Diagnostic

The US Food and Drug Administration (FDA) published a ruling in the Federal Register on April 19, adjusting the identifications of medical software in classification regulations to exclude functions that no longer fall under the scope of the agency’s regulatory authority. The ruling is effective immediately from the date of publication. Background: medical software and
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The Vietnamese Ministry of Health (MoH) published a draft decree (download link, in Vietnamese) intended to replace Decree No. 36/2016/ND-CP​ and its amendments, which form the legal framework for regulating medical devices in Vietnam. The draft, released as Official Dispatch No. 2271/BYT-TB-CT, consolidates the amendments made to the current decree and introduces new sections addressing
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The roles of CEN, Cenelec and HAS consultants Regarding development of hENs for medical devices, these efforts fall either to the European Committee for Standardization (CEN), which covers most types of medical devces, as well as the European Committee for Electrotechnical Standardization (Cenelec), which focuses on medical electrical equipment. Under the current Directives, European Commissioners
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In 2020, and for the past few years, our team has published blog posts summarizing the latest expectations that US Food and Drug Administration (FDA)’s Human Factors reviewers have shared during the Human Factors and Ergonomics Society (HFES) Health Care Symposium. Here’s Part 1 of our 2021 edition, focused on what we learned from individuals
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The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has postponed deadlines for regulating implantable devices and other medical products for which manufacturers or importers have already applied for licenses under the Medical Device Rules 2017. According to a recent CDCSO order, Notification S.O. 775(E) establishing regulation of the following medical devices
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Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a document (links in Japanese) explaining the updated requirements for package insert digitization. Starting on August 1, 2021, package inserts for all classes of medical devices and IVDs must be posted to the Medical Device Safety Information Posting System on the PMDA website, allowing them to be viewable using
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Following up on our earlier post providing details on Taiwan’s new medical device regulations, the following is a summary of noteworthy details that have subsequently become available. These are compiled from various announcements and guidance documents (all links in Chinese) published by the Taiwan Food and Drug Administration (TFDA). Unless otherwise specified, these changes will
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The European Commission’s Medical Device Coordination Group (MDCG) has published a Q&A reference document covering clinical investigation requirements under the Medical Devices Regulation (MDR). The new MDCG document includes 28 questions and answers, providing additional clarity on several issues regarding the MDR’s substantial clinical investigation requirements. Manufacturers preparing for the MDR’s May 26, 2021 final
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Switzerland’s Federal Office of Public Health (FOPH) announced that the Swiss Federal Council has opened a consultation on the In Vitro Diagnostics Ordinance (IvDO) and the corresponding amendments to the Ordinance on Clinical Trials for Medical Devices (ClinO-MD). This legislation aims to harmonize Switzerland’s regulatory system for IVDs to the European Union’s In Vitro Diagnostic
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Work has been completed on a new dual-site facility in Nottingham, England to develop the next generation of medical technologies.  Nottingham Trent University’s £23 million Medical Technologies Innovation Facility (MTIF) will bring organizations and clinicians together with university researchers to develop their ideas and get them to market as quickly as possible.Work now been completed
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Thermo Fisher Scientific has completed the acquisition of Henogen S.A., Novasep’s viral vector manufacturing business for $877 million in cash. Novasep’s viral vector manufacturing business provides contract manufacturing services for vaccines and therapies to biotechnology companies and large biopharma customers. With two locations in Seneffe and Gosselies, Belgium, Novasep’s viral vector business offers more than 7,000
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Medtronic has launched a trial to evaluate the safety and efficacy of its Percept PC technology using adaptive deep brain stimulation in patients with Parkinson’s Disease. The Dublin-based company said it enrolled the first patient in the study, which has been dubbed the Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD). ADAPT-PD will
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PerkinElmer is targeting asymptomatic people in its latest testing offering for COVID-19 testing. The Waltham, MA-based company said it has received emergency use authorization from FDA for its Nucleic Acid Detection Kit to test individuals without symptoms or other reasons to suspect COVID-19 infection. Here is the issue. About 60% of total COVID-19 transmissions come
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Last week, in response to a WIRED story about a 25-year-old bet between Kevin Kelly and Kirkpatrick Sale, we asked the MD+DI audience to be the judge of whether or not Sale’s predictions of technology destroying society had come to fruition. This week, during Medtech Unfiltred, News Editor Amanda Pedersen shares the results of that survey, along with
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FDA has released its holistic approach toward giving guidance for artificial intelligence and machine learning solutions. The federal agency’s first AI/ML-Based Software as a Medical Device Action Plan outlines five actions that the FDA intends to take, including:  Further developing the proposed regulatory framework, including through the issuance of draft guidance on a predetermined change
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Contrary to what conspiracy theorists would have you believe, neither Bill Gates nor Microsoft has any plans of using COVID-19 vaccines to implant microchips in billions of people. That said, Microsoft is playing a role in COVID-19 vaccinations. “Around the May timeframe, Microsoft partnered with FedEx around an opportunity to improve the supply chain logistics and
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