Cerebral arteries

Protembis Announces FDA Approval of its Pivotal Investigational Device Exemption (IDE) Study

Retrieved on: 
Thursday, October 19, 2023

Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816).

Key Points: 
  • Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816).
  • The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30-days, with stroke neurologists adjudicating the neurological events.
  • “We are delighted to announce that the pivotal IDE trial has been approved by the US FDA.
  • The Protembis team is working hard with our investigational sites, which are high volume TAVR centers and world-renowned academic centers of excellence, to ensure study activation is achieved expeditiously.

Methinks receives CE Marked Certification for AI-based stroke triage software

Retrieved on: 
Tuesday, February 21, 2023

BARCELONA, Spain, Feb. 21, 2023 /PRNewswire/ -- Methinks, a digital health Company that specializes in early detection and management of Acute Stroke (AS), using artificial intelligence (AI), today announced that it has received CE mark for its medical imaging software, Methinks Stroke Suite following a milestone year of development progress, enabling commercialization in Europe and to assist in emergency settings for the benefit of AS patients.

Key Points: 
  • Methinks Stroke Suite is the first CE marked medical device that assists in finding large vessel occlusions (LVO) both hyperdense and not.
  • Acute stroke is a serious life-threatening medical condition that affects approximately 17 million people globally each year.
  • Methinks Stroke Suite, AI-based software, is a radiological computer aided triage and notification system which uses AI algorithms to identify suspected LVO on non-contrast computed tomography (NCCT) images and computed tomography angiography (CTA).
  • Pau Rodriguez, CEO of Methinks, said: "We are delighted with the CE mark approval for our medical imaging software, Methinks Stroke Suite, which paves the way to enhance stroke patient outcomes by decreasing detection time and reducing disabilities.

Methinks receives CE Marked Certification for AI-based stroke triage software

Retrieved on: 
Tuesday, February 21, 2023

BARCELONA, Spain, Feb. 21, 2023 /PRNewswire/ -- Methinks, a digital health Company that specializes in early detection and management of Acute Stroke (AS), using artificial intelligence (AI), today announced that it has received CE mark for its medical imaging software, Methinks Stroke Suite following a milestone year of development progress, enabling commercialization in Europe and to assist in emergency settings for the benefit of AS patients.

Key Points: 
  • Methinks Stroke Suite is the first CE marked medical device that assists in finding large vessel occlusions (LVO) both hyperdense and not.
  • Acute stroke is a serious life-threatening medical condition that affects approximately 17 million people globally each year.
  • Methinks Stroke Suite, AI-based software, is a radiological computer aided triage and notification system which uses AI algorithms to identify suspected LVO on non-contrast computed tomography (NCCT) images and computed tomography angiography (CTA).
  • Pau Rodriguez, CEO of Methinks, said: "We are delighted with the CE mark approval for our medical imaging software, Methinks Stroke Suite, which paves the way to enhance stroke patient outcomes by decreasing detection time and reducing disabilities.

Mentice AB intends to acquire all assets related to the software solution Ankyras from the Spanish corporation Galgo Medical S.L.

Retrieved on: 
Thursday, June 9, 2022

The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.

Key Points: 
  • The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.
  • However, the solution has been developed for a long time by Galgo and the software Ankyras is patent protected and CE-marked product (Medical Device Regulation MDR) with technology published by Galgo since 2013.
  • Ankyras is an advanced cloud-based analysis solution that allows a physician to plan treatment for a specific patient.
  • This disclosure contains information that Mentice AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

Mentice AB intends to acquire all assets related to the software solution Ankyras from the Spanish corporation Galgo Medical S.L.

Retrieved on: 
Thursday, June 9, 2022

The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.

Key Points: 
  • The Acquisition is characterized as a technology acquisition as this solution is in an early phase of its commercialization.
  • However, the solution has been developed for a long time by Galgo and the software Ankyras is patent protected and CE-marked product (Medical Device Regulation MDR) with technology published by Galgo since 2013.
  • Ankyras is an advanced cloud-based analysis solution that allows a physician to plan treatment for a specific patient.
  • This disclosure contains information that Mentice AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014).

Global Percutaneous Transluminal Angioplasty Balloons Catheter Market Report to 2028 - Size, Share, Outlook, and Opportunity Analysis - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 26, 2022

The "Percutaneous Transluminal Angioplasty Balloons Catheter Market, by Type, by Material, by Application, by Diameter Size, by End User and by Region - Size, Share, Outlook, and Opportunity Analysis, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Percutaneous Transluminal Angioplasty Balloons Catheter Market, by Type, by Material, by Application, by Diameter Size, by End User and by Region - Size, Share, Outlook, and Opportunity Analysis, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.
  • Percutaneous transluminal angioplasty (PTA) is a procedure that opens up blocked peripheral arteries due to plaque build-up (atherosclerosis).
  • A series of x-ray images are taken to clearly view the narrowed artery after the catheter is advanced into the narrowed artery.
  • Increasing launches of angioplasty balloons catheter products in the market by key players are expected to drive the global percutaneous transluminal angioplasty balloons catheter market growth during the forecast period.