Medtech Regulatory News
Vision-based monitoring service receives FDA clearance for vital signs product
Vision-based patient monitoring service Oxehealth has been granted De Novo clearance by the US Food and Drug Administration for its Oxehealth Vital Signs product, which is incorporated into Oxevision. Read more
31 Mar 2021
Medtronic receives FDA approval for Harmony TPV therapy
Medtronic has received FDA approval for its Harmony Transcatheter Pulmonary Valve (TPV), a minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle. Read more
29 Mar 2021
Medtronic receives CE mark for SenSight system for DBS therapy
Medtronic has received the CE mark for the SenSight directional lead system for Deep Brain Stimulation (DBS) therapy as treatment of symptoms associated with movement disorders and epilepsy. Read more
22 Mar 2021
Notified body recommends medical device approval for erectile dysfunction treatment
Futura Medical, a company developing a portfolio of products based on its transdermal DermaSys drug delivery technology and currently focussed on sexual health and pain, has announced that the EU Notified Body has completed its review of MED3000. Read more
22 Mar 2021
Hand-out Boston Scientific Corporation
Boston Scientific receives FDA approval for TheraSphere device
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval of the TheraSphere Y-90 Glass Microspheres, developed for the treatment of patients with hepatocellular carcinoma (HCC). Read more
19 Mar 2021
Turn and face the strange: Adapting to regulatory changes
Ian Bolland caught up with Alan Finnerty, technology director at Medovate, to establish how the company is adapting to a changing regulatory landscape following Brexit. Read more
12 Apr 2021
The UK Medical Device Information System – A new resource for medtechs
Mark Wasmuth the CEO of the GMDN Agency (www.gmdnagency.org/), the international not-for-profit body, explains the functions of the UK Medical Device Information System. Read more
31 Mar 2021
Software as a Medical Device - Demystifying EU MDR
Thomas ET, senior associate, medical devices, Freyr, explains how EU MDR will apply to companies with Software as a Medical Device (SaMD). Read more
22 Mar 2021
Mastering mass change: how global labelling solutions can help your business
Warren Stacey, SVP global sales, PRISYM ID, explains the benefits of global labelling solutions to medical device manufacturers during changing times. Read more
3 Mar 2021
How to manage the impact of COVID-19 on IVDR timelines
Angela Brown, global head and senior director, regulatory affairs and Nicole A. Cowan, director, project management, IVD operations & strategy, examine how IVD manufacturers can meet 2022 deadlines despite the COVID-19 pandemic. Read more
23 Feb 2021
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Take to the stage: A preview of Med-Tech Innovation Expo's conference line-up
Med-Tech Innovation’s conference team guide us through what to expect across three stages for September’s show. Read more
Interventional robotics developer closes $5.7m seed round
Moray Medical, developers of the Coral interventional robotics platform, has completed its seed round totalling $5.7 million with the European HealthTech VC Heal Capital and several prominent angel investors joining the company's investor base. Read more
12 Apr 2021
Hologic to acquire Mobidiag in €668m deal
Mobidiag, a Finnish-French developer of innovative molecular diagnostic tests and instrumentation, has signed a definitive agreement to be acquired by Hologic, a women's health specialist, for approximately €668 million. Read more
9 Apr 2021
Nominations open for 2021 Digital Health Innovation Future Digital Awards
Juniper Research has announced that the 2021 Digital Health Innovation Future Digital Awards are open. Read more
9 Apr 2021
Amgen and Liva Healthcare forge cardiac rehabilitation partnership
Biotechnology firm Amgen and digital health coaching company Liva Healthcare, a new partnership to make cardiac rehabilitation accessible to more patients in the immediate aftermath of a heart attack. Read more
8 Apr 2021
Irish start-up strikes U.S. distribution agreement for ostomy barrier rings
US-based Medline and Ostoform, an Ireland-based start-up, have partnered for the commercialisation of a range of ostomy barrier rings in the US. Medline will distribute the Ostoform product range across the continuum of care. Read more
8 Apr 2021
A world without antibiotics - interview with Dr Henry Skinner
Reece Armstrong speaks to Dr Henry Skinner, CEO of the AMR Action Fund - a collective venture set up in collaboration with the World Health Organisation to raise investment for pharma companies developing new antibiotics to combat AMR. Read more
12 Apr 2021
Turn and face the strange: Adapting to regulatory changes
Ian Bolland caught up with Alan Finnerty, technology director at Medovate, to establish how the company is adapting to a changing regulatory landscape following Brexit. Read more
12 Apr 2021
Bridging the gap: How calcium sulphate is used to fill bone voids
Ian Bolland caught up with Mike Harris, CEO of Biocomposites, to discuss the use of its calcium sulphate product used a bone void filler. Read more
9 Apr 2021
Radar for medical imaging and monitoring
Dr Nigel Whittle, head of medical & healthcare at Plextek explores the potential use of microwaves for medicine. Read more
8 Apr 2021
Q&A: The importance of self-care and the tech to support it
Professor Maureen Baker, chief medical officer, and Matteo Berlucchi, CEO of Healthily, speak to Med-Tech Innovation News about the importance of self-care, its uses and how it can help alleviate pressure on health services. Read more
9 Apr 2021
The Midlands: An engine for innovation that can help reduce global health inequalities
Dr Nik Kotecha, CEO of Morningside Pharmaceuticals, and Professor Kamlesh Khunti, director of the Centre for BME Health, explain how the Midlands can be an engine to help address health inequalities. Read more
8 Apr 2021
Provider collaboratives: The next big customer group for medtech?
Oli Hudson, content director at Wilmington Healthcare, looks into one of the headline points of the new NHS White Paper, and explores what this might mean for the industry. Read more
1 Apr 2021
Empowering healthcare supply chains with IoT
Vincent Videlaine, Impinj director of business development EMEA, considers the resilience benefits of IoT. Read more
30 Mar 2021
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Take to the stage: A preview of Med-Tech Innovation Expo's conference line-up
Med-Tech Innovation’s conference team guide us through what to expect across three stages for September’s show. Read more
The MedTalk Podcast
A world without antibiotics - interview with Dr Henry Skinner
Reece Armstrong speaks to Dr Henry Skinner, CEO of the AMR Action Fund - a collective venture set up in collaboration with the World Health Organisation to raise investment for pharma companies developing new antibiotics to combat AMR. Read more
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