Category: Medtech

  • Medtech

PQ Bypass receives FDA “Breakthrough Device Designation” for the world’s first fully percutaneous femoral-popliteal Bypass device

PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Detour System. The Detour System is the world’s first fully-percutaneous femoral-popliteal bypass device intended to treat extremely long, complex blockages in the superficial …
  • Medtech

Quanta provides compact dialysis systems to NHS to support increased need caused by COVID-19 pandemic

Seroba’s portfolio company, Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a medical technology innovation company, today announced that it has been proudly supporting the ongoing National Health Service (NHS) COVID-19 response for emergency dialysis provision by supplying its next-generation SC+ hemodialysis system to select NHS Trusts in the United Kingdom. Quanta delivered an initial batch of equipment and trained …
  • Medtech

Endotronix announces enrollment of the first patients in the PROACTIVE-HF Pivotal Trial

Seroba’s portfolio company, Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella …
  • Medtech

CMS approves coverage for PQ Bypass TORUS 2 IDE Trial

Seroba’s portfolio company, PQ Bypass Inc, a medical device company bringing new advancements to the treatment of peripheral artery disease (PAD), has announced that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device Exemption (IDE) study titled TORUS 2. This approval will affect coverage across all Medicare administrative regions. TORUS …
  • Medtech

Endotronix announces positive data from the SIRONA First-in-Human Trial for the Cordella™ PA Pressure Sensor System

Seroba’s portfolio company, Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), presented positive first-in-human data of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). Data was presented at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, PA by Prof. Dr. Wilfried Mullens of the Hospital Oost-Limburg …
  • Medtech

PQ Bypass announces unconditional IDE Approval from U.S. FDA for pivotal study

PQ Bypass Announces Unconditional IDE Approval from U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2) Seroba’s portfolio company, PQ Bypass, Inc., a clinical-stage medical device company, today announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel stent graft platform designed for the treatment of peripheral …
  • Medtech

FDA approval for Endotronix Pivotal Trial

Seroba’s portfolio company, Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi-center PROACTIVE-HF trial of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). The innovative trial …
  • Medtech

Endotronix enrolls 1st patient in SIRONA II CE Mark Trial

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial, in Europe. The 60-patient study will evaluate safety and efficacy of the Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in support of its CE Mark submission. Cardiologist Prof. …
  • Medtech

Quanta SC+ confirmed as safe and easy to use

Seroba’s portfolio company, Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a pioneering medical technology company developing a personal haemodialysis system (SC+) for patient use in the clinic and the home, today announced that results from its human factors testing (HFT) of SC+ have been published in Hemodialysis International, a leading peer-reviewed journal for the renal community. SC+ was designed …
Subscribe to our Newsletter
* = required field