Medical guideline

Pulnovo Medical Limited's PADN Technology Included in 2022 ESC/ERS Guidelines for the Diagnosis and Treatment of PH

Retrieved on: 
Wednesday, September 7, 2022

The Guidelines will provide physicians and patient families with the best recommendations and the latest evidence for the diagnosis and treatment of PAH worldwide.

Key Points: 
  • The Guidelines will provide physicians and patient families with the best recommendations and the latest evidence for the diagnosis and treatment of PAH worldwide.
  • PADN is a vascular interventional ablation technology that uses radiofrequency ablation to block pulmonary intima sympathetic nerves and reduce pulmonary artery pressure to delay disease progression.
  • The Guidelines include an introduction and analysis of the PADN technique as part of the treatment for PAH.
  • The single-blind, randomized, sham-operated controlled clinical study is designed to evaluate the safety and efficacy of PADN surgery for PAH.

New Analysis Published in Peer-reviewed Psychiatry Research Shows Advantages of Combinatorial Algorithm of GeneSight® Psychotropic Test

Retrieved on: 
Wednesday, February 23, 2022

The study shows the combinatorial approach used by GeneSight exceeds the effectiveness of single-gene testing at predicting sertraline metabolism in patients with major depressive disorder (MDD).

Key Points: 
  • The study shows the combinatorial approach used by GeneSight exceeds the effectiveness of single-gene testing at predicting sertraline metabolism in patients with major depressive disorder (MDD).
  • Using data (n=124) from the Genomics Used to Improve DEpression Decisions (GUIDED) randomized-controlled trial, the analysis evaluated the clinical validity of GeneSights combinatorial pharmacogenomic algorithm to predict sertraline blood levels.
  • Sertraline blood levels were compared between phenotypes based on: 1) the pharmacokinetic portion of the combinatorial pharmacogenomic algorithm, and 2) individual genes.
  • Psychiatry Research previously published two studies evaluating the combinatorial approach of the GeneSight test as compared to single-gene testing.

Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures

Retrieved on: 
Wednesday, February 23, 2022

Given the challenging patient population, the high technical success rate in this most demanding PCI environment is particularly notable.

Key Points: 
  • Given the challenging patient population, the high technical success rate in this most demanding PCI environment is particularly notable.
  • The CTO-PCI IDE study confirmed the safety and effectiveness of a range of these products in very complex CTO cases, said Teleflex Medical Director, Dr. Christopher Buller.
  • Interventional cardiologists who have evolved the techniques for these difficult procedures need innovative, enabling devices they can absolutely count on, he said.
  • Impact of Chronic Total Occlusion of the Coronary Artery on Long-Term Prognosis in Patients With Ischemic Systolic Heart Failure: Insights From the COMMIT-HF Registry.

Medical Device and Pharmaceutical Industries Can Leverage New GS1 US Guideline for Sharing Vital Data

Retrieved on: 
Thursday, July 29, 2021

EWING, N.J., July 29, 2021 /PRNewswire/ -- GS1 US has published a new guideline, " Best Practice Guide for Sharing Vital Attributes in Healthcare ," to help healthcare trading partners share data about medical devices or pharmaceutical products.

Key Points: 
  • EWING, N.J., July 29, 2021 /PRNewswire/ -- GS1 US has published a new guideline, " Best Practice Guide for Sharing Vital Attributes in Healthcare ," to help healthcare trading partners share data about medical devices or pharmaceutical products.
  • The guideline is a resource for healthcare professionals charged with master data management, procurement, regulatory compliance and data governance.
  • This guideline also covers data recommendations for the U.S. Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enabling pharmaceutical traceability and Unique Device Identification Rule (UDI) requirements for medical device traceability.
  • For more information about GS1 US, the guideline and additional data quality healthcare resources, visit www.gs1us.org.

Newsweek in Partnership with The Leapfrog Group Awards Magnolia Medical's Steripath Platform as Category-Exclusive Best Infection Prevention Product of 2021

Retrieved on: 
Tuesday, July 27, 2021

SEATTLE, July 27, 2021 /PRNewswire/ --Magnolia Medical announced today that Newsweek, in partnership with The Leapfrog Group, an independent, nonprofit healthcare industry watchdog organization that evaluates healthcare quality, designated the Steripath Initial Specimen Diversion Device as a Best Infection Prevention Product of 2021 .

Key Points: 
  • SEATTLE, July 27, 2021 /PRNewswire/ --Magnolia Medical announced today that Newsweek, in partnership with The Leapfrog Group, an independent, nonprofit healthcare industry watchdog organization that evaluates healthcare quality, designated the Steripath Initial Specimen Diversion Device as a Best Infection Prevention Product of 2021 .
  • This is the second year in a row Steripath has been the only blood culture collection and contamination reduction system named to the distinguished list.
  • This recognition, along with major formal policy and guideline changes, affirm the criticality of our Steripath technology platform to help solve this longstanding patient safety and healthcare quality issue."
  • Magnolia Medical invented and patented the Initial Specimen Diversion Technique (ISDT) and Device (ISDD) for blood culture collection and contamination prevention.

Statement of FTC Chair Lina Khan and Antitrust Division Acting Assistant Attorney General Richard A. Powers on Competition Executive Order’s Call to Consider Revisions to Merger Guidelines

Retrieved on: 
Friday, July 9, 2021

The following statement can be attributed to Federal Trade Commission Chair Lina Khan and Acting Assistant Attorney General of the Justice Department Antitrust Division Richard A.

Key Points: 
  • The following statement can be attributed to Federal Trade Commission Chair Lina Khan and Acting Assistant Attorney General of the Justice Department Antitrust Division Richard A.
  • Powers:

    We must ensure that the merger guidelines reflect current economic realities and empirical learning and that they guide enforcers to review mergers with the skepticism the law demands.

  • The current guidelines deserve a hard look to determine whether they are overly permissive.
  • We plan soon to jointly launch a review of our merger guidelines with the goal of updating them to reflect a rigorous analytical approach consistent with applicable law.

Statement of FTC Chair Lina Khan and Antitrust Division Acting Assistant Attorney General Richard A. Powers on Competition Executive Order’s Call to Consider Revisions to Merger Guidelines

Retrieved on: 
Friday, July 9, 2021

The following statement can be attributed to Federal Trade Commission Chair Lina Khan and Acting Assistant Attorney General of the Justice Department Antitrust Division Richard A.

Key Points: 
  • The following statement can be attributed to Federal Trade Commission Chair Lina Khan and Acting Assistant Attorney General of the Justice Department Antitrust Division Richard A.
  • Powers:

    We must ensure that the merger guidelines reflect current economic realities and empirical learning and that they guide enforcers to review mergers with the skepticism the law demands.

  • The current guidelines deserve a hard look to determine whether they are overly permissive.
  • We plan soon to jointly launch a review of our merger guidelines with the goal of updating them to reflect a rigorous analytical approach consistent with applicable law.

BGI Statement in Response to Reuters Report

Retrieved on: 
Friday, July 9, 2021

As a leader in life science and gene technology, BGI is committed to improving health outcomes worldwide.

Key Points: 
  • As a leader in life science and gene technology, BGI is committed to improving health outcomes worldwide.
  • Assertions that BGI is motivated by anything other than the advancement of health outcomes are both deeply disappointing and factually incorrect.
  • Contrary to assertions by Reuters, BGI's NIPT test was developed solely by BGI not in partnership with China's military.
  • Wherever BGI undertakes research, the companystrictly comply with local laws, guidelines, and protocols, while adhering to internationally recognized ethical standards.

BGI Statement in Response to Reuters Report

Retrieved on: 
Friday, July 9, 2021

As a leader in life science and gene technology, BGI is committed to improving health outcomes worldwide.

Key Points: 
  • As a leader in life science and gene technology, BGI is committed to improving health outcomes worldwide.
  • Assertions that BGI is motivated by anything other than the advancement of health outcomes are both deeply disappointing and factually incorrect.
  • Contrary to assertions by Reuters, BGI's NIPT test was developed solely by BGI not in partnership with China's military.
  • Wherever BGI undertakes research, the companystrictly comply with local laws, guidelines, and protocols, while adhering to internationally recognized ethical standards.

BIOMEDevice Returns to Boston This September 21-22 to Inspire the Next Life-Changing Medical Device

Retrieved on: 
Friday, June 25, 2021

"Progress in healthcare is driven by two powerful forces: continued education that facilitates discovery and industry-wide collaboration.

Key Points: 
  • "Progress in healthcare is driven by two powerful forces: continued education that facilitates discovery and industry-wide collaboration.
  • New to the BIOMEDevice brand, the exhibition floor will feature two Show Floor Zones dedicated to 3D Printing and Robotics.
  • Each Zone will serve as a networking hub for attendees to mingle and meet suppliers specializing in their respective zone.
  • These guidelines will help to ensure participants maximize their time while feeling confident and safe.