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.
Greiner Bio-One’s has recently released MiniCollect® PIXIE – a safety lancet for the heel which is ideal for premature and newborn babies. With a shallow penetration depth, PIXIE nevertheless gently ensures maximum blood flow.
For bedridden individuals, everything revolves around the correct resting position in the bed. The position must be adjusted to match each individual patient and their physical condition. This means the patient’s position in the bed must be changed regularly to take pressure off of areas of the patient’s body and to prevent pressure sores.
Siemens Healthineers has received CE Mark for the AcuNav Volume ICE (Intracardiac Echocardiography) catheter, which is a therapyenabling imaging guide that provides realtime, wide-angle visualization of heart anatomy during Structural Heart and Electrophysiology procedures. AcuNav Volume ICE is the market’s first Volume ICE catheter.
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.
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.
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.
Objective testing demonstrated that SNC processing enables a 2X to 4X noise reduction in flat areas, preserves high frequency sharpness, and improves contrast detail.
Carestream Health has released Smart Noise Cancellation (SNC), a groundbreaking artificial intelligence (AI)-based technology that significantly improves image quality – producing images that are clearer than with standard processing. SNC has received FDA 510(k) Clearance and is available as an optional feature with Carestream’s ImageView Software powered by Eclipse – the intelligent image-processing engine behind the company’s innovative imaging software – on DRX-Evolution and DRX-Evolution Plus systems.
“Carestream is a leader in using AI for noise cancellation with X-ray images. Our team of imaging scientists has been able to separate image noise from sharpness and contrast using AI-based algorithms that result in remarkable image quality,” said Jill Hamman, Worldwide Marketing Manager, Global X-ray Solutions at Carestream. “This technology provides improved anatomical clarity, preservation of fine detail and better contrast-to-noise ratio for images acquired at a broad range of exposures, which can help improve diagnostic confidence and alleviate physician fatigue. It also enables radiology professionals to better optimize radiation dose.” Optimizing radiation dose is especially important with neonatal and paediatric diagnostic imaging, where imaging at the lowest possible dose is crucial for young patients.
Separating noise from an image has been a challenge for medical imaging scientists. Traditional noise reduction introduces blurring, which degrades image sharpness and might remove important anatomical information. Conversely, the more an image is sharpened, the more noise may be enhanced. Noise is often an undesirable by-product of image capture and can obscure critical anatomical data. Carestream’s SNC is able to isolate noise to produce images that are significantly clearer than with standard processing.
As the preferred level of noise on X-ray images is subjective – for example, some radiologists expect to see a certain degree of noise in images, which assures them that the patient was not overexposed – Carestream enables imaging professionals to adjust the amount of noise cancellation and exposure to meet their desired image quality.
In a blinded Clinical Reader study, 89.5% of all study ratings showed a slight to strong preference for SNC processed images.
Objective testing demonstrated that SNC processing enables a 2x–4x noise reduction in flat image areas, preserves high frequency sharpness and improves contrast detail. Additionally, a blind Clinical Reader Study using board-certified radiologists found that 89.5% of all study ratings showed a slight to strong preference for SNC-processed images. Sixty-four percent of the diagnostic quality ratings improved – based on the RadLex rating scale – and 56% of these ratings improved from “limited” or “diagnostic” to “exemplary”.
When combined with SmartGrid software, Smart Noise Cancellation software promises benefits in gridless imaging where the removal of scatter typically leads to an increase in noise appearance.
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.
The needle-free extension line with triple valve. photo: ©medK GmbH
medK, a German company specialising in interventional products, has launched a needle-free solution for vascular access. The needle-free connection offers secure and fast access to fluid lines eliminating the risk of needle sticks. The extension line can also be connected with a glass syringe. With the multi-way versions there is no need to use a stopcock or a manifold.
medK Needle free Extension Lines are compatible with disinfection with IPA wipes (Isopropanol). This and the smooth valve surface allows easy disinfection and reduces the risk of infections. The leak free disconnection protects against blood contaminations for health workers. Once disconnected it provides reliable closure and can stay up to seven days or two hundred activations with the patient. The fully visible flow path allows visual checking of the fluid.
The needle-free extension line valve. Photo: ©medK GmbH
The needle-free extension lines are also available with a combined check valve that safeguards against back tracking. The needle-free extension lines are compatible with Isopropanol, Chlorohexidine, blood and lipids. The device is suitable for use in MRI procedures and is latex and animal product free.
medK extension lines are available as single, dual and triple access with needle free or combined check valve.
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.
MiniCollect® PIXIE is a safety lancet for the heel designed to enhance safety during capillary blood collection from the heel of the youngest patients. With a shallow penetration depth, PIXIE nevertheless gently ensures maximum blood flow. This product is ideal for premature and new-born babies. Three different PIXIE safety lancets are available for heel incision, each adapted to a different stage of infant development. The depth of penetration and the length of incision differ depending on the selected device. Thanks to optimal ergonomics and the fully enclosed blade, MiniCollect PIXIE can enhance safety during capillary blood collection.
When MiniCollect PIXIE is positioned on the heel, the dual colour design, together with the arrows on both sides, allow a precise identification of the puncture site.
MiniCollect offers a gentle way to collect small blood samples for analyses.
The system is perfectly suited for young children, geriatric patients as well as patients with fragile veins. MiniCollect is also recommended in situations where venous blood collection proves particularly difficult or contraindicated.
For delicate vein conditions, patients who often have blood samples taken, or people with severe burns, capillary blood collection with the MiniCollect system offers a great alternative to venous blood collection.
The MiniCollect tube includes an integrated scoop, allowing droplets of blood to be collected easily and hygienically. To ensure that the puncture wound can be kept as small as possible while achieving the targeted sample volume there are different lancets with a wide range of puncture depths and blade sizes / needle gauges available.
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