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  • ✇MIT Technology Review
  • Here’s the latest company planning for gene-edited babies Antonio Regalado
    A West Coast biotech entrepreneur says he’s secured $30 million to form a public-benefit company to study how to safely create genetically edited babies, marking the largest known investment into the taboo technology.   The new company, called Preventive, is being formed to research so-called “heritable genome editing,” in which the DNA of embryos would be modified by correcting harmful mutations or installing beneficial genes. The goal would be to prevent disease. Preventive was founded b
     

Here’s the latest company planning for gene-edited babies

1 November 2025 at 03:27

A West Coast biotech entrepreneur says he’s secured $30 million to form a public-benefit company to study how to safely create genetically edited babies, marking the largest known investment into the taboo technology.  

The new company, called Preventive, is being formed to research so-called “heritable genome editing,” in which the DNA of embryos would be modified by correcting harmful mutations or installing beneficial genes. The goal would be to prevent disease.

Preventive was founded by the gene-editing scientist Lucas Harrington, who described his plans yesterday in a blog post announcing the venture. Preventive, he said, will not rush to try out the technique but instead will dedicate itself “to rigorously researching whether heritable genome editing can be done safely and responsibly.”

Creating genetically edited humans remains controversial, and the first scientist to do it, in China, was imprisoned for three years. The procedure remains illegal in many countries, including the US, and doubts surround its usefulness as a form of medicine.

Still, as gene-editing technology races forward, the temptation to shape the future of the species may prove irresistible, particularly to entrepreneurs keen to put their stamp on the human condition. In theory, even small genetic tweaks could create people who never get heart disease or Alzheimer’s, and who would pass those traits on to their own offspring.

According to Harrington, if the technique proves safe, it “could become one of the most important health technologies of our time.” He has estimated that editing an embryo would cost only about $5,000 and believes regulations could change in the future. 

Preventive is the third US startup this year to say it is pursuing technology to produce gene-edited babies. The first, Bootstrap Bio, based in California, is reportedly seeking seed funding and has an interest in enhancing intelligence. Another, Manhattan Genomics, is also in the formation stage but has not announced funding yet.

As of now, none of these companies have significant staff or facilities, and they largely lack any credibility among mainstream gene-editing scientists. Reached by email, Fyodor Urnov, an expert in gene editing at the University of California, Berkeley, where Harrington studied, said he believes such ventures should not move forward.

Urnov has been a pointed critic of the concept of heritable genome editing, calling it dangerous, misguided, and a distraction from the real benefits of gene editing to treat adults and children. 

In his email, Urnov said the launch of still another venture into the area made him want to “howl with pain.”  

Harrinton’s venture was incorporated in Delaware in May 2025,under the name Preventive Medicine PBC. As a public-benefit corporation, it is organized to put its public mission above profits. “If our research shows [heritable genome editing] cannot be done safely, that conclusion is equally valuable to the scientific community and society,” Harrington wrote in his post.

Harrington is a cofounder of Mammoth Biosciences, a gene-editing company pursuing drugs for adults, and remains a board member there.

In recent months, Preventive has sought endorsements from leading figures in genome editing, but according to its post, it had secured only one—from Paula Amato, a fertility doctor at Oregon Health Sciences University, who said she had agreed to act as an advisor to the company.

Amato is a member of a US team that has researched embryo editing in the country since 2017, and she has promoted the technology as a way to increase IVF success. That could be the case if editing could correct abnormal embryos, making more available for use in trying to create a pregnancy.

It remains unclear where Preventive’s funding is coming from. Harrington said the $30 million was gathered from “private funders who share our commitment to pursuing this research responsibly.” But he declined to identify those investors other than SciFounders, a venture firm he runs with his personal and business partner Matt Krisiloff, the CEO of the biotech company Conception, which aims to create human eggs from stem cells.

That’s yet another technology that could change reproduction, if it works. Krisiloff is listed as a member of Preventive’s founding team.

The idea of edited babies has received growing attention from figures in the cryptocurrency business. These include Brian Armstrong, the billionaire founder of Coinbase, who has held a series of off-the-record dinners to discuss the technology (which Harrington attended). Armstrong previously argued that the “time is right” for a startup venture in the area.

Will Harborne, a crypto entrepreneur and partner at LongGame Ventures, says he’s “thrilled” to see Preventive launch. If the technology proves safe, he argues, “widespread adoption is inevitable,” calling its use a “societal obligation.”

Harborne’s fund has invested in Herasight, a company that uses genetic tests to rank IVF embryos for future IQ and other traits. That’s another hotly debated technology, but one that has already reached the market, since such testing isn’t strictly regulated. Some have begun to use the term “human enhancement companies” to refer to such ventures.

What’s still lacking is evidence that leading gene-editing specialists support these ventures. Preventive was unsuccessful in establishing a collaboration with at least one key research group, and Urnov says he had harsh words for Manhattan Genomics when that company reached out to him about working together. “I encourage you to stop,” he wrote back. “You will cause zero good and formidable harm.”

Harrington thinks Preventive could change such attitudes, if it shows that it is serious about doing responsible research. “Most scientists I speak with either accept embryo editing as inevitable or are enthusiastic about the potential but hesitate to voice these opinions publicly,” he told MIT Technology Review earlier this year. “Part of being more public about this is to encourage others in the field to discuss this instead of ignoring it.”

  • ✇STAT
  • STAT+: Insurers say they’ll deploy more AI to combat ‘aggressive’ coding by hospitals Katie Palmer
    Health insurance companies are fighting fire with fire as they combat rising medical costs they say are being driven up, in part, by artificial intelligence.  Large private insurers have continued to call out purportedly overzealous coding and billing as a source of ballooning health care costs. In particular, some have blamed the use of AI tools for some of the surge in claims from health care providers that have cut into their profits.  “I’ve talked to a couple of my peers where it does
     

STAT+: Insurers say they’ll deploy more AI to combat ‘aggressive’ coding by hospitals

31 October 2025 at 16:30

Health insurance companies are fighting fire with fire as they combat rising medical costs they say are being driven up, in part, by artificial intelligence. 

Large private insurers have continued to call out purportedly overzealous coding and billing as a source of ballooning health care costs. In particular, some have blamed the use of AI tools for some of the surge in claims from health care providers that have cut into their profits. 

“I’ve talked to a couple of my peers where it does seem like the hospitals have gotten better organized around the application of AI for coding than payers,” said Centene chief financial officer Andrew Asher at the Deutsche Bank Healthcare Summit last month. “But we’re going to catch up to that.”

Continue to STAT+ to read the full story…

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Animal models in tuberculosis metabolomics: a systematic review of current evidence and the road to translational relevance

Front Mol Biosci. 2025 Oct 15;12:1688882. doi: 10.3389/fmolb.2025.1688882. eCollection 2025.

ABSTRACT

BACKGROUND: Animal models are important for tuberculosis (TB) research, offering controlled settings to study disease mechanisms. However, their ability to replicate TB-induced metabolic responses in humans is uncertain. This systematic review evaluated the current use of animal models in metabolomics studies aimed at characterising active pulmonary TB.

METHODS: PubMed, Scopus, and Web of Science were systematically searched for metabolomics studies of pulmonary TB in humans and animal models, following PRISMA guidelines. Eligible studies were screened, and quality was assessed using QUDOMICS and STAIR tools. Data were synthesised by species, sample matrix, experimental design, and reported differential metabolites. Differential metabolite names were compared between species and subjected to pathway analysis in MetaboAnalyst 6.0.

RESULTS: Of the 80 eligible studies, nine involved animal models, predominantly mice. These models captured only 4.7% of human TB-associated differential metabolites, with the highest overlap (3.8%) in mouse lung tissue. Despite low concordance at metabolite level, conserved disruptions were observed in amino acid, glutathione, and one-carbon metabolism pathways. Interspecies variation was evident, influenced by host species, sample matrix, infection protocol, and analytical method.

CONCLUSION: Animal models partially replicated key metabolic features of human TB, particularly at the pathway level. However, variability across studies hampers current translational interpretation. Broader model use, standardised protocols, and integrated multi-platform omics approaches are needed to improve the relevance and comparability of animal models in TB metabolomics research.

PMID:41169614 | PMC:PMC12568366 | DOI:10.3389/fmolb.2025.1688882

Wearable Artificial Intelligence for Epilepsy: Scoping Review

Background: Epilepsy affects approximately 50 million people globally and imposes a substantial clinical and societal burden, requiring continuous and personalized monitoring for effective management. Wearable artificial intelligence (AI) technologies offer a promising solution by leveraging physiological signals and machine learning for seizure detection and prediction. While various approaches have been proposed, a comprehensive overview summarizing these advances and challenges is still needed. Objective: This review aims to comprehensively explore and map the existing literature on AI-driven wearable technologies for epilepsy, identifying device characteristics, AI methodologies, biosignal measurements, validation approaches, and research gaps. Methods: A scoping review was conducted following the PRISMA-ScR guidelines. A systematic search was performed across six electronic databases (Scopus, MEDLINE, EMBASE, ACM Digital Library, IEEE Xplore, and Google Scholar) to identify relevant studies published up to December 2023. We included studies that developed AI algorithms for epilepsy using non-invasive wearable devices (e.g., smartwatches, smart clothing) and excluded those using non-wearables or in-body devices. Eligible publication types included journal articles, conference papers, and dissertations. Study selection and data extraction were performed independently by six reviewers. The extracted data was synthesized narratively. Results: A total of 68 studies met the inclusion criteria. Research in this domain has increased significantly since 2021, with India, the United States, and China leading contributions. The studies examined both commercial (45.6%) and non-commercial (47.1%) wearable devices, with Empatica smart bands being the most frequently used. The primary biosignals monitored included activity measures (54.4%), cardiovascular metrics (45.6%), brain activity (35.3%), and electrodermal activity (33.8%). The most common AI models were support vector machines (42.6%), random forests (22.1%), and convolutional neural networks (16.2%). Most models focused on seizure detection (77.5%) compared to seizure prediction (22.5%), reflecting a research imbalance that suggests the need for further development in predictive analytics. Sensitivity (80.9%) was the most frequently reported performance metric, indicating a focus on identifying seizures; however, comprehensive clinical validation remains limited. Closed-source data predominated (64.7%), limiting the generalizability of findings. The most used validation methods were leave-one-out cross-validation (30.9%) and k-fold cross-validation (29.4%), while video-EEG served as the primary reference standard (42.6%). Conclusions: Wearable AI technologies show significant promise in epilepsy management, offering real-time, continuous monitoring and early seizure detection. To realize clinical impact, future research should prioritize the standardization of validation methods, promote open data exchange for reproducibility, and develop energy-efficient algorithms that support real-world deployment in wearable devices.

Digital Health Technology Compliance With Clinical Safety Standards In the National Health Service in England: National Cross-Sectional Study

Background: To be authorized for use in the National Health Service (NHS) in England, digital health technologies (DHTs) must meet 2 mandatory clinical risk management standards, Data Coordination Board (DCB) 0129 and 0160, demonstrating that risks from design and use have been assessed and mitigated. NHS organizations must not procure a DHT without DCB0129 assurance and must not deploy one without DCB0160 assurance. Despite legal requirement, no public data exist on how many DHTs are in use in the NHS or how many are assured. Objective: This study aimed to determine the number of DHTs in use in the NHS in England and assess their assurance status against mandated clinical safety standards. Methods: In early 2025, 239 NHS organizations in England received a freedom of information notice requesting information on the number of DHTs they were using and their assurance against DCB0129 and DCB0160 standards. Results: Of the 239 NHS organizations, 204 (85.4%) responded, of which 178 (87.3%) provided full or partial data, covering 14,747 DHT deployments. The mean number of deployed DHTs per organization was 82.8 (SD 146.1; 95% CI 61.4-104.3) with substantial variation between NHS provider trusts (mean 107.1, SD 161.1; 95% CI 79.8-134.3), ambulance trusts (mean 13.0, SD 8.2; 95% CI 7.6-18.4), and integrated care boards (mean 8.1, SD 16.0; 95% CI 2.8-13.5). Overall organizational compliance rates were low, with a median of 25.6% (IQR 7.8%-55.7%) deployed DHTs being fully assured; for NHS provider trusts compliance was lower at 24.5% (IQR 8.1%-50%). A total of 13 (6.4%) of the 204 organizations reported that all their DHTs were fully assured, while 16 (7.8%) reported that none were assured. Across all DHTs with reported assurance data, 17.3% (95% CI 16.6%-18.1%) were fully assured against both standards, 13.3% were partially assured against one standard, and 70.1% (95% CI 69.1%-71.1%) had no documented assurance. Conclusions: This is the first study to quantify both the scale of DHT deployment in NHS organizations in England and the extent of compliance with mandatory safety standards. More than 10,000 DHTs currently in use lack documented assurance against clinical safety standards. In a typical NHS trust, 3 out of 4 digital tools influencing patient care do not demonstrate compliance with minimum legal or clinical safety requirements. These findings raise significant concerns about the risks posed to patients by these technologies; the capacity of organizations to assess and mitigate them; and the legal ramifications of when, not if, harm occurs. Crucially, failure to assure digital technologies poses a significant risk to one of the core ambitions of the NHS 10-Year Health Plan for England; safely transitioning from analogue to digital care models. These findings are unlikely to be unique to the NHS and should prompt health care systems worldwide to assess the risks posed by their DHT deployments.

Opportunities and Challenges for Designing in Connected Health: Insights From an Expert Workshop

Health care increasingly depends on information and communication technology. This offers both opportunities and challenges when designing connected health systems. While individual studies examined particular cases, there is a limited synthesis of insights across projects. The objective of this paper is to explore these opportunities and challenges by examining 6 diverse connected health projects and synthesizing lessons from an expert workshop. To achieve this, we conducted a full-day workshop that brought together 6 connected health projects. The workshop used an iterative and participatory process which included paper submissions and presentations and facilitated discussions, and a gallery walk to enable cross-case comparison and collaborative reflection. Thematic analysis of workshop outputs was then used to synthesize key opportunities and challenges in designing connected health systems. The 6 projects represented a variety of design methods and approaches to connected health, and their discussion surfaced both opportunities and challenges in this domain. Key opportunities include improving data integration and usability, enhancing collaboration across stakeholders, using a user-centered and iterative design process, addressing complexity in sociotechnical systems, sustainability, and adopting digital infrastructures for seamless communication. Participants also identified important challenges, namely exchange of information, interoperability, and communication; ethical considerations, rules, and regulations; understanding design, evaluation, and standards; actionable data, reliability, quality, and trust in data; and stakeholder involvement. The contribution of this paper lies in the synthesis of insights across multiple projects and perspectives to provide practical guidance for researchers, designers, and policymakers. By highlighting opportunities and challenges in designing connected health systems, the findings emphasize the importance of patient-centered, sustainable, and collaborative design approaches while also pointing to the need to address persistent barriers. Advancing connected health will require adopting iterative and inclusive design processes that prioritize patient-centeredness, sustainability, and collaboration across health care systems.
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