Huma Therapeutics has received US Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software-as-a-Medical-Device (SaMD) platform, enabling companies to launch their own algorithm innovations more quickly to the platform and allowing…
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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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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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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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By Jill McKeon
May 03, 2023 – The US Food and Drug Administration (FDA) alerted healthcare providers and laboratory personnel of a cybersecurity vulnerability that impacts the Universal Copy Service (UCS) software in select Illumina medical…
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The US Food and Drug Administration (FDA) has released a statement urging healthcare providers and laboratory personnel to take necessary actions to mitigate cybersecurity risks in Illumina’s sequencing instruments. The FDA’s alert comes after…
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While Illumina has yet to receive any reports indicating this vulnerability has been exploited, according to a letter to healthcare providers from the U.S. Food and Drug Administration, bad actors could take control of…
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The FDA has updated its recommendations for the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Mask, allowing healthcare providers without alternative options to use this particular version of the mask for fluid barrier protection if…
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The agency recently posted new recommendations for AI developers who want to update their software as a medical device (SAMD). The document offers what we hope will be a less burdensome way to manage…
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