Neuralink says the Food and Drug Administration has designated its experimental Blindsight implant as a "breakthrough device." The company is developing the technology in an attempt to restore blind people's sight. Manufacturers who apply to the FDA's voluntary breakthrough devices program and receive the designation from the agency are granted "an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase." Ultimately, a breakthrough device designation can accelerate development of a technology. Last year, the FDA gave the designation to 145 medical devices.

Elon Musk's brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration's "breakthrough device" designation. The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up the development and review of devices currently under development. The experimental device, known as Blindsight, "will enable even those who have lost both eyes and their optic nerve to see," Musk said in a post on X. Neuralink did not immediately respond to a request seeking details about when it expects the Blindsight device to move into human trials. The FDA also did not immediately respond to a request for comment.

Apple is bringing sleep apnea detection to the most recent generations of its Watch, the company announced today. At the iPhones 16 launch event, Apple revealed the feature would come to the new Series 10, as well as the Series 9 and Ultra 2. If you wear your watch while you sleep, you'll get an alert in the morning if symptoms are detected through the night, urging you to visit your clinician. The data for this will be collated in the Health app on the iPhone. Rather than using oxygen saturation, which would be the logical approach, Apple says it's using motion tracking. This is likely related to the messy patent battle surrounding the blood oxygen sensor in the Watch that has stymied the company's work in this area.

Predicting unknown drug-drug interactions (DDIs) is crucial for improving medication safety. Previous efforts in DDI prediction have typically focused on binary classification or predicting DDI categories, with the absence of explanatory insights that could enhance trust in these predictions. In this work, we propose to generate natural language explanations for DDI predictions, enabling the model to reveal the underlying pharmacodynamics and pharmacokinetics mechanisms simultaneously as making the prediction. To do this, we have collected DDI explanations from DDInter and DrugBank and developed various models for extensive experiments and analysis. Our models can provide accurate explanations for unknown DDIs between known drugs. This paper contributes new tools to the field of DDI prediction and lays a solid foundation for further research on generating explanations for DDI predictions.

Prognostic and diagnostic AI-based medical devices hold immense promise for advancing healthcare, yet their rapid development has outpaced the establishment of appropriate validation methods. Existing approaches often fall short in addressing the complexity of practically deploying these devices and ensuring their effective, continued operation in real-world settings. Building on recent discussions around the validation of AI models in medicine and drawing from validation practices in other fields, a framework to address this gap is presented. It offers a structured, robust approach to validation that helps ensure device reliability across differing clinical environments. The primary challenges to device performance upon deployment are discussed while highlighting the impact of changes related to individual healthcare institutions and operational processes. The presented framework emphasizes the importance of repeating validation and fine-tuning during deployment, aiming to mitigate these issues while being adaptable to challenges unforeseen during device development. The framework is also positioned within the current US and EU regulatory landscapes, underscoring its practical viability and relevance considering regulatory requirements. Additionally, a practical example demonstrating potential benefits of the framework is presented. Lastly, guidance on assessing model performance is offered and the importance of involving clinical stakeholders in the validation and fine-tuning process is discussed.

Thomas VanCott compares his son Jake's experience with autism to life on a tightrope. Upset the delicate balance and Jake, 18, plunges into frustration, slapping himself and twisting his neck in seemingly painful ways. Like many families with children on the autism spectrum, Jake's parents sought treatments beyond traditional speech and behavioral therapies. One that seemed promising was magnetic e-resonance therapy, or MERT, a magnetic brain stimulation therapy trademarked in 2016 by a Newport Beach-based company called Wave Neuroscience. The company licensed MERT to private clinics across the country that offered it as a therapy for conditions including depression, PTSD and autism. Those clinics described MERT as a noninvasive innovation that could improve an autistic child's sleep, social skills and -- most attractive to the VanCott family -- speech. It was expensive -- 9,000 -- and not covered by insurance.

The concept of personalised medicine in cancer therapy is becoming increasingly important. There already exist drugs administered specifically for patients with tumours presenting well-defined mutations. However, the field is still in its infancy, and personalised treatments are far from being standard of care. Personalised medicine is often associated with the utilisation of omics data. Yet, implementation of multi-omics data has proven difficult, due to the variety and scale of the information within the data, as well as the complexity behind the myriad of interactions taking place within the cell. An alternative approach to precision medicine is to employ a function-based profile of the cell. This involves screening a range of drugs against patient derived cells. Here we demonstrate a proof-of-concept, where a collection of drug screens against a highly diverse set of patient-derived cell lines, are leveraged to identify putative treatment options for a 'new patient'. We show that this methodology is highly efficient in ranking the drugs according to their activity towards the target cells. We argue that this approach offers great potential, as activities can be efficiently imputed from various subsets of the drug treated cell lines that do not necessarily originate from the same tissue type.

Understanding the structure of the protein-ligand complex is crucial to drug development. Existing virtual structure measurement and screening methods are dominated by docking and its derived methods combined with deep learning. However, the sampling and scoring methodology have largely restricted the accuracy and efficiency. Here, we show that these two fundamental tasks can be accurately tackled with a single model, namely LigPose, based on multi-task geometric deep learning. By representing the ligand and the protein pair as a graph, LigPose directly optimizes the three-dimensional structure of the complex, with the learning of binding strength and atomic interactions as auxiliary tasks, enabling its one-step prediction ability without docking tools. Extensive experiments show LigPose achieved state-of-the-art performance on major tasks in drug research. Its considerable improvements indicate a promising paradigm of AI-based pipeline for drug development.

Recent advances in self-supervised learning enabled novel medical AI models, known as foundation models (FMs) that offer great potential for characterizing health from diverse biomedical data. Continuous glucose monitoring (CGM) provides rich, temporal data on glycemic patterns, but its full potential for predicting broader health outcomes remains underutilized. Here, we present GluFormer, a generative foundation model on biomedical temporal data based on a transformer architecture, and trained on over 10 million CGM measurements from 10,812 non-diabetic individuals. We tokenized the CGM training data and trained GluFormer using next token prediction in a generative, autoregressive manner. We demonstrate that GluFormer generalizes effectively to 15 different external datasets, including 4936 individuals across 5 different geographical regions, 6 different CGM devices, and several metabolic disorders, including normoglycemic, prediabetic, and diabetic populations, as well as those with gestational diabetes and obesity. GluFormer produces embeddings which outperform traditional CGM analysis tools, and achieves high Pearson correlations in predicting clinical parameters such as HbA1c, liver-related parameters, blood lipids, and sleep-related indices. Notably, GluFormer can also predict onset of future health outcomes even 4 years in advance. We also show that CGM embeddings from pre-intervention periods in Randomized Clinical Trials (RCTs) outperform other methods in predicting primary and secondary outcomes. When integrating dietary data into GluFormer, we show that the enhanced model can accurately generate CGM data based only on dietary intake data, simulate outcomes of dietary interventions, and predict individual responses to specific foods. Overall, we show that GluFormer accurately predicts health outcomes which generalize across different populations metabolic conditions.

For many people, sitting back in the dentist's chair can already be a terrifying experience. But now a trip to the dentist could get a whole lot scarier as an AI-powered robot completes its first unsupervised procedure on a live human. The robot, developed by US-based company Perspective, successfully carried out a crown replacement in just 15 minutes - eight times faster than a human specialist. To carry out the procedure, the patient's mouth was first mapped with a 3D scanner before an AI planned and carried out the operation autonomously. Dr Chris Ciriello, CEO and founder of Perceptive, says: 'This medical breakthrough enhances precision and efficiency of dental procedures, and democratizes access to better dental care, for improved patient experience and clinical outcomes.'