Dr Kalyanam Shivkumar Named New Editor of JACC: Clinical Electrophysiology

February 25, 2020

A specialist in interventional cardiac electrophysiology, Dr Kalyanam Shivkumar has developed several innovative techniques for the catheter ablation of cardiac arrhythmias and other cardiac interventions. His research work, both basic/translational and clinical, relates to mechanisms of cardiac arrhythmias in humans and the role of the autonomic nervous system in sudden cardiac death.

Shivkumar has been elected as a Fellow of the American College of Cardiology (FACC) and to the membership of the American Society of Clinical Investigation.

“It is a rare honor and a privilege to serve as the editor-in-chief of JACC: Clinical Electrophysiology,” Shivkumar said. “Our editorial team looks forward to seeking and publishing the very best science in the field of cardiac arrhythmias.”

Launched in 2015, JACC: Clinical Electrophysiology is a monthly subspecialty journal encompassing all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. The journal occupies a unique position by focusing primarily on the practicing clinical electrophysiologist’s need for context and critical information to direct therapeutic decision making. It aims to publish only the highest caliber papers and authors, focusing on content that advances the field.

Shivkumar’s first issue of JACC: Clinical Electrophysiology will publish in July 2020.

Other non-profit news.

ClinOne Offers Complimentary Support to Researchers Racing to Develop the Coronavirus or COVID-19 Vaccine

February 25, 2020

The focal point of the initial outbreak was the Huanan Seafood Wholesale Market and the ingestion of common meals such as bat and snake; however, the zoonotic origin was quickly dispelled when more cases were identified outside of the market area and into other Chinese provinces, confirmation of person-to-person transmission, and utilization of medical imaging. To date, there are 79,360 confirmed cases worldwide, 2,619 associated deaths, and 24,963 cases that have recovered (Coronavirus COVID-19 Global Cases by Johns Hopkins CSSE, 23 February 2020).

The first confirmed death from COVID-19 occurred on 09 January 2020 and marked the beginning of the race to create a vaccine that will treat and prevent the ill effects of this coronavirus. Several pharmaceutical companies, the U.S. National Institute of Allergy and Infectious Diseases, Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI), and a host of others have begun researching the cure; some are preparing for animal testing, and others are developing novel approaches to vaccine development. “Any vaccine will likely require human testing before final approval is awarded, and disease prevention can be achieved,” said Dr. Elizabeth Esterl, RN, VP of Operations and Research. “I am honored and humbled to offer the services of ClinOne to researchers worldwide. We are willing to assist in any way possible to stop the spread of this virus and associated deaths,” said Esterl, who has spent her career managing research institutions, including Colorado Children’s Hospital and National Jewish Health.

ClinOne offers the ability for researchers to connect directly to the patients, consent remotely, monitor symptoms of adverse reactions with wearable devices, and connect the sponsor, research sites and patients to ensure compliance and enhance the user experience. ClinOne is offering its support to accelerate the process of COVID-19 vaccine development to pharmaceutical companies by providing its clinical trial management technologies complimentary. “We are at an unprecedented time with managing the COVID-19 coronavirus outbreak around the world, and pharmaceutical partners are urgently needed to research and develop viable treatment options. We are here to support their efforts by providing the ClinOne suite of technologies free of charge,” said Rob Bohacs, CEO.

United Imaging’s Emergency Radiology Departments Support Mobile Cabin Hospitals, Facilitate 5G Remote Diagnosis

February 25, 2020

Mobile Cabin Hospitals: To meet these needs, United Imaging created a flexible and intelligent solution customized for MCHs called Emergency Radiology Departments (Emergency RD). The Emergency RD at the MCH located in Wuhan International Conference & Exhibition Center was the first put into service, with nearly 200 scans performed on the first day. United Imaging has also completed installations at Hongshan Stadium, Hanyang International Exhibition Center, and Tazi Lake Sports Center, and the company is actively working toward installing another six units in other locations.

United Imaging and its shareholders announced a donation of devices and services worth $7 million to MCHs in Wuhan, with plans to donate a further $7 million worth of devices and services to Henan Province.

According to Qu Feng, United Imaging’s head of Customer Relationship Management for Hubei, the Emergency RD provides a perfect solution to the current challenges, with all the necessary equipment contained within an independent 20 square meter scanning room and operating compartment. The modular design enables fast assembly/disassembly and transportation, with plug-and-play compatibility. Furthermore, the Emergency RD is waterproof, with built-in insulation and thermostatic features that make it possible to deploy the solution in extreme environments during emergency or disaster relief efforts.

With scanning workflow fully empowered by the AI-based uVision technology, the Emergency RD enables automatic patient positioning and scanning from the operation room. Technologists operate the scanner from outside of the scan room, reducing the risk of cross-infection between healthcare professionals and patients. In addition, streamlined workflow allows for high-load and efficient scans each day.

In the absence of on-site radiologists at the temporary MCH sites, remote diagnosis is essential. The Emergency RD at Wuhan International Conference & Exhibition Center is connected to Wuhan Union Hospital (WUH) through a 5G network, four times faster than traditional networks. Once patients are scanned at the MCH, their CT images are transferred to WUH, where the images are read remotely by radiologists.

In order to offload the diagnosis and treatment work of frontline healthcare professionals, UIHCloud, United Imaging’s cloud services, has been deployed at many hospitals in Wuhan. It connects community service centers to upper level hospitals that provide diagnostic services utilizing the advanced AI applications deployed on UIHCloud. At Zhongnan Hospital of Wuhan University and Wuhan No. 7 Hospital alone, more than 4,300 cases were diagnosed remotely through UIHCloud by now.

Zynex Receives FDA Clearance for its Blood Volume Monitor

February 25, 2020

Zynex, Inc. today announced the U.S. Food and Drug Administration (“FDA”) granted 510(k) clearance for sale in the U.S. for the CM-1500 Blood Volume Monitor.

Thomas Sandgaard, CEO said: “I am very excited to finally have obtained FDA clearance to sell our non-invasive Blood Volume Monitor in the U.S. The device is fully developed, has performed well in multiple clinical trials and can guide medical professionals in hospitals and surgical centers towards better fluid management during surgery and in recovery settings. Fluid management during and after surgery is one of the largest unmet needs in hospitals today.”

Novalung ® for Treatment of Acute Respiratory and Cardiopulmonary Failure Receives FDA Clearance

February 24, 2020

Novalung ® is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before,” said Mark Costanzo, President of Renal Therapies Group, the technologies and pharmaceuticals division of FMCNA. “We’ve applied our leadership and technical expertise in renal medical devices to elevate standards for acute respiratory and cardiopulmonary failure treatments and technologies. We’re proud to broaden our care offerings to provide new therapies for patients with acute cardiopulmonary conditions.”

Patients in acute respiratory or cardiopulmonary failure often struggle to get oxygen into their bloodstream or expel carbon dioxide out of their bodies, resulting in dangerously low levels of oxygen. This acute low oxygen state can result from a wide range of conditions. Recent research has shown a significant increase in the use of ECMO with evidence of improved survival rates and no increase in hospitalization costs.¹

The Novalung ECMO system pumps and oxygenates a patient’s blood, reducing the stress on damaged heart and lungs. Additionally, Novalung offers an alternative to the need for invasive mechanical ventilation, which can cause additional lung injury as a result of the air pressure required. Novalung offers a portable therapy solution designed to improve clinical outcomes and accommodate various clinical care settings such as intensive care units, operating rooms, cardiac catheterization labs, and emergency departments.

“A long-term, effective ECMO solution gives critically-ill patients the time and support needed to heal,” said Dr. Robert Bartlett, Professor Emeritus, Section of General Surgery, Division of Acute Care Surgery, University of Michigan School of Medicine. “The system’s pressure sensor technology ensures continuous monitoring and accurate flow control of each patient’s blood, allowing the care team the flexibility needed to treat the underlying health issues.”

The use of Novalung as an ECMO device for critical care has several benefits, including minimizing the need for invasive ventilation, the ability to provide support after multi-organ injuries, and better survival outcomes for patients in cardiac arrest. This integrated heart and lung therapy platform provide the lifesaving support needed for patients in critical conditions.

FMCNA expects Novalung to be available within the U.S. mid-year 2020. More on this here.

INDICATIONS FOR USE

The Novalung System is indicated for long-term (>6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
ECMO-assisted cardiopulmonary resuscitation in adults

Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.

Abond CRO Announces Hiring Charley Bratton as Senior VP Corporate Marketing and Sales

February 24, 2020

According to Dr. Phil Doren, CEO, “Mr. Charley Bratton will lead an array of activities contributing to the company’s plans for accelerated growth and expansion of service offerings.”

“Abond CRO is excited to have Charley Bratton join our company. He brings years of sales and marketing experience, industry-wide knowledge and an incredible amount of energy to this role. He is well-respected in the industry for providing client service excellence to meet drug and device development needs.

Charley Bratton will add to the leadership team that we have in place to serve our pharmaceutical, biotech and medical device customers. His leadership experience and industry expertise in business development and marketing greatly enhances our organizational capability to provide excellent support in those areas to our customers,” Doren added.

EarlySense Names John Dragovits as New SVP of Strategic Partnerships

February 24, 2020

Matt Johnson, EarlySense CEO notes, “Partner collaboration has played an important role in EarlySense’s growth and has been instrumental in helping us reach our goal of establishing contact-free continuous monitoring as a standard of care.” Johnson added, “We look forward to tapping into John’s expertise to strengthen current strategic partnerships and help bring in new relationships that will enable us to continue to elevate patient safety and care.”

John Dragovits has more than 30 years of experience as a healthcare and healthcare IT executive leader. He previously served in VP roles with electronic health records companies Cerner Corporation (Nasdaq: CERN) as well as Senior Vice President and General Manager of Revenue Cycle at Allscripts (Nasdaq: MDX). He was also held health system senior executive roles, having served as Chief Financial Officer and Chief Operating Officer of Dallas’ Children’s Health and Executive VP and CFO of Parkland Health & Hospital System. Mr. Dragovits is a former U.S. Navy Officer as well as a CPA and holds graduate and undergraduate degrees from Rice University.

“EarlySense is a recognized innovator within the patient monitoring markets, and has played an important role in advancing patient safety and outcomes in healthcare facilities worldwide,” said Dragovits. “I am honored to join the EarlySense team and to explore new avenues to bring contact-free continuous monitoring to even more patients, families and health teams.”

Luminex Corporation Submits VERIGENE® II Respiratory Flex Assay for FDA Clearance

February 24, 2020

Luminex reports this assay, along with the Gastrointestinal (GI) Flex Assay, both run on Luminex’s new VERIGENE II system. The GI Flex Assay is an automated test for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples. Both are now under review with the FDA, and Luminex anticipates launching the new VERIGENE II assays mid-year.

“We are delivering on our strategy and our promise to expand the menu of clinically relevant, high-value tests that accelerate and simplify diagnostic testing,” said Homi Shamir, President, and CEO of Luminex. “We’re also demonstrating once again the cost-effectiveness of rapid testing on a Luminex platform. The flexibility of the automated VERIGENE II System uniquely allows clinical laboratories to select, test and pay for only the targets ordered for each patient. This is a game-changer for many laboratories.”

The VERIGENE II System is a benchtop molecular diagnostic system that uses advanced automation and specialized chemistry to enable rapid, sample-to-result detection. The RSP Flex Test is performed on this system utilizing reverse transcription, polymerase chain reaction, and array hybridization to detect specific respiratory viral and bacterial pathogen nucleic-acid gene sequences.

“By expanding the foundational assays on our next-generation VERIGENE system to a wider variety of common viruses and bacteria, we are helping laboratories deliver fast, accurate results and are streamlining the process of sample testing,” said Shamir.

When targeted therapies depend on clinical test results, testing of nasopharyngeal samples for specific pathogens is highly useful, especially given that respiratory tract infections (RTIs) are among the three most common acute illnesses evaluated in outpatient care.¹ Children are particularly vulnerable to RTIs, with an average of six per year.² If these illnesses are not diagnosed accurately or quickly enough, they can lead to more serious illness and, in severe cases, to increased childhood mortality. The VERIGENE II RSP Flex Assay delivers a critical test that is designed to address this widespread and costly challenge.

Dr Edward Evantash Appointed CMO of Alydia Health

February 24, 2020

“I’m thrilled to welcome Dr Edward Evantash to our outstanding and growing team at Alydia Health,” said Anne Morrissey, Chief Executive Officer. “His extensive executive leadership experience and the impressive clinical background will prove invaluable to Alydia in our mission to make childbirth safer for all mothers. As we prepare for commercialization of the Jada System for postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding, Edward’s leadership in the obstetrical community and societies will be vital to achieving our mission.”

Dr Edward Evantash has dedicated his career to improving all aspects of medical care for women. In his most recent role as Medical Director and Vice President, Global Medical Affairs at Hologic, Dr. Evantash helped expand the company’s portfolio to include products that improve women’s health and well-being. Dr. Evantash previously served as Division Chief of Obstetrics and Gynecology at Tufts Medical Center while directing the medical student clerkship as an Assistant Professor. He received his medical degree from the University of Pennsylvania School of Medicine as a Penn Scholar.

“The team at Alydia is addressing a major problem in women’s health by focusing on postpartum hemorrhage or abnormal uterine bleeding, where there is an immense need for additional treatment options,” said Dr. Evantash. “Having practiced as an OB-GYN for nearly 20 years, I’ve seen firsthand the burden that childbirth complications requiring invasive treatments can have on new mothers, their families, and their health care providers. I share Alydia’s passion for bringing much-needed innovation to maternal health and look forward to helping the organization advance new technologies for postpartum hemorrhage and abnormal uterine bleeding in the U.S. and globally.”

The Jada System™ is an innovative technology designed to rapidly control and treat PPH or abnormal postpartum uterine bleeding by encouraging the uterus to contract quickly, naturally compressing the open blood vessels. Alydia recently completed enrollment in the PEARLE IDE Study to support the company’s planned 510(k) submission to the U.S. Food and Drug Administration (FDA) for marketing clearance of the Jada System.

Facts provided by the company:

Immediately following childbirth, the uterus should contract to stop the normal bleeding associated with delivery. A mother with risk factors such as a long or challenging delivery might find that her uterus is unable to contract on its own, causing uncontrolled bleeding known as postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding. PPH is one of the most common complications of birth that can result in emergency interventions such as hysterectomy, expensive blood transfusions, and, in some cases, maternal death. According to the Centers for Disease Control and Prevention (CDC), severe maternal morbidity has been steadily increasing in the U.S. in recent years, nearly tripling between 1993 and 2014.¹ Despite the unacceptably high rate of complications from childbirth requiring treatment, there remains a significant need for effective therapies.

References

1 https://www.cdc.gov/vitalsigns/maternal-deaths/index.html

WaveGuide Corporation Launches World’s First Portable NMR Device

February 24, 2020

WaveGuide Corporation today launched its new WaveGuide Formµla™, the world’s only battery-powered, compact scientific instrument that performs rapid screening and diagnostics of solid and liquid substances spanning an array of markets and applications.

The WaveGuide Formla™ micro NMR delivers performance as good or better than larger, more costly benchtop NMRs, in a portable, easy-to-use device making it ideal for applications requiring in-situ decision making, including pharmaceutical, petrochemical, food quality, food safety, and consumer product authentication applications. The WaveGuide Formla™ provides quantitative analysis for a wide range of real-world scenarios—from detecting impurities in lubricants indicative of engine and component wear to authenticating biological therapies and vaccines to rapidly screening patients for specific disease states.

The WaveGuide Formla™ represents a significant departure from large, expensive, benchtop NMR solutions. In addition to trained operators, benchtop NMR systems can require up to 24 hours for the device and sample to temperature stabilize. The WaveGuide Formla™ requires minimal user training and little to no sample preparation. After a quick internal calibration, the instrument is ready to use within seconds.

The WaveGuide Formla™ will be launched at Pittcon 2020 booth #4911 in Chicago Illinois, March 2-5, 2020. A technical presentation, “Portable Forensic Analysis of Biological Agents and Consumer Products,” will be delivered by WaveGuide’s Head of Biology, Massimiliano La Colla Ph.D., at the conference on March 4.

“Until now, the size, cost and complexity of commercially available NMR platforms has limited their use to low volume and niche applications with high fixed costs. From WaveGuide’s founding in 2015, we have worked diligently to change this paradigm, partnering with Harvard University’s Department of Physics to pioneer a new class of micro NMR analyzer technology,” said Nelson K. Stacks, CEO and President of WaveGuide Corporation. “The WaveGuide Formla™ is truly a revolutionary development, opening the door to a range of in-situ applications in healthcare, consumer products, and industrial products that were previously impractical or impossible with the existing NMR technology.”

The WaveGuide Formla™ micro NMR is based on patented technology that enables small, low-cost, inhomogeneous magnets to produce a handheld chemical analyzer based on NMR, amplifying the NMR signal-to-noise by a factor of 10,000. WaveGuide has applied for six additional patents, bolstering the core technology.

More on the features and benefits can be found here.

WaveGuide Corporation today launched its new WaveGuide Formµla™, the world’s only battery-powered, compact scientific instrument that performs rapid screening and diagnostics of solid and liquid substances spanning an array of markets and applications.

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