hypervisor for Safety.
  • To learn more about BlackBerry QNX, please visit BlackBerry.QNX.com .

Nuvoton Unveils New Production-Ready Endpoint AI Platform for Machine Learning

Retrieved on: 
Friday, January 5, 2024
Ethos, Cortex, MAC, Arm, Agriculture, Telecommunications, DSP, HMI, Health, AI accelerator, Education, FPU, Nervous system, Project Jupyter, AI, Ecosystem, MCU, IDE, Sport, MB, NPU, Machine learning, TensorFlow, MPU, Silicon, Hertz, Medical device

HSINCHU, Jan. 5, 2024 /PRNewswire/ -- Nuvoton is pleased to announce its new Endpoint AI Platform to accelerate the development of fully-featured microcontroller (MCU) AI products. These solutions are enabled by Nuvoton's powerful new MCU and MPU silicon, including the NuMicro® M55M1 equipped with Ethos U55 NPU, NuMicro® MA35D1, and NuMicro® M467 series. These MCUs are a valuable addition to the modern AI-centric computing toolkit and demonstrate how Nuvoton continues to work closely with Arm and other companies to develop a user-friendly and complete Endpoint AI Ecosystem.

Key Points: 
  • HSINCHU, Jan. 5, 2024 /PRNewswire/ -- Nuvoton is pleased to announce its new Endpoint AI Platform to accelerate the development of fully-featured microcontroller (MCU) AI products.
  • Development on these platforms is made easy by Nuvoton's NuEdgeWise: a well-rounded, simple-to-adopt tool for machine learning (ML) development, which is nonetheless suitable for cutting-edge tasks.
  • Together, this powerful core hardware, combined with unique rich development tools, cements Nuvoton's reputation as a leading microcontroller platform provider.
  • NuEdgeWise leverages the popular Jupyter Notebook platform, allowing developers to train and deploy models on Nuvoton chips using TensorFlow Lite.