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Home » Topics » Science » Artificial intelligence

Artificial intelligence
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AI biotech research concept with lightbulb and digital background

FDA inks draft guidance for AI applicable across product centers

Jan. 6, 2025
By Mark McCarty
Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI.
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Hourglass on glowing circuit board, symbolizing time and technology
Year in review

EU’s med-tech regulatory struggles continue into 2025

Jan. 3, 2025
By Mark McCarty
Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.
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Syncell Microscoop Mint

Syncell raises $15M series A for precise spatial proteomics tech

Dec. 19, 2024
By Marian (YoonJee) Chu
Taipei, Taiwan- and Watertown, Mass.-based Syncell recently raised $15 million in series A financing to advance its subcellular protein purification and spatial proteomics analysis product called Microscoop Mint, based on its Microscoop platform technology.
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Heartbeam

FDA clearance adds glow to Heartbeam prospects

Dec. 16, 2024
By Annette Boyle
Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously.
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Spotitearly dog

Spotitearly dogs AI to diagnose early cancer with tailwagging 95% accuracy

Dec. 6, 2024
By Annette Boyle
Bring your dog to work day looks a little different at Spotitearly. The Tel Aviv-based company asks its canine workers to bring their whole selves to the job – particularly their finely trained noses – to help suss out cancer in breath samples. The dogs’ unique capabilities are interpreted by AI to capture canine indicators humans might miss and the combo has remarkably high accuracy, 93% or better in three of the four common cancers tested.
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Ribbons of digital data

Hazards of prompt engineering a concern for regulation of GenAI

Nov. 26, 2024
By Mark McCarty
The health care potential for generative artificial intelligence comes with hazards such as the inadvertent effects of poor prompt engineering practices, but Anil Bhatta of Deloitte Consulting told a U.S. FDA advisory committee that this risk could be managed by rules that would thwart any consequent problems, such as an inadvertent jailbreak of the algorithm’s intended use.
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Female sitting on floor in dark room

Trivarx’s AI-based algorithm provides objective depression diagnosis

Nov. 26, 2024
By Tamra Sami
Diagnosing depression and other mental illnesses is largely subjective, but that could soon change as Sydney-based Trivarx Ltd. developed an AI-based algorithm that uses heart rate and heart rate variability coupled with sleep disturbance to diagnose major depressive episodes.
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Illustration of head with circuit board brain
HIF 2024

Neuralink just one part of ongoing BCI evolution

Nov. 26, 2024
By Marian (YoonJee) Chu
Fifty years after the term brain-computer interface (BCI) was coined, Neuralink and several other companies are reviving the promise of BCI for health care, as artificial intelligence and novel methods of neural signal detection work hand-in-hand to propel biomedical innovation.
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D-rendered image showing atlas of human embryonic skeletal development
Drug design, drug delivery & technologies

More than 100M cells included in the human cell atlas

Nov. 26, 2024
By Mar de Miguel
An international consortium of thousands of scientists is creating the Human Cell Atlas, a three-dimensional map of all the cells in the body. The goal is to understand all the cells that make up human tissues, organs and systems, which will enable multiple medical applications. This collection of cell maps is openly available for navigation at single-cell resolution, identified through omics analyses that reveal the tridimensional distribution of each cell.
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Digital pills on a circuit board

FDA advisory panel sees heightened risk in connection with GenAI

Nov. 25, 2024
By Mark McCarty
The first day of the U.S. FDA’s two-day advisory hearing on generative artificial intelligence reflected some of the anxieties attached to this emerging technology, with the phenomenon of hallucinations driving several calls for more stringent regulation of this class of products that might be applied toward other entries in the class of artificial intelligence.
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