The rise of the medical 3D-printing market in the wake of Covid-19
3D printing, or additive manufacturing, enables fabrication of 3D structures that are very complex and specific, prohibitively expensive, or impossible…
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Precision medical wire in pacemakers: living life at your own pace
Pacemaker implantation is one of the most common types of heart surgery that is carried out, in fact, as of…
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US FDA clears Masimo’s handheld pulse oximetry device
The US Food and Drug Administration (FDA) has cleared Masimo’s handheld pulse oximetry device called Rad-G Pulse Oximeter. The rugged handheld device delivers clinically proven…
Abbott secures CE-Mark for real-time glucose monitoring device
Abbott has received CE Mark approval for its FreeStyle Libre 3 system for people living with diabetes in Europe. The system offers real-time glucose readings…
FDA approves Medtronic’s insulin delivery and monitoring system
The US Food and Drug Administration (FDA) has approved Medtronic’s MiniMed 770G System for use by paediatric patients aged between…
Biotricity to sign licensing agreement with MD Matrix
US-based medical diagnostic and consumer healthcare technology company Biotricity has agreed to sign a licensing agreement with telemedicine company MD…
Novalis invests in Enzyre for haemophilia monitoring device
Novalis Biotechnology Incubation has invested in Enzyre to support the development of Enzypad, a hand-held diagnostic and monitoring device for…
FDA approves Abbott’s iOS-compatible app for chronic pain patients
Abbott has received approval from the US Food and Drug Administration (FDA) for the use of the company's iOS-compatible Patient…
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CardieX secures patent in Europe for blood pressure technology
CardieX subsidiary ATCOR has secured a new patent by the European Patent Office (EPO) for its SphygmoCor technology used in…
Abbott introduces glucose sport biosensor for athletes
Abbott has introduced a glucose sport biosensor for athletes based on its FreeStyle Libre continuous glucose monitoring technology, originally developed…
Company Tailored MDR / IVDR Gap-Assessment
You do not have the time or resources to prepare a gap-assessment over your company and products? No problem. We…
MDSAP vs ISO 13485:2016 Checklist
The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation…
Regulatory Intelligence Paper
Remain informed about upcoming rules, regulations, guidance, and standards. According to the new MDR, IVDR, and ISO 13485:2016, it is…
IVDR GAP-Assessment Tool
Our IVDR gap assessment tool is our basic version. This tool contains complete IVDR with all chapters (1 - 10)…