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Approvals

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Newly Cleared Cardiac Ultrasound Software Could Broaden Imaging User Base

The US FDA has cleared Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. In clinical trials, the system allowed untrained nurses to gather diagnostic-quality pictures and videos.

Diagnostic Imaging Approvals Research & Development

Latest From Approvals

QUOTED. 14 February 2020. Anne Schuchat.

The US Centers for Disease Control and Prevention (CDC) developed a diagnostic test relatively quickly after news hit that a new coronavirus is spreading across China. Now top health officials say diagnostic manufacturers should help scale up the production of these tests. See what Anne Schuchat, principal deputy director of the CDC, said about it here. 

Quoted Policy

QUOTED. 13 February 2020. Charles Cadieu.

The US FDA cleared Caption Health's Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. See what Caption Health's co-founder and president, Charles Cadieu, said about it here. 

Quoted Approvals

CDC Urges Diagnostics Makers To Scale Up Coronavirus Test

The second in command at the US Centers for Disease Control and Prevention said with the help of the Chinese government, the agency was quickly able to develop a diagnostic test for the new coronavirus – but now the private sector should use its resources to scale up production of the tests.

Commercial Policy

Newly Cleared Cardiac Ultrasound Software Could Broaden Imaging User Base

The US FDA has cleared Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. In clinical trials, the system allowed untrained nurses to gather diagnostic-quality pictures and videos.

Diagnostic Imaging Approvals

Novacyt, Co-Diagnostics, Other Test Firms Seek Fast-Track EUA Approval From FDA For Coronavirus Dx's

Diagnostics companies around the world – including Novacyt, Roche, Co-Diagnostics and Mammoth Biosciences – are developing and launching tests to fight the coronavirus in China and other countries as quickly as possible, and some are seeking Emergency Use Authorization (EUA) approval from the FDA so their assays can be used on US patients.

Regulation FDA

FDA Responds To Coronavirus By Getting Out First Emergency-Use Novel Coronavirus Diagnostic

The US agency on 4 February issued its first Emergency Use Authorization of a 2019-novel coronavirus test by enabling emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The move will allow use of the test at any CDC-qualified lab across the US.

In Vitro Diagnostics FDA

Abbott Stays Ahead Of Edwards In Transcatheter Mitral Valve Race With Tendyne CE Mark

Tendyne is indicated for the treatment of significant mitral regurgitation in patients who are not candidates for surgery. It complements Abbott’s MitraClip mitral valve repair device and is an important part of the company’s strategy to be the leading structural heart device company.

Approvals Clinical Trials

Eko’s AI Algorithm To Detect Heart Conditions Cleared By US FDA

US regulators have cleared a suite of cloud-based artificial intelligence software intended to be used with Eko’s digital stethoscopes to detect certain heart problems. The company says the AI algorithms are the first of its kind to be cleared by the US FDA.

Approvals Artificial Intelligence

FDA Commissioner Hahn’s Priorities Include Workplace Development Issues, Data Collection

Among Stephen Hahn’s priorities and long-term ambitions for his time at the US agency are retaining and recruiting the best possible professional staff, and collection and use of data, regulatory consultants and attorneys say.

Policy FDA
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