Doctors Radiology Regulation 
pharmaphorum
JUNE 3, 2021
Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched “in the coming months” At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence.
pharmaphorum
JUNE 18, 2021
Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well. The next steps?
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pharmaphorum
FEBRUARY 3, 2021
The information comes from preoperative radiological imaging data and aims to guide the surgeon during operations, increasing precision. In 2018 Novarad’s OpenSight Augmented Reality System was given the green light by the US FDA , allowing doctors to see inside patients before an operation.
pharmaphorum
DECEMBER 11, 2022
It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. When you get to a regulated intervention, evidence generation, validation of claims all the way to pricing and reimbursement – then, we’re talking about digital therapeutics.”.
XTalks
DECEMBER 14, 2023
We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the FDA’s news release. “We
The Pharma Data
NOVEMBER 17, 2020
doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. director of FDA’s Center for Devices and Radiological Health. . .
pharmaphorum
MARCH 16, 2021
We can use the content of the EHRs via artificial intelligence which benefits doctors’ time, and their ability to do research. I started talking about it with other doctors and thought ‘What if we applied some sort of computational linguistics?’ The technology is being embraced by doctors around the world according to Medrano.
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