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FDA grants swift approval to Cognoa’s digital device for autism diagnosis

pharmaphorum

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.

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Philips DreamStation 2 CPAP Machines Get FDA Safety Warning

XTalks

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

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SurgAR and Medexprim start surgical AR partnership with French hospital

pharmaphorum

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.

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Four ways Biogen is tackling digital innovation in neurological disease

pharmaphorum

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.”.

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MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

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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Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

Carolyn R Bertozzi, PhD – Outstanding Achievement in Chemistry in Cancer Research Bertozzi is the Baker Family Director of Sarafan ChEM-H, the Anne T and Robert M Bass Professor in the School of Humanities and Sciences, Professor of Chemistry and, by courtesy, of Chemical and Systems Biology and of Radiology at Stanford University.

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Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

The Pharma Data

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. . .