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On-demand webinar: What you need to know about USP <1085>
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
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Medical Devices
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UK set to produce 70 percent of PPE required domestically by December
Due to the demand caused by the COVID-19 pandemic, the UK government has said British manufacturers will produce the majority of PPE by the end of the year.
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Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
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Artificial pancreas for type 1 diabetes control given nod by FDA
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
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The trials and tribulations of the medical devices and IVD regulations
This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
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Intraoperative radiotherapy as effective as external beam radiotherapy, finds study
Researchers reveal that for early breast cancer a single dose of targeted intraoperative radiotherapy (TARGIT-IORT) is as effective at preventing breast cancer recurrence as the standard of care.
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Three tips to manufacture quality compliant PPE
Dr Stephane Gobron explores three different ways that manufacturers can use to bring their PPE up to regulatory standard.
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Biosimilar uptake will take more than competitive pricing
This article explores what pharmaceutical companies could be doing to promote injectable biosimilar approval and consumer uptake.
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Cervical dysplasia treatment device approved for global Phase III trial
The cervical dysplasia drug-device product, APL-1702 (Cevira®), offers an alternative to surgery and has been approved to start a clinical trial in China and several other countries.
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FDA approves new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring
Abbott’s Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices are given approval.
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Sustainable biomedical device promising for regenerative medicine, say researchers
The sustainable device, consisting of food industry by-products, had excellent biocompatibility both in vitro and in vivo.
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Collaborating in the fight against COVID-19
The founder of Apple Steve Jobs once said, “Great things in business are never done by one person; they’re done by a team of people.” This is true now more than ever as medical device manufacturers and companies from a range of industries work together in the fight against COVID-19.…
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‘At home’ COVID-19 antibody tests: expert opinions and manufacturer warnings
Abbott has revealed its SARS-CoV-2 antibody test was not designed for at home use despite companies selling them for this purpose. Also, what do experts think about these tests?
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Spartan’s COVID-19 test recall exposes issues of rapid medical device approval, says report
Following the recall of Spartan Bioscience's COVID-19 test by Health Canada, a report suggests this demonstrates the challenges associated with rapid approval.
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Comprehensive consultation, validation, training and support
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC) specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using US Food and Drug Administration-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
