Latest news: artificial intelligence in medical devices

UltraSight has secured approval from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-based cardiac ultrasound guidance technology. With real-time AI guidance software, medical professionals having no sonography experience can acquire cardiac ultrasound images right at the point of care in various settings. 

The software is intended for two-dimensional transthoracic echocardiography (2D-TTE) in adult patients, particularly to capture the ten standard views of the heart. 
 Compatible with the Philips Lumify Ultrasound System, the software can be utilised as an accessory for point-of-care ultrasound systems. 

When used along with a compatible device, the AI neural network of UltraSight is designed to predict the position of the ultrasound probe in relation to the heart, based on the ultrasound video stream.   

UltraSight CEO Davidi Vortman said: “The need to solve this significant disparity is why we applied deep geometrical machine-learning techniques to cardiac ultrasound and what we found is that AI has the potential to close the skillset gap – empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. 

“With FDA clearance, we can now move forward with bringing our innovation to market and ultimately advancing patient care for the millions in need.” 

Amid rising levels of artificial intelligence (AI) use and application, the European Medicines Agency (EMA) has issued a draft paper outlining its view on the use of AI and machine learning (ML) in various stages of a medicine’s life cycle.  

The paper, a part of a joint Human Medicines Agency (HMA)-EMA initiative to develop data-driven regulation, highlights the promise that AI/ML capabilities can bring to all steps of a medicine’s life cycle but warns of measures that should be taken by companies to ensure its legal and ethical use.  

The European Union (EU) has already drafted an AI law, in what will be the world’s first comprehensive law for the technology. And while regulations certainly exist for AI use in medical devices, the pharmaceutical industry lies in more of a grey zone.  

AI and ML tools can be extremely useful in the medicinal product life cycle. AI platforms can be used in the drug discovery process, and modelling approaches can be employed, which would change the use of animal models in preclinical development. The harnessing of data by AI/ML in clinical trials is already in use, and AI/ML can even be used at the market-authorisation and post-authorisation stages to help with product information compilation and pharmacovigilance activities.  

The paper outlines that companies using AI/ML at any stage of a medicine’s life cycle should be wary of existing legal frameworks and consider limitations or challenges that using the technology might have. These include issues around bias, overfitting, and data protection. An overarching theme of the paper is that companies using AI should always interact with regulators and operate within a “risk-based approach”. 

The EMA was keen to state that it is not within its remit to regulate AI/ML software used in medical devices. However, it did add that when using CE-marked devices in a clinical trial, additional requirements might need to be checked off to ensure the integrity of data and results, along with the safety of subjects.  

US-based TytoCare has raised $49m in growth funding, bringing the virtual care company’s total to $205m. 

Software investor Insight Partners joined the round, which included participation from Californian healthcare system Memorial Care, along with two pension funds. 

TytoCare has developed a device that allows doctors to remotely conduct examinations of patients. The FDA-cleared system, called Home Smart Clinic, includes functionality for remote physical exams such as listening to heart and lung sounds, measuring temperatures, and blood pressure and oxygen levels. The remote clinic incorporates the company’s artificial intelligence (AI) software to provide diagnosis support. 

In a statement announcing the deal, TytoCare said it will use the funds to explore further uses of its AI in diagnostic support and remote examination assistance, focusing particularly on conditions that need more than acute care visits. 

In March, the company already added an asthma module for its Tyto Insights software that expands the Home Smart Clinic’s application. A study investigating the health economics of the system, with results published in the Journal of Health Economics, found an overall saving of 7% in costs compared to normal care. 

A market report by GlobalData predicts that the global telehealth market (which includes all forms of virtual care) will increase fivefold from $690m in 2015 to $3.8bn by 2030. TytoCare co-founder and CEO Dedi Gilad said: “Virtual care has shown great promise, but audio-video options still fail to deliver the value of a doctor’s appointment and ultimately earn the trust of patients. 

“As TytoCare continues to grow, we hope to help more people experience clinic-quality care from home and help unlock the potential of remote care.” 

MemorialCare’s president and CEO Barry Arbuckle said: “TytoCare is defining the next generation of healthcare by recognising that healthcare happens more and more outside the four walls of a clinic.”