FDA clears KardiaBand: World’s first personal on the go EKG on your wrist

AliveCor announced FDA clearance of the KardiaBand single-lead ECG device for the Apple Watch. AliveCor are the pioneers in field of personal EKG technology. It’s now easy to keep a watch on your heart simply by wearing this device around your wrist. Pairing with the expertise and artificial intelligence of Apple Watch, Kardiaband can detect sinus heart rhythm and atrial fibrillation(Afib) discreetly in just 30 seconds by simply a touch of the button.

KardiaBand is a self-contained, FDA-cleared, miniaturized ECG device.

The results are displayed on the apple watch. The Kardia app pairs with SmartRhythm, a new feature within the Kardia app, and receives continuous inputs about the heart rate, rhythm and physical activity from Apple Watch's activity sensors. Using a FDA-cleared analysis algorithm, it can sense if something is not normal and notifies the user to capture an EKG. The Kardia’s ECG analysis algorithm also identifies if the ECG is normal or not. The captured EKG can be mailed to a healthcare provider.

The diagnostic yield is at par to a 14-day ambulatory event monitor and Holter monitor.

Physicians can use KardiaBand for arrhythmia assessment, managing patients with AFib, diagnosing AFib early in high risk patients and patient management of cardiac risk factors.

"KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health," said Vic Gundotra, CEO, AliveCor. "These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage AFib, a leading cause of stroke, and other serious conditions."

AFib affects nearly 30 million people round the globe, with 1 in 4 people more than 40 years at risk of developing it. It is leading cause of stroke and 2 out of 3 strokes are preventable if detected and managed on time.  

Dr. Ronald P. Karlsberg, MD FACC, Board Certified Cardiologist and Clinical Professor of Medicine, Cedars Sinai Heart Institute and David Geffen School of Medicine UCLA said, "This is a paradigm shift for cardiac care as well as an important advance in healthcare."

"Today, EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke. With an EKG device on the wrist, AFib can be detected wherever the patient is, 24 hours a day. In randomized research trials, KardiaMobile, the first AliveCor EKG device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care," he added.

People all around the world would be benefitted by AliveCor, because it provides peace of mind by providing important diagnostic tool and communication between the patient and cardiologist.  

The device runs on an internal lithium battery with a lifetime of 1-2 years, the sensor in KardiaBand is always ready to use - with the recording screen open on your Apple Watch, simply touch your index finger to the KardiaBand sensor to start a recording. 

KardiaBand is available starting today for $199 and requires subscription to AliveCor's Premium service for $99 a year. The combined system includes SmartRhythm notifications on Apple Watch; unlimited EKG recordings; automatic detection of Atrial Fibrillation or normal sinus rhythm; the unlimited ability to send EKG readings to anyone via email; unlimited cloud history and reporting of all EKGs ever taken; weight and medication tracking; and a mailed monthly paper report on readings taken each calendar month.

If you do not have Apple Watch, you can still use Kardia to record EKG on your mobile. The basic service and Kardia app for mobile costs $99 as compared to KardiaBand which costs $199.

AliveCor
News Release

All Media: AliveCor

FDA clears Hologic’s Quantra 2.2 Breast Density Assessment Software during routine screening mammography

Hologic Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software. The software helps radiologists and clinicians to provide information about breast density to women during routine breast cancer screenings.

Quantra standardizes breast density reporting and helps eliminates the visual subjectivity by radiologists, through a proprietary algorithm powered by machine learning. The software classifies the breast tissue into four density categories based on  ACR Breast Imaging Reporting and Data System( ACRBI-RADS®) Atlas 5^th Edition, based on the distribution of fibroglandular tissue  and texture of breast tissue.

The BI-RADS® Atlas provides standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast.

The Quantra software is compatible with Hologic's 3D Mammography systems, including the new 3Dimensions mammography system, which is designed to be the fastest, highest resolution breast tomosynthesis system ever, with the 'Intelligent 2D imaging technology'.

Nearly 40% of women between the age of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and necessitates additional imaging, resulting in increased patient anxiety and unnecessary facility costs. Perhaps most importantly, women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts.

The software is one of several groundbreaking products that is available for demonstration in Hologic's booth (#4705) at the ongoing 103^rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) at McCormick Place in Chicago from Nov. 26 to 30.

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "As the global leader in breast cancer screening technology, we relentlessly pursue the development of clinically superior products that address the unmet and changing needs of our customers and their patients, especially when it comes to breast density. Quantra software is yet another example of our dedication and we are proud to feature it – along with a number of other new, breakthrough products – for the world's leading radiologists at RSNA this week."

Earlier this year, FDA approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening for women with dense breasts. 

Hologic also commercially launched its Smart Curve breast stabilization system at the same time, that makes mammography experience less painful for women without compromising on image quality and diagnostic accuracy.

Hologic Worldwide Quantra Volumetric Breast Density Assessment

First artificial intelligence robot passes China’s medical licensing examination

A Robot named Xiaoyi have cleared China’s medical licensing examination in August of this year, reported south China morning post.  The robot is aptly named Xiaoyi which means ‘little doctor’ and completed the test in fraction of time as compared to his human competitors.

In practice run, Xiaoyi could only score 100/600 and the passing score is minimum of 360. 

Disappointed by the practice test score, Xiaoyi decided to study hard and was trained to absorb the contents of dozens of medical textbooks, 2 million medical records, and 400,000 articles to develop the kind of reasoning needed to be a doctor, The Beijing News reported on the weekend.

It passed the test with a score of 456.

The first robot to ever pass a medical licensing examination is developed by iFlyTek, in coordination with Tsinghua University.

The robot was able to identify words, link between words and sentences to develop a capacity to reason, but did not do well in question pertaining to patients’ cases.

So, the healthcare industry can be rest assured that Xiaoyi will actually not replace physicians and health care providers in current setting. But, it can certainly be useful in assisting physicians to interpret the signs and symptoms faster and making suggestions.

The robot will officially be launched in March 2018 and the company vision is, it can help patients in remote Chinese villages, which are always short of primary care physicians.

China has already opened the world’s first artificial intelligence based treatment center.

Video: Applications of 3-D printing for Cardiology

https://futurism.media

3-D printing technology allows you to print in three dimensions, instead of usual two. It is emerging technology that has many lives saving applications in medical field and its full potential is yet to be utilized by the physicians and researchers. It is called bioprinting when it is used in medical arena to print body parts.

You can print body parts made up of gamut of materials from powdered titanium alloy, plaster, ceramic and glass to thermoplastic and even photopolymers. The body parts can be grasped in hands.

It has some special applications in cardiology, and can be divided into 3 categories. It allows for printing models of babies with congenital heart diseases, so that the surgeon is trained before the actual procedure and knows instantly what operation is to be performed. Customized heart parts that are very near to the natural body parts can be printed so that replacement surgeries are easy and functional. It has a huge potential in the field of adult structural heart defects. The third category is a distant ‘moonshot’-the 3D fabrication of an entire, implantable replacement heart.

The actual technology is nearly 30 years old, but has made its way in the medical field since last 10 years.

Imaging of the heart model primarily by computed tomography (CT) and magnetic resonance imaging is the first step in printing the heart. A 3-D modelling program then makes a digital file in a computer-aided design (CAD) file. The digital file is then uploaded to a 3-D printer along with the appropriate raw material and the object is created layer by layer.

In this video Dee Dee Wang, M.D., Director, Structural Heart Imaging at Henry Ford Hospital, Detroit, explains how her center uses 3-D printing and computer aided design (CAD) software to improve patient outcomes.

FDA clears world’s first and only, non-radioactive, wire free breast tumor localizer for extended use

Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term use. The SAVI SCOUT reflector is an integral part of the SAVI SCOUT® surgical guidance system, a novel wire free technology that uses real-time audible and visual indicators for precise localization of tumor during lumpectomy and excisional biopsy procedures.

This technology is the first and only non-radioactive implant, that uses electromagnetic wave technology, with no restrictions on the length of time the reflector can remain in the breast. 

This will enable the surgeons to precisely target the affected tissue using the system’s capability of 360˚ detection and ability to pinpoint tumor location down to ±1mm, this conserves breast tissue and is more aesthetic for women at the same time increasing the surgical precision and reducing the need for repeat surgery.  

In addition, a woman with in situ SCOUT reflector can easily undergo MRI, as it does not interfere with the study.

The SCOUT reflector is 4 mm in size, and remains completely passive till it is activated by a handheld radar system. As the radar system is placed against breast, the Scout system starts sending audio-visual cues for the precise position of the reflector.  

It also eliminates the need of same day surgery and can remain in place between the time of biopsy to surgery.

Before the clearance the reflector was only allowed to stay in place for 30 days, now the time limit has been removed.

The device received its initial clearance in 2014, based on a result of small pilot study of 50 patients published later in June 2016 in the Annals of Surgical Oncology.

A larger subsequent study also by Cox et al. was published in Annals of Surgical Oncology involved 154 patients and the researchers concluded that, “SCOUT provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.”

Dr. Alice Police was the first surgeon in the country to adopt SCOUT in late 2015, at UC Irvine Medical Center, in Orange County, CA.   “My focus is always on finding a better breast cancer operation,” Dr. Police said.   “SCOUT is the standard of care for my breast localizations as I utilize this wire-free approach for all scenarios requiring localization.  The distance feature provides more control over the procedure which is important for predictable outcomes.”

Cianna Medical requires that each site and physician using SCOUT Radar Localization successfully complete training prior to initial cases. 

SCOUT Real-Time Distance Animation from Cianna Medical Inc. on Vimeo.

microMend: A novel way to mend the wound after surgery

Soon sutures and staples are the current options for closing the skin, but a unique wound closure device is in the market called microMend, developed by a Seattle-based medical device company-KitoTech Medical.

The product is a unique combination of butterfly shaped bandage and staples. The device is made up of material similar to bandage, but has two arrays of tiny “microstaples” on either side of the ‘wing’. 

The device is flexible and combines the strength of staples with easy application of a bandage, closing the wound three times faster.

The even distribution of staples results in less scarring and inflammation, and provides an effective barrier against skin infection. No additional dressing is required to close the wound It’s tensile strength lasts as long as it takes for the wound to heal.

The removal is painless, and it could be removed at home by patient himself when instructed by a healthcare personnel.

microMend finds initial applications in cosmetic and plastic surgeries, but it is also useful in emergency settings, minimal invasive surgery, laparoscopic surgeries, vascular and spinal surgeries.

KitoTech Medical, recently introduced microMend at the recent Annual Meeting of the American Society for Dermatologic Surgery (Oct 5 - 7). The company has conducted initial studies with dermatologists and plastic surgeons, but more studies with other surgical specialties are on the way.

The product is a brain child of Dr. Ron Berenson, a biotech and medical device entrepreneur, who got inspiration for this idea by the work of Dr. Marco Rolandi, a professor at the University of Washington. He was working on the use of tiny chitosan microneedles to heal wounds.

Dr. Ron Berenson is hopeful that the product use will extend to many more specialties will become a major player in the industry of wound closure products.

He says, “Its simplicity is deceptive. In fact, the design and development process took years.”

For additional information, clinical studies data, photos and videos visit: http://www.kitotechmedical.com/

                     HOW TO APPLY MICROMEND