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AZmed’s AZchest Receives Two FDA Clearances for AI-Powered Software Applications

XTalks

AZchest, a clinically validated AI radiology solution, automatically identifies, classifies and generates reports on key cardiac and pulmonary abnormalities in chest X-rays. It features FDA-cleared and CE-marked solutions designed to enhance radiology workflows by prioritizing urgent cases and accelerating treatment planning.

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Magnus Medical’s SAINT Neuromodulation System Gets FDA Clearance to Treat MDD

XTalks

Related: Xtalks Voices: Magnus Medical CEO Dr. Brett Wingeier Talks About Neurostimulation for Depression – Xtalks Life Science Podcast Ep. The neurostimulation devices market is expected to grow at a compound annual growth rate (CAGR) of 13 percent to reach $14 billion by 2030. The SAINT Neuromodulation Trial.

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New HCV Test Enables Diagnosis and Treatment in a Single Visit

XTalks

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). North America dominated the market in 2018 with a 47.46 percent share.

RNA 97
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Bayer delivers on medical innovation fueling transformation of pharma business

The Pharma Data

Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.

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Symbiotica and Quidel Score FDA Authorizations for COVID-19 Tests

XTalks

The new, revised EUA will allow the company to market the test for the qualitative detection of SARS-CoV-2 from nasal swab samples for screening use with serial testing. The EUA allows for the marketing of the device in the US.

Antibody 102
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Rezzayo (Rezafungin) Becomes First New Treatment Option for Candidemia and Invasive Candidiasis in Over a Decade

XTalks

The primary endpoints were global cure (consisting of clinical cure, radiological cure and mycological eradication) at 14 days for the European Medical Agency (EMA), and a 30-day all-cause mortality for the US FDA. Rezafungin met the endpoints outlined by both the EMA and FDA.

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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 2.