Keystone Heart and Vasorum enter distribution agreement for Celt ACD vascular closure device

Keystone Heart has signed a distribution agreement with Vasorum for sales and marketing of the Celt ACD vascular closure device. A press release reports that the Celt ACD is an arterial puncture closure device that has been used in more than 40,000 patients to date with excellent clinical results following percutaneous catheter-based vascular procedures.  [...]

2019-07-22T15:03:09+00:00July 22nd, 2019|Tags: , , |

US FDA approval for fourth-generation MitraClip

MitraClip XTR Abbott has received US FDA approval for fourth-generation version of its MitraClip heart valve repair device (MitraClip G4) to treat mitral regurgitation. This latest version, according to a press release, delivers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time [...]

2019-07-22T14:59:03+00:00July 22nd, 2019|Tags: , , |

Stephen Mason becomes CEO of Cardinal Health’s medical segment

Cardinal Health has announced that Stephen Mason, currently president of Cardinal Health at-Home Solutions business, has been promoted to CEO of Cardinal Health’s medical segment. Mason will succeed Jon Giacomin, who will be departing the company in mid-August to assume a CEO position at a privately-held company. A press release states that Mason is [...]

2019-07-22T14:55:27+00:00July 22nd, 2019|Tags: |

Clinical trial to evaluate use of NeuroPace RNS for managing uncontrolled eating in obese patients

A US FDA-approved, closed-loop neuromodulation system (RNS, NeuroPace) for medically refractory focal onset epilepsy is to be evaluated for managing loss-of-control eating in patients with body mass index (BMI) of 45-60 kg/m2 for whom medication and gastric bypass surgery have not been effective treatments and for whom loss-of-control eating is a contributing factor. A [...]

2019-07-22T14:51:00+00:00July 22nd, 2019|Tags: , |

Medtronic partners with Viz.ai to accelerate use of AI software in US stroke centres

Medtronic and Viz.ai—which focuses on applied artificial intelligence (AI) in stroke care—have partnered to accelerate the adoption of Viz.ai's new technology, which is designed to help synchronise stroke care and decrease time to treatment, potentially improving outcomes for patients. Viz.ai's technology uses AI to identify suspected large vessel occlusion strokes and automatically notify specialists. [...]

2019-07-22T14:42:17+00:00July 22nd, 2019|Tags: , |

CE mark for av-Guardian vascular access system

av-Guardian Advent Access has received the CE mark for its av-Guardian vascular access system. A press release reports that the av-Guardian is the world’s first implant technology to pioneer the concept of establishing a “guardian guide-door” to facilitate dialysis needles to optimally access an arteriovenous (AV) fistula, without being in contact with [...]

2019-07-15T13:38:17+00:00July 15th, 2019|Tags: , |

Brexit prompts UL International to cease operation in the UK

UL International (UK) (NB 0843) has taken the decision to cease operation as a Notified Body under the Council Directive, 93/42/EEC concerning medical devices (MDD). This will be effective from 1 September 2019. A press release notes this decision is in response to a potential “no deal” Brexit, explaining that a “no deal” will [...]

2019-07-15T13:34:41+00:00July 15th, 2019|Tags: , , |

Orchestra BioMed completes US $34 million financing to accelerate product pipeline development and advance partnerships

Orchestra BioMed has completed a US$34 million Series B-1 Preferred Stock financing—led by institutional investors Perceptive Advisors, RTW Investments and Soleus Capital with participation from strategic partner Terumo Corporation and existing investors from SternAegis Ventures. Additionally, Orchestra BioMed may receive up to an additional $57 million in follow-on investments from existing shareholders based on [...]

2019-07-15T13:30:55+00:00July 15th, 2019|Tags: , , |

Novel catheters with “mirror” enable operators to see device in vasculature in 3D

IntelliCath © Fraunhofer MEVIS A novel catheter (IntelliCath, Intelligent Catheter Navigation) has been equipped with a special optical fibre containing tiny “mirrors”; these mirrors help operators see how a device moves through a patient’s vasculature, in 3D, during a procedure. Torben Pätz (Fraunhofer MEVIS, Bremen, Germany) and his co-developers have already tested [...]

2019-07-15T13:26:29+00:00July 15th, 2019|Tags: , , |

US FDA 510(k) clearance for intraoperative positioning system

Centerline Biomedical has received 510(k) clearance from the US FDA to market its flagship product, the intraoperative positioning system (IOPS). A press release reports that IOPS is a non-radiation-based surgical navigation system for minimally invasive surgery that leverages anatomical mapping algorithms and electromagnetic tracking technology to provide 3D colour visualisation and guidance in real [...]

2019-07-15T11:55:13+00:00July 15th, 2019|Tags: , |