When iLet users “GO BIONIC” with their diabetes care, there is no need to count carbs* or calculate insulin corrections during the day; the iLet determines 100% of insulin dosages and continuously learns and adapts to the user. The user’s weight is the sole input required to start using the iLet.
“Beta Bionics continues to move at lightning speed to bring these enhancements to our userbase,” said Sean Saint, CEO of Beta Bionics. “With our recent launch of the Bionic Circle remote monitoring app, our latest updates to the iLet app, and today’s launch of the iLet integration with Abbott’s FreeStyle Libre 3 Plus sensor, we are focused on providing major product enhancements to make diabetes management even easier for our users and their families.”
The Beta Bionics Bionic Circle App lets users invite up to ten friends and family members to monitor their CGM levels and insulin doses remotely. Bionic Circle members can get alerts and see an iLet user’s glucose levels, meal announcements, insulin dosages, and trends all day and night.
This integration gives users a new option to control type 1 diabetes. With both Beta Bionics and FreeStyle Libre’s capacity to sell products through the pharmacy channel, users of the integrated platform can benefit from the convenience of purchasing supplies through an innovative pay-as-you-go model.
As per DelveInsight’s “Insulin Delivery Devices Market Report”, the global insulin delivery devices market was valued at USD 15.51 billion in 2023, growing at a CAGR of 9.28% during the forecast period from 2024 to 2030, to reach USD 26.35 billion by 2030. The rise in demand for insulin delivery devices is predominantly driven by the increasing prevalence of diabetes due to lifestyle changes, aging populations, and genetic factors. Secondly, awareness campaigns and educational initiatives have significantly increased public knowledge about diabetes management. Patients and healthcare providers are now more informed about the benefits of using advanced insulin delivery devices, which offer precise dosing, convenience, and improved blood glucose control compared to traditional methods. Technological advancements have also fueled market growth by introducing innovative features such as smart insulin pumps, continuous glucose monitor (CGM) integration, and mobile app connectivity. Collectively, these factors create a robust market environment that drives the demand for insulin delivery devices, ensuring better health outcomes for diabetes patients, during the forecast period from 2024 to 2030.
Merit Medical Completed the Acquisition of the Lead Management Portfolio from Cook Medical
On November 1, 2024, Merit Medical Systems, Inc., announced that it finalized the acquisition of Cook Medical’s lead management portfolio.
The purchase cost included a cash payment of about USD 210 million and the assumption of certain liabilities. Merit paid the acquisition price with a combination of cash on hand and borrowings from its long-term credit facility.
Cook Medical’s lead management division offers a complete line of medical devices and accessories used in lead management procedures for patients who require the removal or replacement of a pacemaker or an implanted cardioverter-defibrillator lead.
Merit’s electrophysiology and CRM portfolio, in addition to the lead management portfolio purchased from Cook Medical, comprises steerable and other specialist technologies that assist electrophysiologists in accessing the heart to diagnose and deliver cardiac rhythm problem treatments.
“We are pleased to announce the completion of this important acquisition,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are excited to welcome the talented team from Cook Medical’s lead management business. We believe this acquisition will strengthen our fast-growing, high-margin electrophysiology and CRM business, as well as enhance our position in the global cardiac intervention market.”
As per DelveInsight’s “Electrophysiology Devices Market Report”, the electrophysiology devices market was valued at USD 6.31 billion in 2023, growing at a CAGR of 9.73% during the forecast period from 2024 to 2030, to reach USD 9.22 billion by 2030. The electrophysiology devices market is growing significantly due to the increasing cases of chronic disorders such as cardiovascular diseases including atrial fibrillation and coronary artery disease (CAD) with the rising shift towards minimally invasive approaches, innovative product developmental activities by leading companies, and rising geriatric population which are expected to escalate the to the overall growth of the electrophysiology devices market during the forecast period from 2024 to 2030.
LithiX HC-IVL System by Elixir Medical’s Demonstrated Sustained Safety and Efficacy at Six Months
On October 30, 2024, Elixir Medical’s LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) was found to be safe and effective for treating moderate to severely calcified coronary artery lesions in the PINNACLE I research after six months of use.
The revolutionary LithiX Hertz Contact IVL system is the first non-energy IVL device developed to fragment moderate to severe calcified lesions that are refractory to optimal stent expansion. The LithiX IVL mechanism of action is based on the physics principle of Hertz Contact Stress, which propagates the required discrete forces to fragment calcium without causing vessel injury, requires no energy source or capital equipment, and has a positive impact on PCI procedure workflow by shortening procedure times and simplifying the learning curve.
LithiX data results demonstrated:
- 98.3% clinical success (primary effectiveness and safety outcome) with 100% angiographic success over a range of moderate to severe calcium morphologies.
- All lesions had a residual diameter stenosis of less than 30%.
- There were no angiographic problems, such as severe dissections, perforation, or abrupt closure after stenting.
- The procedure was safe and effective, with just one peri-procedural non-Q-wave myocardial infarction and a 1.7% TLF event rate over 6 months.
An intravascular imaging sub-study with optical coherence tomography (OCT) was carried out to precisely measure the lesion complexity and calcium fragmentation efficiency of LithiX IVL across a variety of complicated calcium shapes.
“The cardiology community has long sought solutions that can better treat patients with calcified lesions to achieve optimal PCI outcomes,” said Johan Bennett, M.D., study principal investigator and director of CTO/CHIP program at the University Hospital Leuven in Leuven, Belgium. “The six-month PINNACLE I data are a strong validation of LithiX IVL’s mechanism of action that can safely fragment calcium across a range of complex morphologies without trauma to the soft tissue and can be easily integrated into standard PCI procedure workflow without the need for an energy source.”
“We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.”
According to DelveInsight’s “Lithotripsy Devices Market Report”, the lithotripsy devices market was valued at USD 1.39 billion in 2023, growing at a CAGR of 4.32% during the forecast period from 2024 to 2030 to reach USD 1.78 billion by 2030. The lithotripsy devices market is growing significantly due to the rising prevalence of urolithiasis, technological advancements in product development, increased risk of end-stage renal failure, and rising awareness for the procedure is expected to escalate the demand for lithotripsy devices during the forecast period from 2024 to 2030.
Philips Enrolled the First Patient in the U.S. Clinical Trial for Innovative Integrated Single-Device to Treat Peripheral Artery Disease
On November 4, 2024, Royal Philips, announced the enrollment of the first patient in the U.S. THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy catheter developed by Philips, that integrates two critical PAD treatments into a single device.
Procedures that previously required the use of two different devices can now be completed in a single procedure with a single device, simplifying workflows and procedures and potentially lowering risk and increasing results for patients who would otherwise require multiple difficult interventions.
The purpose of this pivotal study is to assess the safety and efficacy of using this novel laser device, which combines laser atherectomy and intravascular lithotripsy in a single device, to treat complex, calcified lesions in a single procedure for patients with peripheral artery disease (PAD), restoring blood flow to their legs.
“Developing and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system,” said Drs. Craig Walker, Pradeep Nair, and McCall Walker of Cardiovascular Institute of the South in Louisiana. “This trial will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions.”
The prospective, single-arm, multicenter trial will include up to 155 patients from up to 30 sites in the United States. The study, which is being conducted under an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA), will evaluate the system’s safety and effectiveness in attaining procedural success while minimizing problems.
The study’s primary endpoints include the absence of major adverse events (MAEs) such as mortality, unplanned amputations, and clinically driven target lesion revascularization (CD-TLR) within 30 days (about four and a half weeks) of the procedure, as well as the achievement of less than or equal to 50% residual stenosis post-procedure. Patients will be monitored for twelve months.
“This innovative approach to vessel preparation could improve patient outcomes while minimizing the need for multiple therapies and interventions. That makes this an exciting innovation milestone as we enroll the first patient in this important U.S. clinical trial,” said Dr. Genovese, MD, vascular surgeon and co-principal investigator of the THOR* trial at the Penn Advanced Limb Preservation, Hospital of the University of Pennsylvania. “Integrating atherectomy and intravascular lithotripsy into a single device has the potential to revolutionize the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications.”
According to DelveInsight’s “Atherectomy Devices Market Report”, the global atherectomy devices market was valued at USD 939 million in 2023, growing at a CAGR of 9.24% during the forecast period from 2024 to 2030 to reach USD 1,596 million by 2030. The demand for atherectomy devices is primarily being boosted by the increasing geriatric population, rising prevalence of cardiovascular diseases, growing prevalence of lifestyle disorders such as hypertension and diabetes, and innovation in product development thereby contributing to the overall growth of the atherectomy devices market during the forecast period.
iRhythm Technologies Received FDA 510(k) Clearance for Design Modifications for Zio® AT Device
On October 30, 2024, iRhythm Technologies, Inc. stated that the US Food and Drug Administration (FDA) approved its 510(k) filing for design changes and labeling updates for the Zio AT device. Zio AT remains commercially accessible for shipment to clients in the United States, and product upgrades under this 510(k) clearance will be available in 2025.
The Zio AT gadget is designed to capture and transmit both symptomatic and asymptomatic cardiac events, as well as record continuous electrocardiogram (ECG) data for long-term monitoring. It is recommended for individuals 18 and older who are asymptomatic or have temporary symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, syncope, weariness, or anxiety. It is not intended for use with critical care patients.
The Zio AT device is a prescription-only outpatient cardiac telemetry device, often known as a mobile cardiac telemetry device, that is used to deliver our mobile cardiac telemetry (MCT) services. The Zio AT system consists of three components: the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days; the wireless gateway, which connects the Zio AT patch to the Zio ECG Utilization Software (ZEUS) and transmits data during the wear period; and ZEUS, iRhythm’s deep-learning algorithm that analyzes cardiac events transmitted by the Zio AT patch and gateway.
The Zio AT services give event transmission reports during wear, as well as a comprehensive end-of-wear report1-4 with preliminary findings for the treating medical professional to make final therapeutic decisions.
“This clearance is related to enhancements to our Zio AT product, including design features and labeling updates intended to address areas of concern specific to Zio AT that were noted in a 2023 FDA warning letter to the Company,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We believe these features that were subject to this clearance advance our technology for the benefit of patients, physicians, and healthcare systems who rely on our Zio AT services. At all times, we remain committed to patient safety, physician trust in Zio AT’s clinical performance, service quality, and regulatory compliance.”
According to DelveInsight’s “ECG Telemetry Devices Market Report”, the global ECG telemetry devices market is estimated to grow at a CAGR of 7.29% during the forecast period from 2024 to 2030. The demand for ECG telemetry devices is primarily being boosted by the rising prevalence of coronary heart disease across the globe. Further, the rising cases of patients with chronic diseases, the increasing patient admission in intensive care, increasing awareness about self-assessment of heart rhythm, increasing demand for telemedicine, and innovation in product development among others are thereby contributing to the overall growth of the ECG telemetry devices market during the forecast period from 2024-2030.
SeeMedX Filed 510(k) with the FDA for an Innovative Cardiac Monitoring System to Transform Heart Failure Care
On November 4, 2024, SeeMedX Inc., announced that it submitted a 510(k) premarket notification to the United States Food and Drug Administration (FDA) for its innovative, non-invasive cardiac monitoring device, which is designed to provide medical professionals with real-time insights into cardiac performance and fluid status.
SeeMedX’s technology enables clinicians to make more educated decisions about heart failure treatment, resulting in faster and safer outcomes than current options. SeeMedX’s non-invasive cardiac gadget measures accurate hemodynamic parameters such as Zo (fluid status) and CO (cardiac output), allowing clinicians to detect volume overload and other heart failure signs earlier than traditional approaches.
It provides actionable data on Zo (fluid status) and CO (cardiac output), allowing clinicians to make more prompt decisions for optimal heart failure treatment. It also improves patient comfort and clinical efficiency by being non-invasive, allowing for faster treatments, increasing hospital efficiency, and enabling prompt clinical choices.
“This submission marks a major milestone for SeeMedX in advancing heart failure care,” said Deborah Simpson, CEO of SeeMedX. “After the unexpected loss of my father, I made it my personal mission to develop a life-changing solution for heart failure treatment. Our goal is to empower clinicians with tools that ultimately improve outcomes for patients everywhere.”
According to DelveInsight’s “Cardiac Monitoring Devices Market Report”, the cardiac monitoring device market is estimated to grow at a CAGR of 5.4% during the forecast period from 2024 to 2030. The cardiac monitoring device market is observing substantial market growth primarily owing to the increasing cases of chronic disorders such as cardiovascular diseases including atrial fibrillation and coronary artery disease (CAD) with the rising shift towards minimally invasive approaches, innovative product developmental activities by leading companies, and rising geriatric population are expected to escalate the overall growth of the cardiac monitoring devices market during the forecast period from 2024 to 2030.
