Insights

FDA IVD review process has changed; how should manufacturers adapt?

A surge in premarket submissions during Covid-19 led the FDA to realign its review process for IVDs. Consequently, many device manufacturers need to revisit their regulatory...

Diagnostics Diagnostics consumables Medical devices Point of care diagnostics Regulation

FDA IVD review process has changed; how should manufacturers adapt?

A surge in premarket submissions during Covid-19 led the FDA to realign its review process for IVDs. Consequently, many device manufacturers need to revisit their regulatory...

Diagnostics Diagnostics consumables Medical devices Point of care diagnostics Regulation

Farming is a numbers game. But in the face of climate impacts, resource scarcity, water pressures, biodiversity loss and ever diminishing soil quality, maintaining livelihoods...
Fancy a pint of AI beer? While that may sound futuristic or that Silicon Valley is taking over the brewing industry...
We are constantly producing data. Our mobile phones, cars, smart meters and kitchen appliances measure everything we do...
It’s six months since Francisco Siro joined Sagentia Innovation to lead the advisory side of the business. As a...
Rob Morgan, Laurie Clarke, and Eduardo von Ristow have a round table discussion about how to integrate FDA regulating...
On the journey to parenthood, infertility is one of the most distressing challenges prospective parents can face. While...
From improving health to fighting climate change, the potential benefits of a plant-based diet regularly hit the...
Evidence suggests Covid-19 has enhanced our collective awareness of global issues. In addition, research shows that...
Sustainability, inclusivity and brand trust are influencing the buying behaviour of consumers across multiple sectors...
Endoscopes are essential visualisation tools in modern medicine but due to cleanliness concerns single-use endoscopes...
Steve Brown and Nick Collier share 9 top learnings when designing and developing diagnostic Point of Care assays from...
In recent times, we've seen a convergence of technical capabilities, healthcare industry needs and wider acceptance of...
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