Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis.

BACKGROUND: The digital health sector has experienced rapid growth over the past decade. However, health care technology stakeholders lack a comprehensive understanding of clinical robustness and claims across the industry. OBJECTIVE: This analysis aimed to examine the clinical robustness and public claims made by digital health companies. METHODS: A cross-sectional observational analysis was conducted using company data from the Rock Health Digital Health Venture Funding Database, the US Food and Drug Administration, and the US National Library of Medicine. Companies were included if they sell products targeting the prevention, diagnosis, or treatment phases of the care continuum. Clinical robustness was defined using regulatory filings and clinical trials completed by each company. Public claims data included clinical, economic, and engagement claims regarding product outcomes made by each company on its website. RESULTS: A total of 224 digital health companies with an average age of 7.7 years were included in our cohort. Average clinical robustness was 2.5 (1.8 clinical trials and 0.8 regulatory filings) with a median score of 1. Ninety-eight (44%) companies had a clinical robustness score of 0, while 45 (20%) companies had a clinical robustness score of 5 or more. The average number of public claims was 1.3 (0.5 clinical, 0.4 economic, and 0.4 engagement); the median number of claims was 1. No correlation was observed between clinical robustness and number of clinical claims (r2=0.02), clinical robustness and total funding (r2=0.08), or clinical robustness and company age (r2=0.18). CONCLUSIONS: Many digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online. Companies and customers may benefit from investing in greater clinical validation efforts.

Recognizing synesthesia on the international stage: The first scientific symposium on synesthesia (at The International Conference of Physiological Psychology, Paris, 1889).

At the first ever worldwide international conference of psychology in Paris, 1889, one symposium included a round-table event devoted entirely to the neurodevelopmental condition of synesthesia. Details of this seminal gathering on synesthesia and its international reception have been lost to historical obscurity. A synesthesia study committee emerged from this meeting, as well as a new research tool. Moreover, the scientific findings discussed during this symposium would be echoed over a hundred years later, when a new wave of synesthesia research in the late-twentieth century arose. This article sheds new light on this seminal gathering and aims to answer the following historical questions: Why was synesthesia included in this conference? What science was discussed? Who were the members of the committee and how did they come to be involved? What were their contributions to synesthesia research before, during, and after the conference? What has history shown us about the impact of this symposium on the science of synesthesia?

The evolution of the concept of synesthesia in the nineteenth century as revealed through the history of its name.

Synesthesia is a rare perceptual condition causing unusual sensations, which are triggered by the stimulation of otherwise unrelated modalities (e.g., the sensation of colors triggered when listening to music). In addition to the name it takes today, the condition has had a wide variety of designations throughout its scientific history. These different names have also been accompanied by shifting boundaries in its definition, and the literature has undergone a considerable process of change in the development of a term for synesthesia, starting with "obscure feeling" in 1772, and ending with the first emergence of the true term "synesthesia" or "synæsthesiæ" in 1892. In this article, we will unpack the complex history of this nomenclature; provide key excerpts from central texts, in often hard-to-locate sources; and translate these early passages and terminologies into English.

Is Digital Health for Diabetes in an Investment Bubble?

An investment bubble occurs when there is a surge in asset prices that is not warranted by asset fundamentals because of irrationally exuberant market behavior. When prices rise to a level where no additional investors are willing to buy at the elevated price, then a massive sell-off typically occurs. Digital health investments represent approximately 10% of venture capital-backed startup investments, and diabetes digital health startups represent 4% of digital health investments. Attributes of a bubble indicate evidence for and against the current time period being in an investment bubble for digital health startups. After analyzing these attributes as well as the overall economy and the demand for healthcare products, we conclude that digital health startups and particularly digital health startups for diabetes are not in a bubble.

The "golden age" of synesthesia inquiry in the late nineteenth century (1876-1895).

Synesthesia is a rare neurological trait that causes unusual, often cross-sensory, experiences (e.g., seeing colors when listening to music). This article traces the history of synesthesia in the period 1876 to 1895. In this period, there was considerable debate over the nature of synesthesia, its causes, and how it should be named. The issue also attracted the leading thinkers of the time and, within a few years, the number of reported cases of synesthesia jumped from around ten to more than 100. For this reason, this period can be regarded as the "golden age" for synesthesia research in the nineteenth century. In this time, scientists debated whether synesthesia was a form of pathology or an alternative manifestation of intelligence. The differing roles of heredity and environment were contested, and there were several explanations proposed as to its neural basis. These enquiries went to the heart of the debate as to whether synesthetic experiences are special in any way or, instead, a more vivid manifestation of a more general capacity for forming associations.

Controlled cyclic compression of an open tibial fracture using an external fixator affects fracture healing in mice.

Fractures resulting in impaired healing can be treated with mechanical stimulation via external fixators. To examine the effect of mechanical stimulation on fracture healing, we developed an external fixator for use in a mouse model. A 0.5 mm tibial osteotomy was stabilized with the external fixator in C57BL/6 mice. Osteotomies in the treatment group (nt = 41) were subjected to daily sessions of 150 µm of controlled displacement with the aim to create a more mineralized callus at 21 days compared with the control group (nc = 39). Qualitative assessment of the histology found no notable difference in healing patterns between groups at 7, 12, 17, and 21 days. At 21 days, micro-computed tomography (CT) analysis showed that the control group had a significantly higher bone volume (BV) fraction and trabecular number compared with treatment; however there was no significant difference in the total volume (TV) of the callus or trabecular thickness between groups. In summary, the external fixator was used with a motion application system to apply controlled displacement to a healing fracture; however, this treatment did not result in a more mineralized callus at 21 days.

The development of a scientific understanding of synesthesia from early case studies (1849-1873).

The first case of synesthesia was reported in 1812 ( Jewanski, Day, & Ward, 2009 ). However, it took almost seven decades before the idea of synesthesia entered the mainstream of science and, subsequently, art. There are no known new cases described between 1812 and 1848, but in the following three decades there are at least 11 reported cases of synesthesia and many reviews of these cases. This comes at an important period in the history of the neurosciences, and for sensory physiology in particular. However, the literature that describes synesthesia during this period is largely unknown to contemporary researchers and historians. The aim of this review is to discuss the reports of synesthesia during this period, providing translations of some key passages, and to place these reports within the contextual framework of nineteenth-century neuroscience.

A colorful albino: the first documented case of synaesthesia, by Georg Tobias Ludwig Sachs in 1812.

In 1812, Georg Sachs published a medical dissertation concerning his own albinism and that of his sister. However, he also goes on to describe another phenomenon--namely synaesthesia involving colors for music and simple sequences (including numbers, days, and letters). Most contemporary researchers of synaesthesia fail to cite the case when offering a history of the subject and fewer still will have read it (the original was published in Latin). In this article, we argue that Sachs's case is the first convincing account of synaesthesia; we provide the first English translation of his description of it; we discuss the influence of the case in early theories about synaesthesia and its resonance with contemporary research findings.