Institute for Accountable Care Director: Home Health Providers, ACOs Need to Get on Same Page

homehealthcarenews | July 10, 2019

For many Accountable Care Organizations (ACOs), having a strong presence in the home has been a vital strategy for improving care management and identifying patient needs. Even so, many ACOs carry out that strategy with in-home visits from primary care practitioners - and not necessarily dedicated home health providers.

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The National Health Service Commissioning Board was established on 1 October 2012 as an executive non-departmental public body. Since 1 April 2013, the National Health Service Commissioning Board has used the name NHS England for operational purposes. The following organisations, listed alphabetically, have partnered with NHS England in developing this document. It should be noted that MHRA has only commented on regulatory aspects of the paper.


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HEALTH TECHNOLOGY

Vitestro unveils autonomous blood drawing device, combining artificial intelligence, ultrasound imaging and robotics

Vitestro | May 31, 2022

Vitestro, a Dutch medical robotics company, unveiled the world's most advanced autonomous blood drawing device at the annual meeting of the Netherlands Society for Clinical Chemistry and Laboratory Medicine in Rotterdam. Vitestro's device combines AI-based, ultrasound-guided 3D reconstruction with robotic needle insertion, ensuring accurate and secure blood collection. The venipuncture technology is adaptable to patients of 16 years of age onwards, comorbidities, and puncture difficulty. From 2023, Vitestro will initiate pivotal clinical studies for regulatory approval in Europe. EU-market introduction is anticipated in 2024. Healthcare shortages spark revolutionary developments Within healthcare, the clinical laboratory is the driving force. Accuracy and timeliness of laboratory tests are critically important, as they shape approximately 70% of all medical decisions made by physicians. It is unsurprising that blood collection is the most common invasive medical procedure, performed billions of times per year globally. Blood collection holds a pivotal role in clinical diagnostics yet is also burdened by the scarcity of skilled workers. By automating this labor-intensive procedure, we can transform the quality of care and create a sustainable healthcare system. Proprietary laboratory automation technology standardizes handling of the blood sample while the blood is collected. The device allows almost complete automation of the pre-analytical phase. This has the potential to reduce high blood test error rates, mainly caused by manual variability. In clinical studies, Vitestro already performed 1,500 automated blood draws in more than 1,000 patients with its prototype. Toon Overbeeke, Vitestro's Co-Founder and Chief Executive Officer said: "The mounting shortage of healthcare personnel is imminent. The pandemic has further led to loss of workforce, causing a bleak outlook for hospital output around the globe, and leading to reduced access and continuity of care. That's why revolutionary automation like our blood drawing device is inevitable to solve the industry's biggest problem." Outpatient phlebotomy care is redefined At first, Vitestro will implement the device in outpatient phlebotomy departments. Patients will have the option to choose between Vitestro's venipunture device or standard method. The device is intuitive to use, empowering patients to be self-reliant in the full blood collection procedure. In previous clinical trials, patients of all ages showed a high degree of openness, enthusiasm and willingness to adopt the innovation. A trained healthcare professional is able to supervise several devices, managing multiple patients simultaneously. The increased efficiency enables hospitals and clinical laboratories to address workforce shortage or even free up staff and deploy them where they are really needed. "We have spent nearly five years on the development of this breakthrough medical device. All relevant disciplines are represented in our dedicated, specialized team of 35 people. To prepare for production and commercialization, the team will double in size in the next two years. We have clear momentum in the market and will be the first to bring autonomous technology to European hospitals. With our technology we can help to build a more robust and resilient healthcare system." Toon Overbeeke, Vitestro's Co-Founder and Chief Executive Officer Anja Leyte, Director OVLG Laboratories, participating in clinical studies commented: "By introducing automated blood drawing, high quality as well as capacity is guaranteed in our laboratories. Vitestro's technology helps solving staffing shortages at our blood drawing department and improving sample standardization. Patients are also very enthusiastic." About Vitestro In 2017 Vitestro's founders rose to the challenge to create a better blood drawing experience. Today Vitestro is well underway to achieve its goal with a committed team of 35 highly skilled people with a track record in medical robotics, imaging software, AI, QA/RA and business development. Vitestro is based in Utrecht, the Netherlands. Vitestro is well funded by private investors and government subsidies.

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HEALTH TECHNOLOGY

Mednow Enters Into Agreement to Acquire Mednow East Inc in Ontario

Mednow Inc. | March 08, 2022

Mednow Inc. Canada’s on-demand virtual pharmacy, is pleased to announce that the Company has entered into a share purchase agreement on March 4, 2021 with Mednow East Inc.and the shareholders of Mednow East, pursuant to which the Company shall acquire all of the issued and outstanding shares of Mednow East, in consideration for an aggregate cash payment of approximately C$65,578 and the Company’s agreement to convert approximately C$1,374,422 owed by Mednow East to the Company pursuant to a pharmacy agreement dated September 15, 2020, as amended October 30, 2020 into a non-interest bearing on-demand convertible promissory note. Mednow East is an Ontario company that operates an online pharmacy, delivering prescriptions in the Province of Ontario. Mednow East has its business headquarters in Toronto and employs Mednow’s marketing and technology platform for lead generation, prescription fulfillment and customer services pursuant to the Pharmacy Agreement. Strategically, Mednow is focused on building out a national pharmacy footprint and the acquisition of Mednow East, with their presence in Ontario, helps to accelerate these goals. Prior to this acquisition, Mednow entered into the Pharmacy Agreement with Mednow East, but post-acquisition, Mednow will own 100% of a pharmacy located in Ontario, which will allow Mednow to provide free same-day pharmaceutical delivery services in the GTA and surrounding areas, and free next-day delivery in the rest of Ontario. Upon closing of the Share Purchase Agreement, Mednow East’s revenue and expenses will be consolidated with those of Mednow and the Pharmacy Agreement between the two parties will be terminated. The debt of approximately C$1,374,422 extended to Mednow East by the Company was used to fund Mednow East’s working capital and provide support for its operations. As Amir Ali Reyhany-Bozorg and Felipe Campusano are directors of the Company and Karim Nassar is the Chief Executive Officer of the Company, and each are also shareholders of Mednow East, the transaction contemplated under the Share Purchase Agreement is a related party transaction under Multilateral Instrument 61-101 –Protection of Minority Securityholders in Special Transactions. The Company is exempt from the formal valuation and minority shareholder approval requirements imposed by MI 61-101 pursuant to the exemptions in section 5.5(a) and 5.7(a) of MI 61-101, as neither the fair market value of the Shares, nor the consideration paid therefor, exceeds 25% of the Company's market capitalization. The Transaction is subject to corporate and regulatory approvals, including TSX Venture Exchange approval. About Mednow Inc. Mednow is a healthcare technology company offering virtual access with a high-standard of care. Designed with accessibility and quality of care in mind, Mednow.ca provides virtual pharmacy and telemedicine services as well as doctor home visits through an interdisciplinary approach to healthcare that is focused on the patient experience. Mednow’s services include free at-home delivery of medications, a user-friendly interface for easy upload, transfer, and refill of prescriptions, access to healthcare professionals through an intuitive chat experience, a specialized PillSmart™ system that packages prescriptions and vitamins by date and time, and doctor consultations.

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HEALTH TECHNOLOGY

Ivenix to be Acquired by Fresenius Kabi

Ivenix | April 01, 2022

Ivenix, Inc. announced that it has entered into a definitive agreement to be acquired by Fresenius Kabi, a global health care leader specializing in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Ivenix’s advanced infusion system combined with Fresenius Kabi’s intravenous fluids and infusion therapy offerings will bring a comprehensive portfolio of infusion products to U.S. hospitals. The purchase price will be a combination of US$240 million upfront payment and milestone payments linked to achievements of commercial and operating targets. The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022. The transaction is designed to Create a comprehensive portfolio that joins the industry’s most advanced infusion pump technology with the newest source of intravenous fluids, infusion supplies and accessories. Accelerate operational and commercial growth and scale providing a platform for rapid expansion. Build on a shared culture of exceptional customer service. Establish Fresenius Kabi as a leader in the approximately $5 billion infusion segment. This pivotal transaction will accelerate innovation, expand our combined infusion therapy portfolio and enhance our infusion capabilities, resulting in improved medication safety and operational efficiency. “We’re very pleased to partner with Fresenius Kabi, a leading global health care company. Together, we intend to transform the standard of care for North American health care providers and patients by providing the highest level of safe and effective integrated infusion care,” Jorgen B. Hansen, Ivenix’s Chief Executive Officer The Ivenix Infusion System includes a large-volume infusion pump with administration sets, infusion management tools, and analytics to inform care and advance efficiency. Ivenix centered the system around the patient and clinician and designed it to reduce infusion-related errors and drive down the total cost of ownership. After receiving U.S. Food and Drug Administration (FDA) clearance, Ivenix successfully launched the infusion system in 2021. “Combining Ivenix’s expertise in pump technology and software with our infrastructure, portfolio, and presence in hospital settings represents an ideal opportunity. We intend to scale the launch of Ivenix’s next-generation infusion system while driving growth opportunities in the United States. With today’s announcement, Fresenius Kabi expects to create a leading, comprehensive infusion therapy offering,” said Michael Sen, President and CEO, Fresenius Kabi. About Ivenix Ivenix, Inc. is a medical technology company with a vision to eliminate infusion-related patient harm. The company was founded to develop innovative solutions that transform infusion delivery. Ivenix designed an infusion system from the ground up to streamline medication delivery and bring infusion technology into the digital age. The Ivenix Infusion System includes a large-volume infusion pump supported by a robust infusion management system designed to set new standards in simplicity, intelligence, and reliability. For more information, visit ivenix.com. The Ivenix Infusion System is cleared by the FDA.

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DIGITAL HEALTHCARE

UniDoc Partners with AMD Global Telemedicine

UniDoc | February 04, 2022

UniDoc Health Corp., an innovator in the telehealth sector, is pleased to advise on a commercial master distribution agreement (the “Agreement”) with Massachusetts-based AMD Global Telemedicine Inc. (“AMD Global”) for the provision of specialized products and services critical to ongoing commercialization efforts. As a pioneer of virtual care technology, and an industry leader in telehealth solutions, AMD Global has been providing quality healthcare solutions for over 30 years with product sales and registered deployments in 100+ countries. The agreement adds AMD Global as a UniDoc key supplier of telehealth solutions including virtual care software platforms, integrated medical devices, and telemedicine bundled kits. The products and services will be purposed and integrated into the UniDoc Virtual Care Solutions Model (“VCSM”), which will offer a proprietary, customizable, and comprehensive telehealth solution based on a variety of integrated physical enclosures, kiosks, and related configurable packaging designed to deliver web-based services and analytical tools in combination with access to a developing network of healthcare providers, pharmacies, and hospitals. All AMD Global products and telehealth technologies are built to provide high performance and quality, are easy to use and maintain, and operate dependably even in difficult environments. AMD Global is ISO 13485:2003 certified and runs an FDA registered facility operating within good manufacturing telemedicine best practices guidelines. The AMD platform provides UniDoc with immediate access to FDA & Health Canada approved devices (FDA Certified; ISO 13485; and FDA GMP – including all HIPPAA privacy and compliance) which support and help propel the Company’s fast-track plans for commercialization. Mr. Eric Bacon, President of AMD Global Telemedicine Inc. states, we are very pleased to have this opportunity to work with the UniDoc team. Their dedication, passion and commitment are outstanding and adds great value to their ability to drive ahead, overcome obstacles, and keep focused on achieving results. Their offering is unique in its vision and feasibility to scale. We are excited to have been chosen as UniDoc’s provider of choice for their telehealth technology needs today as well as help them extend and develop their telehealth portfolio going forward.” “We are so very delighted to have this opportunity to work with AMD Global as a key vendor of critical components and services. When we began this venture, we found a very short list of suppliers who so clearly fit our needs and timelines. It didn’t take long to determine that AMD’s medical grade instruments are integrated into high quality software. Additionally, AMD completely met our needs when it came to ensuring all required certification and compliance requirements were already in place. To everyone’s credit on both sides, the synergies were readily apparent, and it didn’t take long to come to an agreement. I’m confident that this arrangement will prove instrumental in unlocking the value of this exciting venture together.” UniDoc CEO Antonio Baldassarre About UniDoc Health Corp. UniDoc is developing a telehealth solution which is being designed as a self-contained remote virtual clinic within a private kiosk for patients to undergo full consultations as if they were present in a physician’s office. Telehealth opens the doors to a large segment of the population challenged by access, experience or understanding of online computer technology. It is the Company’s belief that physical accessibility is the key to its business proposition. UniDoc is dedicated to unlocking shareholder value by delivering an excellent product and sophisticated commercial network within an expedited timeframe.

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Spotlight

The National Health Service Commissioning Board was established on 1 October 2012 as an executive non-departmental public body. Since 1 April 2013, the National Health Service Commissioning Board has used the name NHS England for operational purposes. The following organisations, listed alphabetically, have partnered with NHS England in developing this document. It should be noted that MHRA has only commented on regulatory aspects of the paper.

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