IDE

AveriSource Launches New AI-Powered Platform and User Experience for Application Modernization

Retrieved on: 
Wednesday, January 31, 2024

DALLAS, Jan. 31, 2024 /PRNewswire/ -- AveriSource, the leading global software provider of AI-powered, data-driven application modernization, announced today that it has completed a major release of its application analysis and modernization solution. The unveiling of AveriSource Platform™ 2.0 marks a pivotal step in the company's strategic growth plan and its innovative, AI-powered product roadmap. This launch follows a significant investment in its go-to-market and sales capabilities with the recruitment of industry veterans Ed Airey as VP of Marketing and Emmett Hynous as VP of Global Sales.

Key Points: 
  • The AveriSource Platform 2.0 release delivers a new user experience for enterprises planning or accelerating their modernization strategy—on the mainframe or in the cloud.
  • Visually engaging and highly interactive dashboards, alongside in-depth reporting and analytics, deliver an intelligent and guided user experience throughout all phases of the application modernization journey.
  • "I'm pleased to announce the general availability of AveriSource Platform 2.0," says David Gutzman, CEO and Managing Partner at AveriSource.
  • The 2.0 release of the AveriSource Platform includes the following application modernization packages: AveriSource Scan, AveriSource Inventory, AveriSource Discover, AveriSource Analyze and AveriSource Transform™.

AveriSource Launches New AI-Powered Platform and User Experience for Application Modernization

Retrieved on: 
Wednesday, January 31, 2024

DALLAS, Jan. 31, 2024 /PRNewswire/ -- AveriSource, the leading global software provider of AI-powered, data-driven application modernization, announced today that it has completed a major release of its application analysis and modernization solution. The unveiling of AveriSource Platform™ 2.0 marks a pivotal step in the company's strategic growth plan and its innovative, AI-powered product roadmap. This launch follows a significant investment in its go-to-market and sales capabilities with the recruitment of industry veterans Ed Airey as VP of Marketing and Emmett Hynous as VP of Global Sales.

Key Points: 
  • The AveriSource Platform 2.0 release delivers a new user experience for enterprises planning or accelerating their modernization strategy—on the mainframe or in the cloud.
  • Visually engaging and highly interactive dashboards, alongside in-depth reporting and analytics, deliver an intelligent and guided user experience throughout all phases of the application modernization journey.
  • "I'm pleased to announce the general availability of AveriSource Platform 2.0," says David Gutzman, CEO and Managing Partner at AveriSource.
  • The 2.0 release of the AveriSource Platform includes the following application modernization packages: AveriSource Scan, AveriSource Inventory, AveriSource Discover, AveriSource Analyze and AveriSource Transform™.

The Next Evolutionary Step in Customizable Logic, Microchip Releases PIC16F13145 Family of MCUs

Retrieved on: 
Wednesday, January 24, 2024

Outfitted with a new Core Independent Peripheral (CIP)—the Configurable Logic Block (CLB) module—the MCUs enable the creation of hardware-based, custom combinational logic functions directly within the MCU.

Key Points: 
  • Outfitted with a new Core Independent Peripheral (CIP)—the Configurable Logic Block (CLB) module—the MCUs enable the creation of hardware-based, custom combinational logic functions directly within the MCU.
  • The process is further simplified by a graphical interface tool, which helps synthesize custom logic designs using the CLB.
  • The PIC16F13145 family is designed for applications utilizing custom protocols, task sequencing or I/O control to manage real-time control systems in the industrial and automotive sectors.
  • For additional information and to purchase, contact a Microchip sales representative, authorized worldwide distributor or visit Microchip’s Purchasing and Client Services website, www.microchipdirect.com .

Microbot Medical Expands US Clinical Infrastructure in Support of the Upcoming IDE Submission to Commence its First in Human Clinical Study

Retrieved on: 
Thursday, January 18, 2024

BRAINTREE, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that following the recent positive results of its pivotal GLP Pre-Clinical Study, and to support its anticipated IDE submission to commence its first in human clinical trial, the Company added a US- based Clinical Research Associate (CRA).

Key Points: 
  • BRAINTREE, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that following the recent positive results of its pivotal GLP Pre-Clinical Study, and to support its anticipated IDE submission to commence its first in human clinical trial, the Company added a US- based Clinical Research Associate (CRA).
  • The CRA will join the already established clinical team in the USA, led by Dr. Juan Diaz-Cartelle, the Company’s Chief Medical Officer.
  • "Following the successful completion of our pivotal GLP pre-clinical trial, and as we are in the final stage of submitting our IDE, having an in house CRA is a key piece for establishing the right infrastructure for clinical trial execution" said Dr. Diaz-Cartelle, Chief Medical Officer.

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

Retrieved on: 
Thursday, January 25, 2024

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

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

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

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

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

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 .