FDA
Elon Musk's Neuralink should be disqualified from FDA approval, advocacy groups says
An advocacy group of more than 17,000 doctors has petitioned the Food and Drug Administration (FDA) to disqualify Elon Musk's Neuralink from receiving approval for its brain implant. The Physicians Committee for Responsible Medicine (PCRM) claims Neuralink has violated the'good laboratory practices' (GLP) regulations, which ensures the quality and integrity of non-clinical laboratory studies, with its'hack job' surgeries and staff'manipulating data.' Some of the animal's deaths were at the hands of Matthew McDougall, the head neurosurgeon, who administered nearly six times the amount of an unapproved'toxic' substance that led to a monkey's death, a former Neuralink employee told DailyMail.com. This was stated in messages written by John Morrison, the study director at the University of California, Davis (UC Davis), Merkley added. Elon Musk said his Neuralink is seeking FDA approval to start human trials, but a group is trying to block these efforts.
Principal-Agent Hypothesis Testing
Bates, Stephen, Jordan, Michael I., Sklar, Michael, Soloff, Jake A.
Consider the relationship between a regulator (the principal) and a pharmaceutical company (the agent). The pharmaceutical company wishes to sell a product to make a profit, and the FDA wishes to ensure that only efficacious drugs are released to the public. The efficacy of the drug is not known to the FDA, so the pharmaceutical company must run a costly trial to prove efficacy to the FDA. Critically, the statistical protocol used to establish efficacy affects the behavior of a strategic, self-interested pharmaceutical company; a lower standard of statistical evidence incentivizes the pharmaceutical company to run more trials for drugs that are less likely to be effective, since the drug may pass the trial by chance, resulting in large profits. The interaction between the statistical protocol and the incentives of the pharmaceutical company is crucial to understanding this system and designing protocols with high social utility. In this work, we discuss how the principal and agent can enter into a contract with payoffs based on statistical evidence. When there is stronger evidence for the quality of the product, the principal allows the agent to make a larger profit. We show how to design contracts that are robust to an agent's strategic actions, and derive the optimal contract in the presence of strategic behavior.
Good Machine Learning Practice for Medical Device Development: Guiding Principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. They use software algorithms to learn from real-world use and in some situations may use this information to improve the product's performance. But they also present unique considerations due to their complexity and the iterative and data-driven nature of their development.
Neuralink reportedly under investigation by US govt • The Register
Neuralink is reportedly being investigated by the US government for possibly mistreating animals in lab experiments as the company rushes to build an implantable brain chip. The startup, founded in 2016 by belligerent biz baron Elon Musk, is developing a medical device to help people afflicted with brain disorders to communicate, see, or move more easily. The Tesla tycoon said he wants to see the chips in humans next year. However, before Neuralink obtains permission to start conducting trials on humans from the Food and Drug Administration (FDA), it has to test the technology on animals to show it's safe enough for people to try. A lawsuit, filed in February by animal rights group the Physicians Committee for Responsible Medicine, accused the startup of killing monkeys after a series of sloppy surgical procedures to insert electrodes inside their skulls.
Ultromics secures FDA clearance for heart failure AI software
Ultromics has secured clearance from the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI)-based echocardiography software for the detection of heart failure with preserved ejection fraction (HFpEF). EchoGo Heart Failure uses AI to identify HFpEF from a single echocardiogram image, according to the firm. The clearance come just weeks after Ultromics joined the Foundation for the National Institutes of Health Accelerating Medicines Partnership Heart Failure program, which is a collaboration between the National Institutes of Health, the National Heart Lung and Blood Institute, the FDA, the American Heart Association, the American Society of Echocardiography, and industry, the company said.
Analysis of Drug repurposing Knowledge graphs for Covid-19
Knowledge graph (KG) is used to represent data in terms of entities and structural relations between the entities. This representation can be used to solve complex problems such as recommendation systems and question answering. In this study, a set of candidate drugs for COVID-19 are proposed by using Drug repurposing knowledge graph (DRKG). DRKG is a biological knowledge graph constructed using a vast amount of open source biomedical knowledge to understand the mechanism of compounds and the related biological functions. Node and relation embeddings are learned using knowledge graph embedding models and neural network and attention related models. Different models are used to get the node embedding by changing the objective of the model. These embeddings are later used to predict if a candidate drug is effective to treat a disease or how likely it is for a drug to bind to a protein associated to a disease which can be modelled as a link prediction task between two nodes. RESCAL performed the best on the test dataset in terms of MR, MRR and Hits@3.
Elon Musk's Neuralink 'botched experiments' revealed by former employee and internal lab notes
'Botched experiments' by Elon Musk's Neuralink allegedly'kept suffering animals alive for no reason and malpractice caused monkey's brains to hemorrhage' during rushed brain chip testing, a former Neuralink employee and internal lab notes reveal. The billionaire's startup is accused of violating the Animal Welfare Act with its experiments at the University of California, Davis, from 2017 through 2020, which'sacrificed all the animals involved,' a former Neuralink employee, who asked to remain anonymous, told DailyMail.com. One case stood out to them- a monkey sacrificed ahead of schedule due to errors allegedly made during surgery. 'There was no reason to use it,' the former employee, who worked as a necropsy technician, told DailyMail.com. 'BioGlue was not FDA-approved for brain surgery and would never be able to be carried over to human trials.
Elon Musk's Neuralink 'faces USDA investigation after deaths of 1,500 animals in testing'
Elon Musk's Neuralink is under federal investigation for animal-welfare violations amid staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to a Reuters review of documents and sources familiar with the investigation and company operations who spoke to Reuters. Neuralink, a medical devices company, is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments. The federal probe, which has not been previously reported, was opened in recent months by the U.S. Department of Agriculture's Inspector General at the request of a federal prosecutor, according to two sources with knowledge of the investigation. It comes amid growing employee dissent about Neuralink's animal testing, including complaints that pressure from CEO Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees. Elon Musk's Neuralink is facing a probe amid reports of botched animal testing according to Reuters In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company's animal-testing operations.
Elon Musk's Neuralink 'faces USDA investigation after deaths of 1,500 animals in testing'
Elon Musk's Neuralink is under federal investigation for animal-welfare violations amid staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to a Reuters review of documents and sources familiar with the investigation and company operations who spoke to Reuters. Neuralink, a medical devices company, is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments. The federal probe, which has not been previously reported, was opened in recent months by the U.S. Department of Agriculture's Inspector General at the request of a federal prosecutor, according to two sources with knowledge of the investigation. It comes amid growing employee dissent about Neuralink's animal testing, including complaints that pressure from CEO Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees. In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company's animal-testing operations.
Musk's Neuralink faces federal inquiry after killing 1,500 animals in testing
Elon Musk's Neuralink, a medical device company, is under federal investigation for potential animal-welfare violations amid internal staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to documents reviewed by Reuters and sources familiar with the investigation and company operations. Neuralink Corp is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments. The federal investigation, which has not been previously reported, was opened in recent months by the US Department of Agriculture's inspector general at the request of a federal prosecutor, according to two sources with knowledge of the investigation. The inquiry, one of the sources said, focuses on violations of the Animal Welfare Act, which governs how researchers treat and test some animals. The investigation has come at a time of growing employee dissent about Neuralink's animal testing, including complaints that pressure from Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees.