ShiraTronics, Inc. a privately held medical device company, announced today that it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the FDA for its innovative neurostimulation therapy targeting the millions of chronic migraine sufferers.

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

“We are thrilled to have received this important designation from the FDA. This reinforces the severity of the disability these patients suffer and the importance of new therapy options,” said Lynn Elliott, Chief Executive Officer of ShiraTronics, Inc.

“We applaud FDA’s Breakthrough Device designation on behalf of the millions of patients suffering from chronic migraine who are actively seeking treatment options to deal with this life limiting and severely disabling condition,” said Mudit K. Jain, PhD, a co-founder and Chairman of the Board of ShiraTronics, Inc.

Puzzle Medical Devices Inc., announced that the U.S. FDA has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure.

The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain medical devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions, including a prioritized review of market approval regulatory submissions.

“The FDA’s recognition of Puzzle Medical’s heart pump as a Breakthrough Device is a testimony to the innovative and disruptive nature of this device,” said Philippe Généreux, MD, interventional cardiologist at Gagnon Cardiovascular Institute, Morristown Medical Center, New Jersey, USA, and Chief Medical Officer of Puzzle Medical. “This novel technology has the potential to help millions of patients suffering from heart failure who currently have no treatment option other than medical therapy.”

Puzzle Medical’s focus is to improve patient quality of life and reduce the global economic burden related to heart failure. Puzzle Medical is developing a proprietary transcatheter heart pump associated with minimal trauma to the blood components, allowing for safe and efficient heart support without open-heart surgery.

“I have been impressed by the progress made by the Puzzle Medical team so far. Their device clearly answers an unmet need among patients suffering from heart failure,” said Professor Alain Cribier, MD, of Rouen, France.

“Puzzle Medical is excited about this important milestone and is thankful to the FDA for the Breakthrough Device Designation,” said Jade Doucet-Martineau, co-founder and CEO of Puzzle Medical. “Leveraging decades of expertise in the development of transcatheter therapies, the Puzzle Medical team will fiercely continue the development of the most efficient and safest heart pump ever created.”

About Puzzle Medical Devices Inc.

Puzzle Medical Devices Inc. is a Canadian company specializing in the development of a minimally invasive transcatheter heart pump. Puzzle Medical enables mechanical hemodynamic support to be more efficacious, safer, and more economical, resulting in increased accessibility, improved patient quality of life and reduction of the global economic burden related to the disease. To date, Puzzle Medical has successfully completed acute in-vivo preclinical implantations with tremendous success.

NextGen Healthcare, Inc., a leading provider of ambulatory-focused technology solutions, announced that Loden Vision Centers, a Nashville-based provider specializing in cataract and LASIK surgery, is leveraging NextGen® Revenue Cycle Management (RCM) Services for more efficient medical billing across its five locations. After implementing the services during the COVID-19 health crisis, Loden Vision Centers experienced a 32 percent increase in payments above its 12-month average and has reduced days sales outstanding (DSO) by 16 percent.

In partnership with NextGen® RCM Services, the practice has improved charge capture accuracy and billing while enhancing its reimbursement processes for retinal condition injections. The centers also use the platform’s financial analytics to assess the effectiveness of its LASIK surgery marketing efforts in specific geographic locations.

“The COVID-19 pandemic immediately impacted our practice volume and working with a trusted advisor like NextGen Healthcare has enabled us to weather the storm,” said Matthew Pierre, chief executive officer for Loden Vision Centers. “The NextGen RCM Services team keeps up with our needs and allows our staff to focus on patient care versus dealing with billing and collections during this exceptionally turbulent time in eye care. We now have much better insight into our metrics and can quickly analyze performance to make data-based decisions that improve our clinics and more effectively serve our community.”

“For specialty practices such as ophthalmology, the pandemic has highlighted the need to stabilize revenue and optimize operations,” said John Beck, chief solutions officer for NextGen Healthcare. “By integrating NextGen® RCM Services, eye care providers can sustain and increase revenue while enhancing patient engagement with a seamless billing experience.”

About NextGen® RCM Services

NextGen® RCM Services helps practices prevent denials, improve velocity of collections, increase net collections, reduce days in accounts receivable and enhance the patient experience. NextGen Healthcare’s RCM team serves approximately 6,000 providers across the U.S., manages more than 12 million claims annually and collects more than $2 billion per year.

As a specialist digital health fund, Sydney based Healthcare Ventures will invest in early stage and growth companies transforming healthcare via digital health technologies.

The investment strategy focuses primarily on Australian companies going global, led by visionary founders, that are redefining how healthcare is provided and consumed whilst delivering better outcomes for all.

The Healthcare Ventures team brings investment, medical and digital health expertise to the table. All are entrepreneurs in their own rights:

Partnership and Fund Manager Board

Roger Allen AM – Chairman and pioneer of Australia’s venture capital industry is a renowned active early-stage investor and director. Roger has had heavy involvement in several very successful ASX listed digital health companies, including Volpara Health and the recently listed, Doctor Care Anywhere.
Dr Louise Schaper – Australia’s pre-eminent digital health evangelist and CEO of the Australasian Institute of Digital Health.
Darren Heathcote – Experienced adviser and investor in healthcare.
Dr Bronwyn King AO – Radiation Oncologist and founder and CEO of Tobacco Free Portfolios.

They are joined by an esteemed Advisory Board:

Grahame Grieve – the ‘Father of FHIR’, advisor to governments, vendors and care providers globally, head of the global FHIR community and is on the list of 15 Health IT Standards and Interoperability Rockstars to Know.
Dr Amandeep Hansra – General Practitioner, angel investor, advisor and strategist, Ex CEO Telstra Readycare and founder of Creative Careers in Medicine, a community of over 10,000 doctors and co-founder of Australian Medical Angels with over 300 active health tech angel investors.
Adj A/Prof David Rowlands – One of Australia’s most senior health informaticians with extensive international experience.
Dr Arran Schlosberg – Medical doctor, software engineer, and co-founding CTO with deep technical expertise and international experience in the healthcare industry, including at HealthMatch, Google, and DeepMind.

“The digitally enabled transformation of healthcare across the globe is happening at a phenomenal pace, accelerated by COVID19 and the resulting focus on data and technologies for advanced individual and population health. We see this as providing significant opportunity for a specialist fund and specialist team focussed on digital health investment,” said Dr Schaper.

“In 2020, digital health start-ups in the USA attracted a record US$14 billion of investment capital, in the largest funding year on record. Australia is rich with brilliant innovators and yet funding is only starting to see traction. Healthcare Ventures aims to rectify that.”

Launching the fund, Allen said “I have been working with and invested in a number of talented health professionals and am seeing continuous deal-flow of innovations coming from the medical community. This shouldn’t come as a great surprise given our best and brightest have been going into medicine but what has changed is a strong entrepreneurship mindset and the ability to transform practises through digitisation. I believe the best way to handle this dealflow is to have a dedicated team and specialist fund led by health professionals supported by strong investment and technical capabilities. The fund will be a relatively small fund and will seek to partner and co invest with many more generalised VC funds both in Australia and overseas.

Focussing on technology, Healthcare Ventures will pay close attention to innovations in fields such as artificial intelligence, augmented reality/virtual reality, large scale data, advanced diagnostics, health IOT and telehealth,” said Allen.

“We acknowledge that investing in healthcare is challenging, as you need to have intimate knowledge of workplace practises and that means being able to both understand and navigate the many nuanced challenges these health professionals face every day,” said Darren Heathcote. “We took great care, over a considerable amount of time, to build a partnership and advisory board that would provide us with the necessary expertise, such that today, we have a dedicated, specialist team of medical and digital health led professionals and investment experts, able to assist our portfolio companies to execute on the opportunities,” said Heathcote.

“Healthcare Ventures aim to commercialise innovation from the health sector, advance the growth of local industry and the export of Australian innovation and entrepreneurship to the world. Worldwide, we see in increasing demand for digital transformation in healthcare. Australia’s technical expertise has long established itself as an influential and effective provider of innovative solutions for many sectors and we believe Australia’s reputation for high standards and rigorous regulatory oversight sets us apart,” said Dr Schaper.

VitalHub Corp. is pleased to announce a material licensing transaction comprising the installation of recently-acquired subsidiary Intouch With Health’s digital health platform at Surrey and Sussex Healthcare NHS Trust.

The contract will focus on East Surrey Hospital and will include the Company’s proprietary Flow Manager, Check-in, Patient Calling, and Wait Times solutions, as well as an integration with Cerner’s Patient Administration System. The Trust provides emergency and non-emergency services to the residents of east Surrey, north-east West Sussex, and South Croydon, including a range of outpatient, diagnostic and less complex planned. In total, the Trust serves a population in excess of 535,000 people.

This deal comes as a result of the Trust having identified a need for platform which would enable them to undergo a digital transformation of their outpatient services, effectively resulting in the replacement of the Trust’s previous self-check-in product in favour of Intouch’s solutions.

Given the current strains on health systems globally, there is an incredible need to digitally transform outpatient experience. The demands on hospital services are growing, requiring the Trust to improve the management of how outpatient journeys are managed for both patients and staff in order to increase operational efficiency, enhancing patient care and enriching patient experience. The Intouch solutions that the Trust will implement are aimed at helping to deliver an improved hospital experience for patients while alleviating pressure on the administrators and clinical staff.

“This transaction is one of a series of several licensing contracts with the NHS over the past year. The continued stream of requests for our services are a sign of the ongoing and increasing momentum that we’ve picked up,” said VitalHub CEO Dan Matlow. “We’re glad to be helping these institutions take part in the trend towards the digitization of outpatient services. Moving forward, we will continue to provide industry-leading patient flow and operational visibility solutions to healthcare organizations, maximizing health system efficiency, benefiting health systems, health professionals, and the patients.”

ABOUT SURREY AND SUSSEX HEALTHCARE NHS TRUST

Surrey and Sussex Healthcare NHS Trust provides emergency and non-emergency services to the residents of east Surrey, north-east West Sussex, and South Croydon, including the major towns of Crawley, Horsham, Reigate and Redhill. At East Surrey Hospital, Redhill the Trust has 697 beds and provide acute and complex services. In addition, they provide a range of outpatient, diagnostic and less complex planned services at The Earlswood Centre, Caterham Dene Hospital and Oxted Health Centre, in Surrey, and at Crawley Hospital and Horsham in West Sussex.

ABOUT VITALHUB

Software for Health and Human Services providers designed to simplify the user experience & optimize outcomes.

VitalHub provides technology to Health and Human Services providers including; Hospitals, Regional Health Authorities, Mental Health, Long Term Care, Home Health, Community and Social Services. VitalHub solutions span the categories of Electronic Health Record (EHR), Case Management, Care Coordination, Patient Flow & Operational Visibility, and DOCit Mobile Apps.

The Company has a robust two-pronged growth strategy, targeting organic growth opportunities within its product suite, and pursuing an aggressive M&A plan. Currently, VitalHub serves 275+ clients across Canada, USA, UK, Australia, Qatar, and Latvia. VitalHub is based in Toronto, Canada, with an offshore development hub in Sri Lanka. The Company is publicly traded on the TSX Venture Exchange under the symbol “VHI”.

Spok Holdings, Inc., a global leader in healthcare communications, announced the international expansion of its cloud-native communication platform, Spok Go®, with availability in Australia. Purpose-built in the cloud for healthcare, the Spok Go platform drives informed care by connecting clinical teams with the people and information they need when and where it matters most.

Spok has supported hospitals and health systems in Australia with advanced communication technology for decades. These organisations look to Spok to deliver meaningful improvements in the way care teams interact, intending to enhance outcomes. To achieve this, Spok Go drives clinical workflow automation that enables efficient and safe patient care. The platform automates key clinical processes, including the context needed for clinicians to make informed care decisions. Spok Go enables secure text messaging as an option for encrypted pager replacement, routes and escalates clinical alerts, and centralises directory and on-call scheduling information. It also encompasses operator console, emergency notification, and messaging solutions to support full care team communication.

“Spok Go is redefining the standard of smart, efficient healthcare communications by reducing the complexity that has long plagued everyday clinical interactions,” said Vincent D. Kelly, president and chief executive officer of Spok Holdings, Inc. “We are pleased to expand the game-changing Spok Go platform into the Australian market with the ability to meet the specific compliance and workflow needs of these hospitals and healthcare systems.”

Spok has enhanced Spok Go with the following capabilities to address requirements unique to Australia:

Compliance with local data residency and security regulations to protect patient information; this includes compliance with the Australian Privacy Principles (APPs). In Australia, no hospital, operational, or patient data of any kind is transferred out of the country. All data, as well as the Spok Go platform and Amazon Web Services (AWS), operate strictly within the borders of Australia.

Strong business continuity with AWS distributed across different locations to protect against loss of connectivity, power, and service-specific failure.

Excellent user experience and message delivery speeds for all customers in a deployed region.

Localised language support for Australian English, as well as appropriate date, time, and phone number formats.

About Spok

Spok, Inc., a wholly owned subsidiary of Spok Holdings, Inc., headquartered in Springfield, Virginia, is proud to be a global leader in healthcare communications. We deliver clinical information to care teams when and where it matters most to improve patient outcomes. Top hospitals rely on the Spok Go® and Spok Care Connect® platforms to enhance workflows for clinicians and support administrative compliance. Our customers send over 100 million messages each month through their Spok® solutions. When seconds count and patients’ lives are at stake, Spok enables smarter, faster clinical communication.

Mindray, a global leader in the development of innovative healthcare technology, has unveiled its new BeneFusion e Series, a revolutionary efficient infusion system for the healthcare industry. Available in three models, eSP, eVP and eDS, the BeneFusion e Series delivers efficiency in workflow, safety, application and informatics. This brand new series will be available in selected countries and regions.

Infusion pumps are in widespread use in clinical settings such as hospitals. However, errors or failures caused by these systems can have significant ramifications for patient safety. Emergency Care Research Institute (ECRI) found that medication errors caused by infusion pumps rank among the world’s top ten health technology hazards[1]. Efficiency is the key to minimizing the risks associated with infusion pumps, thereby enhancing patient safety and improving clinical workflow.

Mindray BeneFusion e Series streamlines workflow via a 3.5″ colored capacitive touchscreen, which features an intuitive UI for smooth touch operation. Fast preparation is also made possible using SmartRapid™ technology, which significantly shortens start-up time to less than 10 seconds from being switched on to administering the first drop of medication.

Meanwhile, the SafeDose™ drug management system enhances efficiency with color-coded visualizations to assist users in easily selecting and verifying the correct drug for treatment, and prevents dosing errors with hard or soft limit restrictions. For unexpected circumstances, the Dynamic Pressure System’s speedometer-style indicator helps medical staff monitor the in-line pressure trend at a quick glance, and provides a visual alert for a possible occlusion before interrupting the infusion.

When it comes to efficiency in safety, BeneFusion e Series supports stable and seamless infusions with a smooth automatic multi-channel relay. The eVP models are also equipped with SmartAIR™ technology, a dual sensor design that enhances the safety level of IV administration by detecting air bubbles more precisely.

In addition, Mindray BeneFusion e Series brings efficiency in application and informatics. The BeneFusion eSP and eVP’s all-in-one design satisfies various infusion purposes by integrating blood transfusion, TCI/TIVA, Nutrition, PCA and Neonatal application functions into one system, while the flexible modular docking design of the eDS supports tool-free expansion up to 16 slots. All of these infusion systems can be linked to BeneVision CMS™, which offers efficient one-stop monitoring of all patients’ vital signs and infusion treatment details to improve the quality of care.

Phillips-Medisize, a Molex company, and leader in the design, development, and manufacturing of drug delivery, diagnostic, and MedTech devices, collaborates with Subcuject, a global innovator of proprietary device platforms, to bring a ground-breaking wearable bolus injector to market. The On-Body Delivery System technology, based on osmosis, is now available for the next stage of drug-specific wearable injector solution development following Subcuject’s intellectual property filing of the concept.

“We are very pleased to collaborate with Phillips-Medisize to complete the development and manufacturing needed to bring our product innovation to pharma customers successfully,” said Jesper Roested, CEO of Subcuject. “Together, we can address the emerging need for inexpensive, prefilled, and single-use injectors that can deliver drugs at about 1mL per minute.”

The new Wearable Osmotic Bolus Injector is designed to be a low-cost, patient-friendly, prefilled wearable injector for single-use. The product uses osmosis to generate the force to complete a full injection cycle, requiring minimal components, which reduces development time and costs. Moreover, no additional electronics or batteries are required, resulting in further cost reductions and a lower environmental impact. Subcuject’s management team and board have decades of experience and a track record in MedTech, pharma, and drug delivery.

“Teaming with Subcuject to develop an affordable, versatile wearable injector leverages our combined strengths and global expertise in proprietary device platforms,” said Paul Chaffin, president of Phillips-Medisize. “We’re excited to develop the technology and pave the way toward commercialization.”

Additionally, Subcuject and Phillips-Medisize are exploring the opportunity to meet the growing demand for larger-volume drug delivery. The device will enable patients to self-administer certain medications almost anywhere, instead of requiring healthcare professionals to do so in a clinical setting.

“The urgent demands for quality and affordable patient care are driving momentum across the entire drug-delivery sector, including the wearable injector segment,” said Paul Jansen, a leading drug-device consultant and Subcuject board member. “The collaboration between Phillips-Medisize and Subcuject combines technology innovation, proven engineering, and manufacturing expertise to speed and scale the realization of this exciting new product.” Founded in 2017, Denmark-based Subcuject is a technology development company focused on developing an innovative and proprietary device platform for wearable bolus injection. The company is backed by Danish venture funds VF Venture and Capnova.

Phillips-Medisize: End-to-End Expertise

For more than 80 years, Phillips-Medisize has engaged with leading Healthcare and Life Science companies to develop innovative products that help people live healthier, more productive lives. The company’s unique end-to-end capabilities, from design and development, to global manufacturing, allow Phillips-Medisize to accelerate time to market while driving significant cost efficiencies. On average, Phillips-Medisize commercializes 50 new products a year for customers, including the first-to-market FDA-registered drug-delivery device utilizing a connected health system.

Jumio, the leading provider of AI-powered end-to-end identity verification and eKYC solutions, announced the appointment of three new members to its leadership team, following a landmark year which saw it reach record sales revenues, sign a number of marquee customers, make a key acquisition and realize strong returns on its 2020 channel focus.

Mark Reeves, appointed as Jumio’s new vice president of EMEA revenue, has more than 30 years of experience in scaling operations, building high-growth teams and disrupting industry practices across the theater. Reeves joins to head up revenue operations across EMEA following an incredibly successful run building Carbon Black, a leader in cloud-native endpoint protection, through an IPO and subsequent acquisition by VMWare. Prior to Carbon Black, Mark held EMEA and international leadership positions at Entrust, Mimecast, Promethean and RSA/EMC.

At Jumio, Reeves will be based in London and will focus on the continued expansion of the company’s new business, working closely to grow its current customer base and align support services to delight customers. He will also oversee the expansion of Jumio’s regional channel program to capitalize on the significant growth of its partner base over the last year.

Alongside Reeves, Jumio has also appointed Micah Willbrand as VP of product for AML services. Willbrand also brings extensive experience to Jumio as a strategic and operational leader for some of the industry’s marquee brands, including Experian, NICE Actimize, RELX and GB Group, in anti-money laundering, risk management, identity and authentication solutions. Willbrand will oversee the integration and expansion of the Beam Solutions AML platform acquisition as it is adopted by Jumio customers and channel partners.

Lastly, Jumio welcomed Mike Ruiz as director of Western U.S. sales. Ruiz brings more than 15 years of leadership experience from GridGain where he ran enterprise sales and Informatica where he ran Western U.S. sales through hypergrowth from $180 million to over $1.1 billion. Ruiz will hire new business executives and continue to expand Jumio’s successful partner base across the region.

“I’m thrilled to welcome Mark, Micah and Mike to the Jumio team,” said Dean Hickman-Smith, Jumio’s chief revenue officer. “Together, they will help us continue to build upon our tremendously successful 2020, further expanding across EMEA and North America and layering in incremental platform-based AML services. This in conjunction with expanding our channel footprint will fuel our continued growth as we help organizations make their commercial ecosystems and the internet a safer place.”

About Jumio

When identity matters, trust Jumio. Jumio’s mission is to make the internet a safer place by protecting the ecosystems of businesses through a unified, end-to-end identity verification and eKYC platform. The Jumio KYX Platform offers a range of identity proofing and AML services to accurately establish, maintain and reassert trust from account opening to ongoing transaction monitoring.

Leveraging advanced technology including AI, biometrics, machine learning, liveness detection and automation, Jumio helps organizations fight fraud and financial crime, onboard good customers faster and meet regulatory compliance including KYC, AML and GDPR. Jumio has verified more than 300 million identities issued by over 200 countries and territories from real-time web and mobile transactions. Jumio’s solutions are used by leading companies in the financial services, sharing economy, digital currency, retail, travel and online gaming sectors. Based in Palo Alto, Jumio operates globally with offices in North America, Latin America, Europe and Asia Pacific and has been the recipient of numerous awards for innovation.