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Tag: medical device regulation

Silk Road Medical Announces Post Approval Study for the Treatment of Standard Surgical Risk Patients using TCAR

SUNNYVALE, Calif., June 15, 2022 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and...

Remington Announces Launch of VascuChek®, A Wireless, Vascular Doppler Device

Remington Medical saw a need to improve the vascular flow check process for physicians worldwide. As a medical device manufacturer with more than 30...

Nanomix Receives IVDR Certification for the eLab AnalyzerIVDR certification enables Nanomix to market its eLab analyzer in the European Union under the newly established...

EMERYVILLE, Calif., June 14, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable,...

Blog Review: March 23

Memory translation; medical device regulation; reset domain crossing.

The post Blog Review: March 23 appeared first on Semiconductor Engineering.

EUROPEAN IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION

IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION Medical devices have a vital role in providing better diagnosis, prevention, Screening, monitoring, and treatment of various diseases. The COVID -19 pandemic challenge has shown the necessity to have accurate diagnostics and a stringent framework for the in vitro medical devices (IVDs). IVDs are biological tests that can detect …

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Virtual Care and Telemedicine: Regulatory trends

Virtual care and telemedicine services still suffer market penetration, user privacy, and regulatory concerns. Regulations are still evolving as technology evolves and is likely to remain a bottleneck to new product launches. Listed below are the key regulatory trends impacting the virtual care and telemedicine theme, as identified by GlobalData. Telehealth regulations Telehealth regulation was …

The post Virtual Care and Telemedicine: Regulatory trends appeared first on Medical Device Network.

UK med tech faces regulatory uncertainty post-Brexit

Following the UK’s exit from the EU, the regulatory landscape for medical devices remains uncertain. Andrew Thompson, PhD, director of therapy research & analysis at GlobalData, explains what companies need to know.

The post UK med tech faces regulatory uncertainty post-Brexit appeared first on Medical Device Network.

Good Design is Good Business Strategy

Good design is good business strategy. Simply having stunning technology is not enough to achieve market success and sustained profitability. R&D might have developed a revolutionary innovation. But if you fail to package the innovation in a well-considered design that addresses both aesthetics and usability, you will leave a lot of money on the table. [...]

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