EU: Commission drives digital health by establishing new European Health and Digital Executive Agency

2023-03-31T11:05:13+00:00April 7th, 2021|Categories: Europe|Tags: , , |

The European Commission has established a new executive agency, the European Health and Digital Executive Agency (HaDEA) for digital and health projects. The agency is expected to help Europe emerge stronger from the COVID-19 pandemic.The new HaDEA will be responsible [...]

EU: European Union and Commission launch EU4Health funding program to boost healthcare digitalization and make devices more accessible

2023-03-31T13:23:04+00:00March 30th, 2021|Categories: Europe, Innovation|Tags: , , , |

As COVID-19 keeps surging throughout many of the European countries, the EU and EU Commission launched EU4Health, the €5.1 billion funding program targeting EU countries, health organisations and NGOs. Aim of the program is to strengthen the resilience of post [...]

US: FDA provides examples on real world evidence to support marketing applications for medical devices

2024-02-29T16:54:30+00:00March 19th, 2021|Categories: Clinical Trial, USA|Tags: , , , , |

The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices. The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption [...]

US: FDA Releases Artificial Intelligence/Machine Learning Action Plan

2024-02-29T17:06:58+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: , , , , , , , |

The FDA has released an action plan to develop a regulatory framework on artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). The FDA aims to publish the draft guidance this year. As a Digital Research Organization, Meditrial [...]

UK: MHRA supports generating RWE in clinical trials through digital solutions

2024-02-29T16:25:13+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: , , , , |

UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions. MHRA exaplained that real-world data source in [...]

US: FDA launches the Digital Health Center of Excellence

2024-02-29T16:51:55+00:00October 20th, 2020|Categories: Clinical Trial, USA|Tags: , , , , |

The U.S. Food and Drug Administration recently launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). "The launch of the Digital Health Center of Excellence is an important step in furthering the [...]

EU: EMA supports digital health technologies in clinical trials

2020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: , , , , |

Digital health technologies  are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]

US: FDA “green lights” the path for ePRO through regulation

2024-02-29T16:38:59+00:00September 3rd, 2020|Categories: Clinical Trial, Compliance, Regulatory, Software, USA|Tags: , , , , |

The FDA issued a guidance for the selection of patient-reported outcome (PRO) instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing PRO instruments as well as the possibility of including [...]

Dr. Tocchi lecture for Weill Cornell Medicine

2024-02-02T10:42:51+00:00July 21st, 2020|Categories: Innovation, USA|Tags: , , , , |

How to build a Regulatory and Clinical Strategy. Meditrial is thrilled to partner with Weill Cornell Medicine to help biotechnology inventors be successful in globalhealth. Dr. Monica Tocchi will hold a lecture on regulatory. Register here For more information, click [...]

USA: FDA issued guidance for remote patient monitoring devices used during COVID-19

2024-02-29T17:13:19+00:00June 9th, 2020|Categories: Covid-19, Regulatory, USA|Tags: , , , |

FDA issued "guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the [...]

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