USFDA nod for first AI device to help detect colon cancer
In the study, colonoscopy plus GI Genius was able to identify lab-confirmed adenomas or carcinomas in 55.1 per cent of patients…
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US FDA issues AI/ML Software as a Medical Device Action Plan
Based on stakeholder feedback, the Action Plan outlines five actions the US FDA intends to take
Impact of Viral mutation on molecular tests remains low: US FDA
Working with test developers and conducting ongoing data analysis to evaluate all currently authorised molecular tests
US FDA authorises 1st COVID-19 and flu combination test for use with home-collected samples
Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for…
US FDA draft guidance on EMC of med devices open for public comments for 60 days
Once finalised, this will replace the July 2016 US FDA guidance, “Information to Support a Claim of Electromagnetic Compatibility…
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Moderna’s mRNA COVID-19 vaccine candidate has 94.5% efficacy
EMA starts rolling review, company to submit for USFDA EUA in coming weeks
Inito clears US FDA regulatory pathway for fertility monitor
Becomes first Indian home diagnostic device startup to achieve the milestone
US FDA clarifies about Nov 2019 revisions on insulin pen packaging and dispensing
Strongly encouraged insulin pen manufacturers to consider developing smaller carton sizes to better accommodate variable insulin…
US FDA authorises first COVID-19 antigen test where results can be read directly from testing card
Cautions that negative results from antigen tests may need to be confirmed with a molecular test prior to making treatment…
FDA multiple-function device products update particularly affects telehealth: GlobalData
As a result of the new regulations, device manufacturers will implement separation and support segregation of device functions…