Insulet Received FDA Clearance for its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control

On January 28, 2022, Insulet Corporation, a market leader in developing tubeless insulin pumps with its product, Omnipod®, received the FDA approval for its Omnipod® 5 Automated Insulin Delivery System (Omnipod 5). The system is designed for individuals aged six-year and above with type 1 diabetes. It is the first tubeless automated insulin delivery system that is compatible with smartphones and combines with the Dexcom G6 Continuous Glucose Monitoring (CGM) System to automatically adjust insulin and help protect against highs and lows.

The Omnipod 5 System consists of the tubeless Pod enhanced with SmartAdjust™ technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user has the option to either download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, which is provided free with the first prescription. It is designed to simplify diabetes management by eliminating the need for multiple daily injections, tubes, and fingersticks.

Shacey Petrovic, President and Chief Executive Officer of Insulet, said, “Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes. We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management, and improve glucose control for our users.”

“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system. Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range,” said Kevin Sayer, Chairman, President, and CEO of Dexcom.

According to DelveInsight’s ‘Insulin Delivery Devices Market” Report, the global Insulin Delivery Devices Market was valued at USD 14.23 billion in 2020, growing at a CAGR of 9.23% during the forecast period from 2021 to 2026, to reach USD 24.13 billion by 2026. The rise in demand for Insulin Delivery Devices is predominantly attributed to the rise in diabetes prevalence among the geriatric population, favorable reimbursement scenarios, rising awareness about proper diabetes management and insulin delivery devices, and technological advancement in the product line, among others.

Artivion Declared On-X® Mitral Heart Valve PROACT Study Results in The Annals of Thoracic Surgery

On January 31, 2022, Artivion, Inc., a medical devices company focused on developing solutions to meet the challenges faced by cardiac and vascular surgeons in treating patients with aortic diseases, declared the results of PROACT clinical trial with the title “Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial” in the Annals of Thoracic Surgery, the official journal of The Society of Thoracic Surgeons. 

The On-X Mechanical Heart Valve PROACT clinical trial was a two-armed, multicenter, non-inferiority trial to determine the safety of lower-intensity warfarin plus aspirin in patients with an On-X mechanical mitral valve replacement (MVR). After On-X mechanical mitral valve replacement followed by at least 3 months of standard anticoagulation, 401 patients at 44 North American centers were randomized to low-dose warfarin (target INR 2.0 to 2.5) or standard-dose warfarin (target INR 2.5 to 3.5). All patients were prescribed 81 mg aspirin daily and encouraged to use home INR testing. Mean patient follow-up was 4.1 years with a maximum follow-up of 8 years. No differences in bleeding, valve thrombosis, or thromboembolism rates were observed between patient groups treated with low-dose vs standard-dose warfarin. This study demonstrates that a lower target INR is safe and feasible for patients with an On-X mechanical valve in the mitral position. The FDA is currently reviewing the labeling change recommendation for the On-X mechanical mitral valve based on this clinical trial.

Pat Mackin, Chairman, President, and CEO of Artivion, Inc., commented, “The PROACT Mitral results add to the data from clinical trials we have sponsored showing that patients with our On-X heart valves can be safely maintained with lower anticoagulation levels than required for competitors’ mechanical valves. We continue investing in scientific studies to improve and simplify the lives of prosthetic heart valve patients. In addition, the ongoing PROACT Xa trial aims to prove that patients with the On-X aortic valve can be safely maintained on apixaban, without the need for routine anticoagulation blood tests.”

“This randomized trial has very important and reassuring findings for patients with unrepairable mitral valve disease. Patients with an On-X mechanical mitral valve can be reassured that a lower INR target is safe, without any increased risk of blood clots or stroke, which may help to alleviate some of the concerns with anticoagulation management with a mechanical valve. We believe this research represents one of the most important advances in the clinical management of mechanical mitral valves over the past 2 decades and will potentially have important practice and guideline-changing implications. We are proud to have presented it at the Society of Thoracic Surgeons Annual Meeting along with simultaneous publication in The Annals of Thoracic Surgery.”, said Michael W. A. Chu, M.D., FRCSC, Chair/Chief of Cardiac Surgery at London Health Sciences Centre, Western University, London, ON, Canada, and lead author for the PROACT mitral clinical trial.

According to DelveInsight’s “Transcatheter Mitral Valve Repair Devices MarketReport, Abbott Laboratories, Cardiac Dimensions Europe GmbH, Edwards Lifesciences Corporation, CryoLife Inc, Neovasc Inc., Medtronic, On-X Life Technologies, Inc, Lepu Medical, among others are some of the key players developing the transcatheter mitral valve repair devices.

FDA Granted Approval to World’s First Credit-Card-Sized Personal ECG

On February 01, 2022, AliveCor, the leading developer of personal electrocardiogram (ECG) technology, received FDA clearance for the slimmest, most convenient personal ECG device, KardiaMobile Card, and also announced its launch. KardiaMobile Card is of a standard credit card size that fits easily into any wallet and delivers a medical-grade, single-lead ECG in 30 seconds. This ECG device pairs with a smartphone using Bluetooth technology to detect six of the most common arrhythmias, more than any other personal ECG on the market. The algorithm of the device is based on AliveCor’s AI-enabled Kardia technology, which has been evaluated by more than 170 peer-reviewed studies. KardiaMobile Card is the most portable and durable ECG available as it resists weather, water, and wear & tear, allowing users to take an ECG recording anytime, anywhere.

Priya Abani, CEO of AliveCor, said, “After disrupting traditional ECG monitoring with our game-changing Kardia platform, we have now achieved the unprecedented milestone of creating the first-ever credit-card-sized personal ECG. KardiaMobile Card delivers the most sophisticated AI in the most convenient form factor ever, putting the power of real-time ECG analysis directly in patients’ wallets and furthering our vision of becoming the 24/7 virtual cardiologist for patients when they’re not in front of their physician.”

Darria Long Gillespie, MD, emergency physician and Clinical Assistant Professor of Emergency Medicine, AliveCor Ambassador and founder of the TrueveLab, said, “The availability of a personal ECG that fits in a wallet will change the face of remote cardiac monitoring for patients and healthcare professionals alike. As someone who lives with ventricular tachycardia and has treated patients with arrhythmias, I know how critical it is to access accurate ECG recordings in real-time. KardiaMobile Card has made this technology even easier to access, and it has quickly become the most valuable card in my wallet.”

According to DelveInsight’sECG Monitoring Equipment – Market Insights, Competitive Landscape, and Market Forecast-2026″, the global Electrocardiogram (ECG) Monitoring Equipment Market was valued at USD 4.20 billion in 2020, growing at a CAGR of 5.73% during the forecast period from 2021 to 2026, to reach USD 5.87 billion by 2026. The demand for Electrocardiogram (ECG) Monitoring Equipment is primarily being boosted by the rising prevalence of cardiovascular diseases, technological advancement in product development, increasing geriatric population, sedentary lifestyle, and increasing awareness regarding cardiovascular diseases. In addition, as per Delveinsight’s analysis, the Holter monitors segment is expected to amass the largest market share during the forecast period. Holter monitors have been the most commonly used device to detect abnormal heart functioning in patients. They also help in diagnosis and in maintaining the normal functioning of the heart. These devices are generally found in hospitals setups and have been the conventional and most preferred mode of ECG monitoring of patients.

BD Board of Directors Approved the Spinoff of embecta and Declares Distribution of embecta Stock

On February 01, 2022, BD (Becton, Dickinson, and Company), one of the largest global medical technology companies, declared that its board of directors has approved the planned spinoff of its diabetes care business, which will be known as Embecta Corp. (“embecta”). The company also declared a pro-rata distribution of all of the outstanding shares of embecta common stock to BD shareholders. The board voted unanimously to approve the spinoff to occur on April 1, 2022. Upon the completion of the distribution, embecta will be an independent, publicly-traded company focused on diabetes management, and BD will retain no ownership interest.

Tom Polen, chairman, CEO, and president of BD said, “Since the announcement of our intention to spin off the diabetes care business, teams across BD have been working diligently to prepare for successful separation of the two companies, and the Board is pleased with their progress and satisfied that embecta is ready to serve its customers and drive higher growth as an independent organization. We expect both BD and embecta to drive greater long-term value for shareholders while delivering impactful solutions that improve the future of health care.

The board approval is a significant milestone, and our team is eager to build upon our nearly 100-year legacy of developing innovations that help people with diabetes live a better life.”, said, Devdatt “Dev” Kurdikar, who will be CEO of embecta upon completion of the spinoff.

According to DelveInsight’s ‘Diabetes Market Insight” Report, Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Moreover, as per the CDC 2020 highlights, the percentage of adults with diabetes increased with age, reaching 26.8% among those aged 65 years or older in the US.

OmnySense and Wolfson Medical Center Commenced Smart Thermometer Clinical Trial

On February 01, 2022, Omny Sense, an Israel-based startup company, and Wolfson Medical Center, a leading Israeli hospital initiated a clinical trial to evaluate the use of OmnySense technology to monitor and analyze respiratory sounds as recorded at the mouth. The company’s technology is a next-generation smart-thermometer that measures multiple parameters as part of an integrated device/cloud Digital Health information system. This thermometer-shaped device is integrated with an in-mouth microphone that detects respiratory sounds and transmits them to the cloud for analysis using the company’s algorithms, to detect and analyze lung sounds indicating medical conditions. Vital signs and other parameters measured by the current version of the device include temperature, ECG, pulse rate, respiratory rate, respiratory sounds, and blood oxygenation – enabling a remote medical team to remotely track the health condition of patients at home.

The clinical trial started with a proof of concept, and is currently the testing of patients is underway. In this trial, the respiratory sounds as detected by the standard stethoscope are being compared with the sounds detected by the OmnySense devices stethoscope at 10 locations on the chest and the back of the patients.

Dr. Menachemi explained, The objective of the trial is to map the lung sounds as detected by a stethoscope to the sounds detected by the OmnySense device. If successful, this will constitute a major step towards enabling remote analysis of the respiratory condition of patients at home, where the patient just uses a simple thermometer-shaped device.”

According to DelveInsight’s “Vital Sign Monitors/External Remote Patient Monitoring Devices – Market Insights, Competitive Landscape, and Market Forecast-2026”, the global vital sign monitors market was valued at USD 7.59 billion in 2020, growing at a CAGR of 7.94% during the forecast period from 2021 to 2026, to reach USD 11.97 billion by 2026. The rise in demand for vital sign monitors is primarily attributed to the growing burden of the old age population across the globe, increase in the prevalence of a variety of lifestyle-associated disorders such as respiratory disorders, cardiology disorders, among others. Moreover, constant efforts of the key manufacturers for developing technologically advanced vital sign monitoring devices, and the rise in approval of the products portfolio, among others are the factors responsible for the growth of vital sign monitoring devices. In addition, as per Delveinsight’s analysis, the standalone monitoring devices which are further sub-categorized into blood pressure monitoring devices, pulse oximeters, temperature monitoring devices, and others are expected to hold a significant market share during the forthcoming years. This is due to the wide availability of standalone devices in the market. Moreover, the standalone remote vital sign monitoring devices are available Over the Counter (OTC) which also increases the segmental market for vital sign monitors.

Medtronic Declared First Procedure in Europe with Hugo™ Robotic-Assisted Surgery System

On February 02, 2022, Medtronic plc., a key market leader in healthcare technology, and OLV Hospital Aalst declared the first clinical procedure performed with Hugo™ robotic-assisted surgery (RAS) system in Europe. Prof. Alexandre Mottrie, M.D., head of urology at OLV Hospital in Aalst, Belgium performed the robotic prostatectomy.

The Hugo RAS system — Medtronic’s Hugo RAS system is a modular, multi-quadrant platform designed for a broad range of soft-tissue procedures. It combines wristed instruments, 3D visualization, and Touch Surgery™ Enterprise, cloud-based surgical video capture and management solution, with dedicated support teams specializing in robotics program optimization, service, and training. The system was used for urologic and gynecologic procedures in Latin America and the Asia Pacific in the year 2021.

The Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo RAS system is CE marked. In Canada, the Hugo RAS system has a medical device license. The Hugo RAS system is approved in Australia. However, in the US, the Hugo RAS system is an investigational device not for sale.

Performing Europe’s very first procedure with the Hugo RAS system is a career highlight for me. With more than two decades and 4,000 robotic-assisted surgery procedures under my belt, I am intimately aware of the barriers that have kept the benefits of surgical robotics from physicians, hospitals, and patients. Now, I believe we are entering a new era filled with greater access and flexibility.” said, Dr. Mottrie.

Henk Westendorp, senior country director Benelux at Medtronic, said, “The Hugo RAS system introduces the long-awaited power of choice in the category and will redefine all that robotic-assisted surgery can make possible. Medtronic thoughtfully designed the Hugo RAS system with surgeons in mind and patients at heart to tackle today’s barriers to adoption in a future-proofed way. We know that by innovating real solutions for the way surgeons want to work — alongside partners like OLV Hospital Aalst who share our passion for advancing patient care — we can make a substantial impact.”According to Delveinsight’s Surgical Robotic System – Market Insight, Competitive Landscape, and Market Forecast – 2026″, the Surgical Robotic Systems Market is witnessing a surge in product demand due to the growing popularity of minimally invasive procedures. Even though open surgeries are still a norm, the disadvantages associated with open surgery such as the increased risk of procedural complications, longer healing time acted as a catalyst in the development of minimally invasive Surgical Robotic Systems. Surgical robots offer accuracy, stability, integration with modern imaging technology, greater range of motion, telesurgery, in addition to multiple other benefits exclusive to individual surgical specialties.