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Bayer and Blackford Analysis Announce AI Platform Agreement in Radiology

BioTech 365

Bayer and Blackford Analysis Announce AI Platform Agreement in Radiology Bayer and Blackford Analysis Announce AI Platform Agreement in Radiology Bayer and Blackford Analysis have entered into a development and license agreement to establish an artificial intelligence (AI) platform for … Continue reading →

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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. About the author.

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Novartis builds radio-oncology pipeline with iTheranostics deal

pharmaphorum

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . Novartis licenses the drug from Genmab and reformulated into its Sensoready autoinjector pen.

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FDA says yes to MedCognetics breast cancer screening AI

pharmaphorum

The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world. It cites data estimating there is ten-fold higher demand for radiology services than available capacity, with around half of practitioners “experiencing depression or burnout” due to “unmanageable caseloads.”

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

XTalks

The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders. Magnus Medical received exclusive licensing rights to commercialize the SAINT (Stanford Accelerated Intelligent Neuromodulation Therapy) technology from Stanford University.

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MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD).

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AZD7442 reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial

The Pharma Data

The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower. The LAAB was generally well permitted in the trial.

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