The U.S. FDA  has authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help healthcare providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.

“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The Centers for Disease Control and Prevention defines ASD as a “developmental disability that can cause significant social, communication and behavioral challenges” and is estimated to affect about 1 in 54 children. Because ASD symptoms can vary greatly, the disorder may be difficult to diagnose. While ASD may be detected as early as 18 months old, many children are not diagnosed until later in childhood, which can delay treatment and early intervention. The average age of diagnosis for ASD is 4.3 years. Some delays in diagnosis are due to the need for children to be referred to specialists with expertise in ASD.

Software as a medical device

The Cognoa ASD Diagnosis Aid is a software as a medical device that uses a machine learning algorithm to receive input from parents or caregivers, video analysts and health care providers to assist physicians evaluate a patient at risk of ASD. The device consists of three main components: a mobile app for caregivers and parents to answer questions about behaviour problems and to upload videos of their child; a video analysis portal that allows manufacturer-trained and certified specialists to view and analyse uploaded videos of patients; and a health care provider portal that is intended for a health care provider to enter answers to pre-loaded questions about behaviour problems, track the information provided by parents or caregivers and review a report of the results. After processing the information provided by parents, caregivers and healthcare providers, the ASD Diagnosis Aid reports a positive or negative diagnosis if there is sufficient information for its algorithm to make a diagnosis. If there is insufficient information to render a “Positive for ASD” or “Negative for ASD” result to help determine a diagnosis, the ASD Diagnosis Aid will report that no result can be generated.

Effectiveness of Cognoa ASD Diagnosis Aid

The FDA assessed the safety and effectiveness of the Cognoa ASD Diagnosis Aid in a study of 425 patients aged 18 months through 5 years in 14 different clinical care sites, with an average age of 2.8 years. The study compared the assessments made by the device directly against the assessments made by a panel of clinical experts who used the current standard ASD diagnostic process. The device provided a “Positive for ASD” or “Negative for ASD” result to aid in making a diagnosis in 32% of patients. For those with a “Positive for ASD” or “Negative for ASD” result, the device results matched the panel’s conclusions for 81% of patients who tested positive for ASD by the device and 98% of patients who tested negative for ASD by the device. In addition, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

The risks associated with the use of the device include misdiagnosis and delayed diagnosis of ASD, based on a false positive result (observed in 15 out of 303 study subjects without ASD), a false negative result (observed in one out of 122 study subjects with ASD) or when no result was generated. Both misdiagnosis or missed diagnosis can result in delayed treatment of ASD and delivery of treatment not appropriate for ASD.

The FDA reviewed the Cognoa ASD Diagnosis Aid through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The Cognoa ASD Diagnosis Aid is indicated as an aid in the diagnosis of ASD for patients 18 months through 5 years of age who are at risk of developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not indicated for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.

• For more information, visit: https://cognoa.com/

German company OR Technology has released their versatile Amadeo R motorised X-ray system, expanding their product range for the inpatient sector.

The X-ray system, consisting of a bucky table and grid wall stand, has an auto-tracking function suitable for all X-ray exposures in sitting, lying and standing positions.

An intuitive 10″ touchscreen display simplifies operation. Up to 60 pre-set positions of stand height, alignment and SID (Source-Image Distance) speed up the alignment of the unit.

The X-ray tube and bucky tray of the grid wall stand are designed to be lowered to the floor. The X-ray tube automatically follows the bucky tray of the wall stand as long as the column stand is not above the X-ray table. The X-ray table with six-position height-adjustable table top has a high load-bearing capacity. An armrest is attached to the grid drawer of the wall stand to provide support for patients during taxing exposures.

The company says X-ray staff quickly become familiar with the use of the acquisition and reporting software dicomPACS®DX-R.

A wide range of standard features such as motorised auto-tracking, the wireless three-way foot switch for all motorised functions, the integrated safety functions or the removable grid on the table or grid wall stand enable fast and efficient work in daily routine operation.

OR Technology, based in Rostock, Germany, has been a manufacturer of digital X-ray technology and developer of image management systems since 1991. The company’s own solutions are successfully used in practices and clinics in more than 120 countries. Their portfolio ranges from DR retrofits for existing stationary or mobile X-ray systems, to imaging plate systems (X-ray with cassettes), complete X-ray systems and mobile DR detector case solutions for outdoor use.

• For more information, visit: or-technology.com

Disinfection with high-energy UV-C light has been proven safe and effective. UV Smart makes this technology easily applicable for the validated disinfection of medical instruments and equipment. The result: a safer environment for healthcare professionals and their patients.

The Carestream DRX-Compass X-ray System

Carestream Health is providing healthcare facilities with a new floor-mount option for the DRX-Compass X-ray System. This option delivers an innovative, flexible and efficient medical imaging solution to sites that are unable to accommodate an overhead tube crane.

It is ideal for community, rural and private hospitals. It is also well suited for urgent care centers, orthopaedic and large radiology practices.

A good option for smaller budgets

“The free-standing tube mount eliminates the need for ceiling rails, but still provides the wall stand, table and console features, the same as the overhead tube crane,” said Jing Chu, Worldwide Product Marketing Manager at Carestream.

“This option will offer smaller facilities or sites with tighter budgets the ability to use the DRX-Compass and put Carestream’s exceptional image capture and processing to work.”

Advanced features

The Carestream DRX-Compass X-ray System (see video of DRX-Compass system) is an upgrade-friendly unit with a broad array of advanced features and options to meet changing needs. It has vertical auto-tracking and auto-centring, as well as an optional tilting wall stand to support a wide range of exams. Developed for easy positioning, this system was designed to decrease set-up time and increase throughput for every facility. Its intuitive, graphical user interface reduces training time for radiographers and allows for a secure, swipe-and-go login. The auto long-length imaging option is especially useful for patients who have trouble standing or young children who are unable to hold still for long periods of time.

“Whatever your modality right now, and wherever you need to go in the future, we have the upgrade strategy to get you there – seamlessly,” Chu said. “The DRX-Compass is designed to keep costs in line with a facility’s needs by being scalable and upgradable.”

Bridge to move from analogue to digital

With the ability to select components for specific locations, the system can easily adapt to space requirements. The DRX-Compass offers a bridge for healthcare facilities looking to move from an analogue or retrofitted X-ray room to a digital system. Through Carestream’s ImageView clinical acquisition software, powered by Eclipse image processing, healthcare facilities can add capabilities to their DRX-Compass systems as needed over time.

• For more info, visit www.carestream.com

Hologic has made available in Europe 3D ultrasound imaging on the SuperSonic MACH 30 and 20 ultrasound systems. This innovation gives clinicians access to high-resolution B-mode and ShearWave PLUS elastography 3D volumes, providing additional insights and enhancing diagnostic certainty.