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Archive for category: Product News

Products News

Lumen-i

Smartbox launches Lumin-i, a new eye tracking solution to assist people with disabilities to communicate

, 22 July 2021/in Product News /by panglobal

Smartbox Lumen-i

Lumin-i, a unique and advanced eye tracking product has been developed to assist people with disabilities to communicate without barriers. Lumin-i was launched globally on July 19, 2021.

The device was developed from a collaboration between Global Augmentative and Alternative Communication (AAC) provider Smartbox Assistive Technology, and Smart Eye, a leader in AI-based eye tracking solutions for the automotive, aerospace, neuroscience, and research sectors.

The collaboration combines Smartbox’s 15 years of experience in designing and delivering software, content, and hardware to a wide range of global AAC users and Smart Eye’s extensive expertise in designing and delivering eye tracking systems that respond to human behaviour. This collaboration means that Lumin-i is now offered as part of Smartbox’s market leading Grid Pad AAC devices [1].

Lumin-i features Smart Eye’s robust eye tracking algorithms, offering a high level of accuracy and enabling a very responsive solution. The technology has also been developed to work outdoors, allowing Lumin-i users to access their communication device anywhere.

It takes just 25 ms (milliseconds) for Lumin-i to respond to your gaze, capturing 60 frames per second with a gaze recovery time of just 17 ms. Lumin-i also has a large track box measuring 35 X 30 X 65 cm– which allows for lots of head movement – giving users with complex mobility needs a reliable and powerful solution for communication and independence.

Dougal Hawes, MD at Smartbox Assistive Technology said: “For the past 15 years eye gaze has been a crucial technology to Smartbox and our users. This collaboration with Smart Eye was born out of our desire to bring the world’s best eye tracking performance to our sector, giving people a highly accurate eye tracker that will work both indoors and outdoors.”

He added: “We always strive to offer our users the best possible solution and with Lumin-i we are able to provide a robust and quick-to-respond eye gaze solution that is made possible by Smart Eye’s years of experience in delivering quality eye tracking devices to some interesting customers including NASA, Airbus, Audi, Harvard University and Georgia Tech.”

Solmaz Shahmehr, Vice President & Head of Research Instruments at Smart Eye also commented: “We are very excited to be stepping into a market that is new to us, but at the same time resonates so well with Smart Eye’s core mission. Our goal has always been to bridge the gap between human and machine, and this partnership is an important step on the way. Through Lumin-i, our technology is giving people with disabilities a tool to communicate without barriers.”

  • For more information, visit: https://thinksmartbox.com/product/lumin-i/

[1] Smartbox communication aids are powered by Grid – market leading text and symbol-based software which offers users a voice, environmental control, and access to a range of grid sets and accessible apps supporting children and adults with complex disability and communication needs.

https://interhospi.com/wp-content/uploads/sites/3/2021/07/lumin-i.png 1138 1656 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2021-07-22 08:46:402021-07-22 08:46:40Smartbox launches Lumin-i, a new eye tracking solution to assist people with disabilities to communicate
Lumenis

Lumenis surgical lasers used in all hospitals on U.S. News & World Report Best Hospitals Honor Roll

, 22 July 2021/in Product News /by panglobal

Lumenis

Lumenis, a medical device company renowned for developing and commercializing innovative energy-based technologies, including laser, intense pulsed light (IPL) and radio frequency (RF), for surgical, aesthetic, and ophthalmic applications, notes that all the hospitals named to U.S. News and World Report’s Best Hospitals Honor Roll use Lumenis surgical lasers. Most of them use the company’s flagship products: Lumenis MOSES holmium laser technology and the pioneering Lumenis UltraPulse DUO CO2 surgical laser system.

The Lumenis holmium laser with MOSES technology delivers many clinical and economic advantages for kidney stones [1] and enlarged prostate [2] – two common procedures in many hospitals. Nearly universal adoption among these 20 top hospitals shows the strong trend toward standardization to MOSES technology. With MOSES, surgeons ablate stones with up to 85% higher efficiency [3] and 20% shorter procedure times [1].

For enlarged prostate surgery, MOSES has turned gold-standard HoLEP surgery from an overnight stay into a same-day, catheter-free discharge, [4] creating a better patient experience while freeing  hospital beds for acute care. Similarly, the tissue-sparing precision of the UltraPulse DUO CO2 laser has revolutionized challenging procedures, such as transoral microsurgery and minimally invasive treatment of uterine fibroids and endometriosis. Lumenis lasers offer multi-specialty flexibility in busy medical centres, with applications in urology, gynaecology, otolaryngology, neurology and orthopaedics.

“We are pleased to see every one of the outstanding hospitals on the Best Hospitals Honor Roll uses Lumenis surgical lasers,” said Tzipi Ozer-Armon, CEO, Lumenis. “At Lumenis, our mission is to deliver better technology for better patient care. We believe that one way to achieve this is through innovation and collaboration with leading surgeons and hospitals around the world. The end result is that Lumenis technologies are helping exceptional hospitals deliver exceptional patient care.”

References

1. Ibrahim A et al. Double-Blinded Prospective Randomized Clinical Trial Comparing Regular and MOSES Modes of Holmium Laser Lithotripsy. J Endourology. 2020;34(5):624-628.

2. Kavoussi NL et al. MOSES Technology for Holmium Laser Enucleation of the Prostate: A Prospective Double-Blind Randomized Control Trial. J Urol. 2021 Feb 22.

3. Bench test results may not necessarily be indicative of clinical performance.

4. Agarwal DK et al. Same Day Discharge is a Successful Approach for the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2021 Jan 4;S2405-4569(20)30320-5.

 

  • For more information, visit lumenis.com.
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dexcom

FDA clears Dexcom real-time diabetes monitoring APIs for third-party Apps and devices

, 22 July 2021/in Product News /by panglobal

dexcom

DexCom, a global leader in real-time continuous glucose monitoring for people with diabetes, has received US FDA clearance of the Dexcom Partner Web APIs, enabling invited third-party developers to integrate real-time CGM data into their digital health apps and devices.

“The new APIs will help seamlessly integrate the power of real-time Dexcom CGM data into some of the leading diabetes and digital health solutions,” explained Jake Leach, chief technology officer at Dexcom

“FDA clearance of our real-time APIs further solidifies Dexcom as the leader in interoperable CGM, giving Dexcom users even more choice in how they view and interact with their glucose data,” said Leach.

People with diabetes and their healthcare providers will benefit from the integration of real-time Dexcom CGM data into third-party apps and devices in a multitude of ways. For example, it will:

  • Allow users to quickly see all their therapy data in one place
  • Empower users to utilize the apps they find most beneficial for a more tailored Dexcom experience
  • Enable in-the-moment diabetes management coaching and feedback

Garmin, Teladoc Health

Several prominent diabetes and digital health companies have been invited to access the real-time APIs and are already in the testing and development phase, including Garmin and Teladoc Health’s Livongo for Diabetes.

Joe Schrick, vice president of fitness at Garmin, said: “Garmin welcomes the opportunity to bring Dexcom CGM data to runners, cyclists and everyday users who rely on the technology 24/7 to proactively manage their diabetes. We are proud to be part of this integration that will allow users a secondary way to quickly and discreetly view estimated glucose levels and trends right from their smartwatch at any time.”

  • For more information, visit: Dexcom.com/WebAPI.
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NDD updates EasyOne product range to be compliant with ATS/ERS spirometry standard

, 16 July 2021/in Product News /by panglobal

NDD Medical Technologies (NDD), a leading provider of diagnostic technology enabling healthcare professionals the early detection of COPD and other chronic lung diseases, has updated the entire EasyOne® product range, including the EasyOne Air, Easy on-PC, EasyOne Pro, and EasyOne Pro LAB, to be compliant with the ATS/ERS Standardization of Spirometry 2019.

Read more
https://interhospi.com/wp-content/uploads/sites/3/2021/07/NDD-spirometry-scaled.jpg 1433 2560 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2021-07-16 11:11:072021-07-16 11:11:25NDD updates EasyOne product range to be compliant with ATS/ERS spirometry standard

Nova POC creatinine/eGFR method more accurate than laboratory method: large medical centre study shows

, 16 July 2021/in Product News /by panglobal

In a 670-patient study funded by the International Society of Nephrology, the South Africa Medical Research Council, and the University of Witwatersrand, Johannesburg, South Africa, the Nova POC StatSensor Creatinine/ eGFR meter was more accurate than the central laboratory IDMS-traceable Jaffe methodology in estimating GFR when both methods were compared to measured GFR (mGFR).

Read more
https://interhospi.com/wp-content/uploads/sites/3/2021/07/StatSensor.jpg 1736 1519 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2021-07-16 11:02:012021-07-16 11:04:53Nova POC creatinine/eGFR method more accurate than laboratory method: large medical centre study shows

Cognoa’s autism spectrum disorder diagnosis aid approved by US FDA

, 16 July 2021/in Product News /by panglobal

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.

Read more
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Greiner Bio-One introduces MiniCollect PIXIE heel incision safety lancet for in-fants

, 16 July 2021/in Product News /by Greiner Bio-One GmbH

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.

Read more
https://interhospi.com/wp-content/uploads/sites/3/2021/07/MiniCollect_system_01-scaled.jpg 1707 2560 Greiner Bio-One GmbH https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png Greiner Bio-One GmbH2021-07-16 10:46:012021-07-16 10:46:21Greiner Bio-One introduces MiniCollect PIXIE heel incision safety lancet for in-fants

Franz Morat unveils innovative system for repositioning bedridden patients

, 16 July 2021/in Product News /by panglobal

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.

Read more
https://interhospi.com/wp-content/uploads/sites/3/2021/07/FMG_Patient_repositioning-scaled.jpg 1440 2560 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2021-07-16 09:27:082021-07-16 09:56:19Franz Morat unveils innovative system for repositioning bedridden patients

Siemens Healthineers receives CE Mark for ACUSON AcuNav Volume ICE Catheter

, 16 July 2021/in Product News /by Siemens Healthineers

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.

Read more
https://interhospi.com/wp-content/uploads/sites/3/2021/07/siemens-AcuNav.jpg 768 1024 Siemens Healthineers https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png Siemens Healthineers2021-07-16 09:10:462021-07-16 12:43:19Siemens Healthineers receives CE Mark for ACUSON AcuNav Volume ICE Catheter

Cognoa’s autism spectrum disorder diagnosis aid approved by US FDA

, 29 June 2021/in Product News /by panglobal

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/
https://interhospi.com/wp-content/uploads/sites/3/2021/06/kid.jpg 1134 1701 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2021-06-29 11:46:582021-06-29 11:46:58Cognoa’s autism spectrum disorder diagnosis aid approved by US FDA
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