ISRAEL

DGAP-News: Pi-Cardia Receives FDA IDE Approval for Pivotal Study with ShortCut(TM) Device

Retrieved on: 
Tuesday, July 26, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Investigational device exemption, Time, TAVR, Food, ISRAEL, Aortic stenosis, Heart, Intention, Percutaneous aortic valve replacement, Risk, University Medical Center, Premolar, Safety, Structural heart disease, FDA, MD, Patient, Hemodynamics, IDE, Growth, Medical device

REHOVOT, ISRAEL / ACCESSWIRE / July 26, 2022 / Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to commence the ShortCut Pivotal Study, which will assess the safety and effectiveness of the ShortCut device.

Key Points: 
  • REHOVOT, ISRAEL / ACCESSWIRE / July 26, 2022 / Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to commence the ShortCut Pivotal Study, which will assess the safety and effectiveness of the ShortCut device.
  • The TAVR market, currently estimated at $6 billion, is projected to double over the next five years, with the expansion into low-risk younger patients.
  • Pi-Cardia's Leaflex device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics.
  • The ShortCut device and Leaflex device are investigational devices, limited by United States law for investigational use.

DGAP-News: Tracxpoint, LLC: Elevating a ‘Simple’ Shopping Cart Security Lock with the Power of Artificial Intelligence

Retrieved on: 
Tuesday, July 19, 2022
Housing, Television, Leadership, R, ISRAEL, Engineer, Intelligent system, Theft, QR code, Smarte Carte, Indoor positioning system, Eye, Mozilla Location Service, Data, Heat, Supermarket, Amusement park, Online shopping

Tracxpoint transforms a simple cart locking device, into a Powerful, Intelligent System, with Data Connectivity, Location Services, Personalization and more.

Key Points: 
  • Tracxpoint transforms a simple cart locking device, into a Powerful, Intelligent System, with Data Connectivity, Location Services, Personalization and more.
  • "With the rollout of our Daivi Smart Cart and CHECXiN Cart Management products, we received many inquiries from budget-conscious grocers about the possibility of getting their feet wet' with a less robust solution.
  • Several retailers were already using coin-operated locks, so our Engineers decided to re-imagine' this type of security device to connect with our AI-Driven ecosystem."
  • "TLoc may appear as a simple chain-locking mechanism, but the data and insight it provides to store operators is exceptionally valuable and unmatched."

Pi-Cardia ShortCut(TM) Device Successfully Treats First Patients in Europe

Retrieved on: 
Monday, December 20, 2021
Calcification, Clinical trial, Physician, Hemodynamics, Aortic stenosis, Growth, Percutaneous aortic valve replacement, Risk, Patient, Shortcut, Universities and research institutions in Berlin, ISRAEL, Heart, TAVR, Medical device

"We were able to successfully treat three patients with degenerated valves who were at risk of coronary obstruction after TAVR with the ShortCut(TM) device," said Prof. Kempfert.

Key Points: 
  • "We were able to successfully treat three patients with degenerated valves who were at risk of coronary obstruction after TAVR with the ShortCut(TM) device," said Prof. Kempfert.
  • ShortCut(TM) is part of Pi-Cardia's product portfolio, which also includes the Leaflex(TM) device - a standalone, non-implant-based treatment for patients with aortic stenosis.
  • "As the number of patients with aortic stenosis continues to grow, both Shortcut(TM) and Leaflex(TM) may offer important new treatment options for both physicians and patients."
  • The Leaflex(TM) device is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis.

DGAP-News: ASTERRA Releases EarthWorks Rail to Positively Impact Serviceability of Railway Tracks

Retrieved on: 
Monday, November 29, 2021
Sustainable Development Goals, Earthworks, Technology, Industry, Plan, ISRAEL, Transport, Business development, Forest, Goal, Pandanus utilis, Artificial intelligence, Chicago Innovation Awards, Climate change, TEL, United Nations, SAR, Government, Mining, MWH, Failure, Intelligence, Nightclub, Renewable energy, Civil engineering

TEL AVIV, ISRAEL / ACCESSWIRE / November 26, 2021 / New EarthWorks technology by ASTERRA will be featured at Rail Live!

Key Points: 
  • TEL AVIV, ISRAEL / ACCESSWIRE / November 26, 2021 / New EarthWorks technology by ASTERRA will be featured at Rail Live!
  • ASTERRA is slated to present the first innovation pitch at the event, called, "Where will the next slope failure hit?"
  • will also hold a round table discussion on the subject, "How does climate change impact tracks' serviceability?"
  • Their Earthworks product provides ground engineering intelligence across multiple verticals, including EarthWorks Rail for railway infrastructure assessment, and Earthworks Property for large property installations.