AI technology impacts gynaecological ultrasound by detecting preterm birth

When applied to real-world data in a clinical context, PAI has shown predictive values of over 90% while predicting preterm and normal births, GlobalData reports.

On 29 March, International Women’s Day, Ultrasound AI Inc announced that it had been awarded its first patent for its newest predictive diagnostic tool, Preterm AI (PAI). Ultrasound AI is a Cloud-based artificial intelligence (AI) company that provides ultrasound imaging, and is headquartered in Highlands Ranch, Colorado, US. PAI combines ultrasound technology with AI to predict preterm birth, allowing for earlier interventions.

When applied to real-world data in a clinical context, PAI has been able to show predictive values of over 90% when predicting preterm and normal births.

Preterm Birth (PTB) is a major, long-lasting public health problem. It is the leading cause of mortality and long-term disabilities among neonates and has heavy emotional and financial consequences for families and society. The prediction of PTB risk has been an exceedingly challenging problem for first-time mothers (nulliparous women) due to the lack of prior pregnancy history.

Over $26 billion is spent annually on the delivery and care of 12% of infants who are born preterm in the US. One crucial challenge for this space is to identify women who are at the highest risk for early preterm birth and to develop interventions that address this risk. The ability to identify women who are at the lowest risk for preterm birth is equally important to avoid unnecessary and costly interventions. PAI provides a potential solution to both problems by detecting the risk of preterm birth in women who may or may not have any known risk factors, and alert physicians to prevent a preterm birth by introducing interventions early on.

05/22/2024 23:28:12

Regulation

FDA warns of false results in genetic non-invasive prenatal testing

Neither the accuracy nor the efficacy of non-invasive prenatal testing (NIPT) has been authorised, cleared or approved by the FDA, GlobalData reports.

Congenital abnormalities are the leading cause of infant mortality worldwide; therefore, the use of prenatal screening in developed countries is common to detect chromosomal abnormalities and neural tube defects. The US Food and Drug Administration (FDA) recently issued a safety communications article informing healthcare professionals and patients of the dangers associated with genetic non-invasive prenatal testing (NIPT) or screening (NIPS) tests.

NIPTs highlight the possible risk of a foetus having certain genetic abnormalities by analysing small fragments of fetal DNA found in blood drawn from a pregnant person. While NIPTs are often used by healthcare professionals, neither their accuracy nor their efficacy has been authorised, cleared or approved by the FDA.

Importantly, there have been reports where pregnancies have been terminated due to false results indicating genetic abnormalities based on the results of NIPTs alone. Since NIPS are not definitive in nature, as they only tell the potential risk of the foetus having a genetic disorder, it is important to pair their test results with a diagnostic test.

The prenatal screening market is estimated to reach $1.65bn by 2030 at a negative compound annual growth rate (CAGR) of 2.1%. Since the FDA is encouraging increased vigilance in using NIPTs, GlobalData predicts a greater decrease in the NIPT market, as healthcare professionals and patients practice caution, and an increase in market share by other competing laboratory-based tests. There may, potentially, be an increase in prenatal diagnostic testing such as foetal echocardiograms and foetal blood sampling, as healthcare professionals pair these with NIPTs. Although these false negatives have been addressed only by the FDA, the US is the largest consumer of NIPTs and will thus reflect an overall decline in the NIPT market.

Main image: JHVEPhoto / Shutterstock.com

05/23/2024 04:00:51

COMPANY INSIGHT

Embedded Technology for Medical Applications – Meeting the Standards

Providers of electronic components, embedded displays, monitors and PCs for medical systems must be familiar with the specific requirements and standards which apply to medical equipment, as well as the particular challenges posed by obsolescence.

At Solid State, we offer both off-the-shelf and customised technology solutions for medical applications.

Embedded Technology for Medical Applications

Medical technology plays a vital role in the diagnosis, treatment and monitoring of patients, and increasingly in the prevention of disease and other conditions through early detection and self care.

There are very specific requirements and demands on the electronic components and displays employed in medical systems. The EN 60601 group of standards covers the safety, essential performance and electromagnetic compatibility of all medical electrical and electronic equipment, which must be suitable for the appropriate clinical and medical environments. It’s important that providers of components and displays are familiar with these demands and understand how OEMs are impacted.

The team at Solid State has years of experience of supplying top tier medical OEMs and is well aware of the hoops they must jump through. We have also helped to overcome the significant problems that can arise from the obsolescence of a component or display, drawing on both our off-the-shelf portfolio and our Custom Solutions Centre to provide alternatives. We adopt a consultative approach – we’ll listen to what you are trying to achieve and help to find the best possible solution. As a technical, franchised distributor of components and displays, we are committed to adding genuine value to the supply chain, going far beyond traditional distribution to offer good technical support and also providing a host of Value-Added Services.

Displays, embedded processing solutions, lighting, imaging and communication technology are all widely used in medical applications. Our applications specialists for each area can guide you through the pros and cons of available solutions and help you make the best choice for your requirements.

The Stringent Requirements of High End Medical Diagnostic Imaging

To cite just one example - Panel PCs and display monitors used for high end medical diagnostic imaging will need to be compliant with DIN 6868-157 standards for maximum ambient light levels, and a DICOM calibrated display for diagnosis is also strongly recommended. We therefore offer a range of medical panel PCs designed to meet these requirements, and suitable for use in any medical environment, including operating room, intensive care unit, examination room and preoperative preparation room.

Compliant with DICOM and DIN 6868-157 standards, our medical Panel PCs can be used for examining medical images including X-ray, ultrasound, MRI, angiography and CT scan, providing accurate DICOM grayscale standard display and images of highest clarity, and capable of operating all-day operation with battery swapping.

The antibacterial outer shell of these PCs effectively reduces risk of infection. Their full flat front panel is IP65 water- and dust-resistant, which provides greater ease of cleaning and maintenance, and can be cleansed and disinfected with alcohol. Healthcare personnel are able to operate the touch screen wearing gloves, preventing the spread of infection by contact.

Our medical-grade MX/MD-series LED-backlit monitors are also designed for durability and ease of cleaning in medical and clinical environments. Featuring full HD resolution and EN/IEC 60601-1 standard and DICOM Part 14 specification compliance, they offer wide viewing angles.

LEDs, Light Sources and Sensors

Solid State Supplies can also help with the illumination and sensing requirements of medical equipment. Our compact, pulsed xenon flash lamps are particularly of interest to product designers and engineers developing small form factor analytical systems for point of care and field use applications such as medical analytics.

Our LED specialists can advise on the specific wavelengths which may be required for phototherapy, and we offer both low and high power UV and IR LEDs. Many of our optical sensors are used in medical instrumentation, and we have helped OEMs facing obsolescence by producing alternative equivalent devices via our UK-based Custom Solutions Centre.

Overcoming Obsolescence Challenges

Obsolescence can cause major problems for medical technology providers. In highly complex and expensive equipment, the entire system has to be taken into consideration when replacing a part, to ensure stringent requirements and regulations continue to be met.

Our medical customers have faced significant challenges when, for example, production of vital optoelectronic sensors or medical display panels has been discontinued. In this situation, replacement products must be sourced that are ‘like for like’ both mechanically and electronically, to avoid lengthy and costly re-verification and re-validation processes. Finding replacement parts through a new partner may be preferable to investing in a large last-time-buy of stock that could degrade and become unusable.

Helping to overcome obsolescence challenges is a particular focus for Solid State Supplies. Our specialist SOS business unit offers a comprehensive sourcing service for obsolete and hard-to-find electronic components. Utilising the latest anti-counterfeit detection methods, and with over 20 years of industry knowledge, SOS is an assured source for obsolescence requirements.

In addition, our Custom Solutions Centre has the resources and capabilities to design and build completely new components and displays to replace obsolete parts.

Contact information

Solid State Supplies

+44 (0) 1527 830800

sales@sssltd.com

Address: Ravensbank Business Park,

Hedera Road, Redditch, B98 9EY

www.sssltd.com

05/23/2024 04:00:51