THINK Surgical, Inc. has announced that its TMINI Miniature Robotic System has received 510(k) clearance from the US Food and Drug Administration.The system, developed with Sagentia Innovation, includes a wireless robotic handpiece to help…
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GE HealthCare announced it received FDA 510(k) clearance for its Precision DL deep learning image processing software. Precision DL utilizes deep learning, a subset of AI and machine learning, to improve image quality on the…
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iHealthScreen, maker of AI-enabled software for retinal imaging, received FDA 510(k) clearance for its iPredict Eye Screening System that leverages AI to help providers determine if a patient over 50 has age-related macular degeneration. The…
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San Francisco-based predictive health company Potrero Medical has added former U.S. Secretary of Veterans Affairs, Dr. David Shulkin, to its advisory board. Shulkin has had a decades-long career in healthcare, from working at the higher…
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Following a successful launch in Europe, London-based medical device company Acurable is aiming to revolutionise sleep apnoea detection for Americans with the launch of its AcuPebble device for Obstructive Sleep Apnoea (OSA) diagnosis in…
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By Mark Melchionna
May 15, 2023 – A new study from the University of Washington School of Medicine (UW Medicine) found that despite an overall level of patient satisfaction with medication abortions, those that took place…
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Researchers at the University of New South Wales and Boston University have developed an AI tool, CRANK-MS, that can predict the onset of Parkinson’s disease years before symptoms appear. The tool analyzes blood samples…
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As of April 2023, the number of recruiting studies in the US was 24,138. Based on FDA data from new drug approvals in 2021, we can assume an average of 760 patients are needed…
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The FDA has finalized revised recommendations for assessing blood donor eligibility, ensuring uniformity regardless of sexual orientation, sex, or gender. Donors reporting new sexual partners, multiple partners, or engaging in anal sex within three…
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The FDA’s new draft guidance on Decentralized Clinical Trials (DCTs) is a landmark moment for the industry, emphasizing the importance of virtual trials for improving patient access to groundbreaking research while providing recommendations on…
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