About Dawn Powell

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So far Dawn Powell has created 334 blog entries.

COVID-19: New FDA guidance allows use of KardiaMobile 6L to measure QTc in virus patients

Kardia 6L AliveCor’s KardiaMobile 6L—the world’s only six lead personal ECG—is now allowed for use in the measurement of a patient’s QTc and detection of potentially dangerous QT prolongation.  A prolonged QTc can lead to a potentially fatal side effect, which is associated with the use of several medicines now being used [...]

2020-03-30T10:19:17+00:00March 30th, 2020|Tags: , , |

COVID-19: European Commission looking to postpone new MDR by one year

During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of the global coronavirus pandemic. de Keersmaecker, who spoke via video, said: “The EC [...]

2020-03-27T17:28:57+00:00March 27th, 2020|Tags: , |

Selective endovascular cooling with TwinFlo catheter shows promise for neuroprotection in stroke patients

Ron Solar Ron Solar (ThermopeutiX, San Diego, USA) and colleagues report in EuroIntervention that the TwinFlo catheter (ThermopeutiX), in pigs, was associated with rapid, selective, deep cerebral hypothermia. They add that the catheter may “offer an improved method for neuroprotection during neurosurgery, cardiac arrest, acute stroke, and other ischaemic insult”. Solar talks [...]

2020-03-27T16:30:27+00:00March 27th, 2020|Tags: , , |

Approvals & refusals—February 2020

In February, Abbott received FDA Breakthrough Device Designation for a fully implantable left ventricular assist device, Biotronik received the CE mark for its Osiro Mission drug-eluting stent, and BlueGrass Vascular Technologies got a FDA de novo classification order for its Surfacer Inside-Out access catheter system. CE marks CE mark—Fist compression device (Fist Assist Devices) [...]

2020-03-05T12:19:16+00:00March 5th, 2020|Tags: |

HydroPICC central catheter from Access Vascular receives FDA clearance

Hero Access Vascular has announced that it has received clearance from the FDA for the second generation of its HydroPICC peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs and the potential to significantly reduce catheter occlusions. PICCs have become an increasingly popular [...]

2020-03-05T11:19:12+00:00March 5th, 2020|Tags: , , , |

ATEC agrees to acquire EOS imaging

EOSedge Alphatec Holdings (ATEC) has announced that it has entered into an agreement to acquire EOS imaging for a purchase price of up to US$88 million, plus debt retirement of US$33.9 million, in a combination of cash and equity. EOS imaging is specialist in orthopaedic medical imaging and software solutions. The EOS technology [...]

2020-03-05T11:09:44+00:00March 5th, 2020|Tags: , , , |

Approval of Tendyne TMVI device means physicians now have a portfolio of options for treating mitral regurgitation

In January this year, Abbott made history when it became the first company in the world to receive market approval for a transcatheter mitral valve implantation (TMVI) device. Its Tendyne system now has a CE-mark indication for the management of patients with mitral regurgitation who cannot undergo mitral valve surgery or percutaneous edge-to-edge repair [...]

2020-03-05T10:17:44+00:00March 5th, 2020|Tags: , , |

Veterans study suggests surgery is still dominant revascularisation approach for critical limb ischaemia

Saket Girotra A review of data from Veteran Health Administration shows that there was a temporal increase in the use of revascularisations for the management of critical limb ischaemia between 2005 and 2014. This increase correlated with a reduction in both mortality and major amputation during the same time period. However, contrary [...]

2020-03-05T10:11:41+00:00March 5th, 2020|

Award for film raising awareness of aortic dissection

Film maker David Owens A short film (“Today is a Good Day”), which showcases the work of Aortic Dissection Awareness UK & Ireland, has won the Rare Disease Film Festival’s Peoples’ Choice award. According to Rare Disease UK, the organisers of the event, the film festival is the UK’s first-ever film event to be [...]

2020-03-05T09:52:30+00:00March 5th, 2020|Tags: , |

“Soft” robotic heart could be answer to donor heart shortage

Jolanda Kluin (Credit: BHF) A soft robotic heart that is designed to replace the need for a heart transplant is one of four research projects that have made the shortlist for the Big Beat Challenge initiative—organised by the British Heart Foundation—that awards £30m to a project that seeks to identify a real-world [...]

2020-02-27T13:52:36+00:00February 27th, 2020|Tags: , , |

Novel device “safely obliterates” left atrial appendage with minimal amount left behind

Leonid Sternik Append Medical, with their novel left atrial appendage (LAA) closure device (Appligator), were a finalist in the 2019 ICI Innovation Award Competition (Innovation in Cardiovascular Interventions 2019; 8–10 December, Tel Aviv, Israel). In this commentary, Leonid Sternik who came up with the concept for the device, outlines the need for [...]

2020-02-27T14:14:28+00:00February 27th, 2020|Tags: , |

Heart Research UK gives University of Leeds a grant to develop new treatments for heart failure

Scott Bowen A research project at the University of Leeds aiming to identify new drug treatments for heart failure patients has been awarded a grant of almost £150,000 by British charity Heart Research UK.  The project, which will be led by Scott Bowen (University of Leeds, UK), will investigate the causes of [...]

2020-02-27T13:32:48+00:00February 27th, 2020|Tags: , |

Fist Assist Devices announces CE mark for its compression device

Fist Assist Devices has received the CE mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union and other countries that recognise the CE mark. According to the press release, Fist Assist is the only wearable, patent-protected, intermittent compression device to increase vein diameter prior to [...]

2020-02-27T13:26:21+00:00February 27th, 2020|Tags: , , |

First patients enrolled in PROACTIVE-HF trial of Cordella pulmonary artery pressure sensor system

Cordella Endotronix has announced the enrolment of the first two patients in the PROACTIVE-HF trial. The trial is a premarket investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella pulmonary artery pressure sensor system (Cordella sensor) for the treatment of heart failure. The first two patients were successfully [...]

2020-02-27T13:19:12+00:00February 27th, 2020|Tags: , , |