Laborie Launched Solar Compact System and Solar Anorectal Manometry Catheter for Enhanced Gastrointestinal Diagnostics

On May 20, 2024, Laborie Medical Technologies Corp., launched the Solar Compact System and Solar Anorectal Manometry Catheter, the first disposable HRAM catheter on the market. These devices significantly advance diagnostic capabilities for defecatory disorders and pelvic-floor dysfunction associated with constipation and fecal incontinence by measuring static and dynamic pressures in the lower gastrointestinal tract.

Anorectal manometry, a diagnostic procedure for assessing pressures in the anus and rectum, is conducted by different healthcare providers and is crucial for diagnosing gastrointestinal ailments. The Solar Catheter, a disposable device with 10 air-charged channels for high-resolution anorectal manometry, integrates smoothly with the reusable Solar Charger to deliver precise pressure readings in the lower gastrointestinal tract.

The Solar Compact System’s portable and cost-effective design is tailored for offices. It streamlines the process of conducting pharyngeal, esophageal, and anorectal motility investigations, incorporating biofeedback mechanisms and accommodating air-charged and solid-state catheters. With its diverse diagnostic capabilities, the Solar Compact System is a standout choice for its adaptability and efficacy in diagnosing defecatory disorders.

“The Solar Compact System and Solar Catheter were designed for portability and with single-use HRAM catheters that do not need to be sterilized like their solid-state reusable predecessors,” said Rhett Klein, Vice President and General Manager of Laborie’s Gastroenterology Business Unit. “At Laborie, our primary objective is to provide solutions that add clinical value to practices, improve patient outcomes, and enhance the patient experience.”

In addition to being equipped with powerful features tailored to enhance diagnostic efficiency and accuracy, the Laborie software also adheres to the International Anorectal Physiology Working Group (IAPWG) protocol, ensuring consistency with guidelines. Automatic analysis based on the London Classification streamlines the interpretation process, and the QuickView Analysis software offers intuitive functionality for precise and efficient data interpretation.

The HL7 and network availability ensures seamless connectivity, facilitating effortless data sharing and integration into existing systems. Moreover, the software offers customizable procedures and reports, allowing for tailored solutions to meet the specific needs of healthcare providers and their patients.

As per DelveInsight’s Balloon Catheters Market Report,” the global balloon catheters market was valued at USD 4.60 billion in 2023, growing at a CAGR of 8.78% during the forecast period from 2024 to 2030 to reach USD 7.62 billion by 2030. Factors such as the rising prevalence of lifestyle disorders such as hypertension and obesity which present themselves as major risk factors for the development of cardiovascular diseases as well as brain aneurysms, increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities, growing geriatric population base where age itself plays a major role in disease etiology, and technical innovation in product development such as manufacture of drug-coated balloon catheters aimed at drug delivery at the site of action among other factors are expected to drive the balloon catheters market.

Carestream Launched Image Suite MR 10 Software to Enhance Imaging Experience for CR and DR Imaging Systems

On May 20, 2024, Carestream launched its Image Suite MR 10 Software to help deliver a boost to productivity and efficiency while enabling a more user-friendly imaging experience for radiographers.

Carestream’s Image Suite Software helps optimize imaging performance for both Computed Radiography (CR) and Digital Radiography (DR) imaging systems, with a user-friendly interface, specialized measurement tools, and an optional Mini-PACS module.

“Our Image Suite Software is purpose-built to deliver the benefits radiographers need to focus on what matters most—their patients,” said Praveen Rajgopal, Global Product Marketing Manager. “Image Suite MR 10 helps push the envelope further for even more focus on patient care.”

The latest enhancements aim to elevate productivity and efficiency within the realm of medical imaging. Among these advancements is the introduction of Focus HD Detector Support, designed to augment efficiency and maximize the utility of DR Retrofit Imaging Systems. Additionally, the implementation of DR TQT empowers radiographers to conduct Total Quality Testing, ensuring thorough quality control and optimal performance of DR Detectors. Another notable improvement comes in the form of Classic CR Mammography Enhancements, which offer heightened control and flexibility while enhancing image quality for increased diagnostic confidence in mammography procedures.

Furthermore, the inclusion of Optional DR LLI Auto-Stitching streamlines workflow by automatically stitching images when applicable, effectively saving time and reducing manual effort. These collective innovations signify a significant leap forward in enhancing productivity and efficiency across various facets of medical imaging, ultimately contributing to more streamlined and effective patient care.

“These new features help take our Image Suite Software to the next level to deliver a radically improved imaging experience,” said Mr. Rajgopal. “With these advancements, we’re helping make the imaging process not only easier and less stressful for radiographers but more impactful for their patients as well.”

According to DelveInsight’s Diagnostic Imaging Equipment Market Report, the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2020, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion. The demand for Diagnostic Imaging Equipment is primarily attributed to the rising technological advancement, growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, growing demand for effective & efficient imaging technologies for diagnosis, and increasing geriatric population.

Implicity’s Heart Failure Algorithm Gained FDA 510(k) Approval 

On May 20, 2024, Implicity announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new groundbreaking algorithm, SignalHF1, used in its remote monitoring solution.

Implicity was the first private company authorized to access the Health Data Hub. Based on the Health Data Hub complete medico-administrative database and comprehensive datasets from Implicity’s AI-based remote monitoring platform, the Implicity team trained and validated a machine learning algorithm that assesses the risk of future heart failure events, enabling physicians to intervene before a patient requires hospitalization.

“Heart failure remains a significant healthcare challenge, contributing to approximately one million hospitalizations each year. Preventing even a portion of these would be a game-changer in cardiac care,” said Dr. Arnaud Rosier, Implicity’s CEO and cardiologist. “SignalHF is an innovative and effective tool that physicians can use to assess risk of hospitalization due to heart failure earlier, enabling interventions that can lead to better outcomes and reduce hospital admissions.”

SignalHF is unique in that the manufacturer-agnostic solution can be used to analyze data collected from a variety of Cardiac Implantable Electronic Devices (CIED), including implantable cardiac defibrillators (ICD), pacemakers (PM) and cardiac resynchronization therapy devices (CRT-P, CRT-D) from Biotronik, Boston Scientific and Medtronic. SignalHF is the first pacemaker-compatible heart failure algorithm on the market. The algorithm can accurately identify trends indicating whether a patient’s condition is worsening. Care teams receive an automatic alert when the patient’s risk score crosses an established threshold, indicating an individual is at high risk of experiencing heart failure and being hospitalized shortly.

“Comprehensive heart failure management includes treatment, prevention, and personalization. Implicity’s solution is part of this approach. Our alerts are generated in context with a patient’s medical profile to help personalize care management plans. Furthermore, 75% of the alerts preceding a patient hospitalization are sent at least 14 days in advance – offering a two-week window to adjust medications or take proactive measures,” said Issam Ibnouhsein, Head of Data at Implicity.

According to DelveInsight’s Congestive Heart Failure Treatment Devices Market Report, the global congestive heart failure (CHF) treatment devices market was valued at USD 17.41 billion in 2023, growing at a CAGR of 8.26% during the forecast period from 2024 to 2030 to reach USD 27.96 billion by 2030. The Congestive Heart Failure (CHF) Treatment Devices market is witnessing positive growth owing to the rising incidence of Cardiovascular Diseases (CVDs), a surge in the research and development activities in product development, and increasing incidences of the aging population who are susceptible to these diseases. Moreover, sedentary lifestyle and the extreme benefits of these devices in heart failure cases during the COVID-19 pandemic and the growing popularity of minimally invasive interventions have further pushed the demand for these devices, thereby contributing to the growth of Congestive Heart Failure (CHF) Treatment Devices market during the forecast period from 2024 to 2030.

AngioDynamics Announced CE Mark Approval in Europe for AlphaVac F1885 System

On May 21, 2024, AngioDynamics, Inc. announced European CE Mark approval for the AlphaVac F1885 System for the non-surgical removal of thrombi or emboli from the pulmonary arteries and the treatment of pulmonary embolism (PE).

“The CE Mark represents a major step forward in enhancing patient care and safety for endovascular therapies in the EU, a market with a higher prevalence of PE when compared to the United States,” said Laura Piccinini, AngioDynamics Senior Vice President/General Manager, Endovascular Therapies and International. “This designation allows us to broaden our reach and provide innovative solutions to more healthcare professionals treating patients diagnosed with PE – on an increasingly global scale.”

Each year, approximately 435,000 pulmonary embolism (PE) incidents are estimated to take place across the six most populous European Union (EU) nations. In comparison to the United States, European emergency department admissions exhibit a greater prevalence of PE, with European patients presenting higher acuity levels and experiencing more adverse outcomes.

The CE Mark for the AlphaVac F1885 System expands treatment options for healthcare professionals in the EU by offering a tool that helps reduce thrombus burden and improve right ventricular function in patients with PE.

Moreover, in December 2023, AngioDynamics announced the completion of patient enrollment in its United States-based Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study, a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites to assess the AlphaVac F1885 System for the treatment of PE.

The APEX-AV trial showed a mean decrease in the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (significantly greater than the pre-defined performance goal of 0.12 (p < 0.001)) and a Major Adverse Event (MAE) rate of 4.1% (significantly lower than the pre-defined performance goal of 25% (p < 0.001)). The study also showed a 35.5% mean reduction in clot burden from baseline to 48 hours post-procedure3 and a mean procedure time of 37.2 minutes.

The AlphaVac F1885 System is an emergent first-line device that is currently CE-marked for the non-surgical removal of thromboemboli from the pulmonary arteries and the treatment of PE. The System includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator, and a waste bag assembly. The APEX-AV Study was designed to provide safety and efficacy data specific to PE.

According to DelveInsight’s Minimally Invasive Surgical (MIS) Devices Market Report, the global MIS devices market was valued at USD 28,873.25 million in 2023, growing at a CAGR of 7.38% during the forecast period from 2024 to 2030, to reach USD 42,499 million by 2030. The MIS devices market is witnessing positive market growth owing to factors such as the rising prevalence of various cancers such as lung cancer which accounted for the highest number of cancer-related deaths and highest cancer incidence in 2023, and other indications such as cardiovascular diseases, and neurodegenerative diseases among others. Furthermore, the presence of factors such as growth in the aging population wherein age plays a key role in the development of various indications is another factor driving the growth of the MIS devices market. Moreover, the technological advancements in product development such as the development of surgical robots are further driving the MIS devices market as new products are gaining regulatory approvals that are entering the market.

HeartBeam’s Artificial Intelligence Algorithm Combined with Vectorcardiography (VCG) Outperforms Expert Cardiologists in Detecting Arrhythmias

On May 20, 2024, HeartBeam, Inc. announced new study data demonstrating that HeartBeam AI combined with vector cardiography (VCG) outperformed an expert panel of heart rhythm cardiologists in detecting atrial flutter. 

HeartBeam AI is the company’s deep learning (a form of AI) algorithm for detecting abnormalities in the timing or pattern of heartbeats. The data was presented by Joshua M. Lampert, MD, Cardiac Electrophysiologist, Assistant Professor of Medicine, and Medical Director of Machine Learning for Mount Sinai Fuster Heart Hospital at the Icahn School of Medicine at Mount Sinai, during the Heart Rhythm Society annual meeting in Boston.

In the study, HeartBeam AI was applied to a set of 173 VCGs, single-lead ECGs, and 12-lead ECGs to identify atrial flutter. The same set of single-lead ECGs and 12-lead ECGs was reviewed by a panel of three electrophysiologists (EP panel) for atrial flutter, a common arrhythmia that significantly increases a patient’s risk for stroke. 

Key findings from the analysis show that HeartBeam AI combined with VCG:

  • Outperformed an expert panel reviewing single-lead ECGs, with a statistically significant 40% improvement in the detection of atrial flutter cases (sensitivity: 97.3% for HeartBeam AI+VCG vs. 69.4% for EP panel).
  • Demonstrated a statistically significant 6% improvement in the detection of atrial flutter cases compared to an expert panel reviewing 12-lead ECGs (sensitivity: 97.3% for HeartBeam AI+VCG vs. 91.1% for EP panel).
  • Delivered zero variability in the detection of atrial flutter compared to the EP panel.

Dr. Lampert commented, “The modern vectorcardiogram is nearly 100 years old, and yet we are cautiously breathing new life into it with the advent of novel acquisition technologies and deep learning algorithms. This study demonstrates that a deep learning algorithm applied to a transformed VCG performs comparably as well when applied to the gold-standard 12-lead ECG. The AI algorithm overall outperformed a panel of electrophysiologists in distinguishing atrial flutter from sinus rhythm with perfect agreement between multiple model predictions compared to significant interobserver variability amongst electrophysiologists, a finding particularly notable on single lead ECG analysis.”

HeartBeam’s core vector electrocardiography (3D VECG) technology captures the heart’s signals in three projections (X, Y, Z), similar to VCG, and synthesizes a 12-lead ECG. The Company’s first planned application of the 3D VECG platform technology is HeartBeam AIMIGo™, a credit card-sized device for patient use at home or anywhere, which is currently under review with the FDA.

By leveraging AI to analyze the data-rich signals, HeartBeam believes it will be able to improve diagnostic accuracy and unlock a more personalized approach to cardiac care for patients. As a patient uses AIMIGO over time, there will be a series of ECG readings. HeartBeam aims to leverage AI to analyze the data to provide a longitudinal view of the patient’s cardiac status and move beyond 12-lead ECGs, which typically only provide a snapshot in time.

“The data is incredibly encouraging, showcasing the potential of our artificial intelligence program to improve diagnostic accuracy when a patient is outside of a medical facility,” said Branislav Vajdic, PhD, CEO and Founder of HeartBeam. “We’ll continue to build upon this strong foundation as we advance our AI program to revolutionize cardiac care management in the future.”

According to DelveInsight’s Cardiac Arrhythmia Monitoring Devices Market Report”, the global cardiac arrhythmia monitoring devices market will grow at a CAGR of 6.33% during the forecast period from 2024 to 2030. The increase in demand for Cardiac Arrhythmia Monitoring Devices is primarily attributed to the rising prevalence of cardiovascular diseases, rising expenditure on cardiac health globally, rising adoption of mobile and telemetry cardiac monitors, rising prevalence of cardiac arrhythmias, rising technological advancements in monitoring devices, among others are also expected to bolster the demand for these services during the forecast period (2024-2030).

Onward ARC-EX Nerve Stim Hit Pivotal Trial Endpoints Restoring Limb Function

On May 21, 2024, Onward Medical announced positive data supporting the use of its ARC-EX nerve stimulation therapy for restoring upper limb movement.

The Netherlands-based company published findings from the Up-LIFT pivotal trial in Nature Medicine. Up-LIFT achieved all primary safety and effectiveness endpoints. Additionally, ARC-EX showed significant improvements in upper limb strength, function, and sensation among those with chronic tetraplegia due to cervical spinal cord injury (SCI).

Onward ARC-EX therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. It enables increased strength, movement, and function in the upper limbs after SCI.

The company submitted ARC-EX to the FDA for approval last month. It also plans to follow with a European submission.

If approved, the company said that ARC-EX would become the first ever SCS therapy that restores hand and arm function after SCI. It would also become the first commercial product for Onward. The company also has its investigational ARC-IM system for improved blood pressure regulation after spinal cord injury and the ARC-BCI system that won FDA breakthrough device designation in February. 

At the end of Up-LIFT, 72% of trial participants were considered responders to non-invasive ARC-EX therapy. Investigators based this designation on a conservative definition requiring responders to meet improvement criteria in both strength and functional domains vs. standard of care rehabilitation alone.

The number of responders increased to 90% when the definition included participants with improvements in at least one strength or functional outcome.

Participants also reported reduced spasm frequency, improved sleep, and improved upper body sensation. That included the sense of touch. Onward said 87% of participants reported that ARC-EX therapy delivered improvements in overall quality of life. Self-care, a key component of independence after SCI, also improved significantly.

“Improvement in arm and hand function is among the highest priorities for people with tetraplegia who have endured far too long without effective therapies for functional recovery,” said Dave Marver, CEO, Onward Medical. “The findings published in Nature Medicine provide critical and compelling evidence that ARC-EX has the potential to restore independence in daily activities and improve quality of life. We are laser-focused on our commitment to bring this first-of-its-kind technology to the SCI community as soon as possible.”

According to DelveInsight’s Nerve Monitoring System Market Report”, the global nerve monitoring systems market was valued at USD 1.28 billion in 2023, growing at a CAGR of 4.17% during the forecast period from 2024 to 2030, to reach USD 1.63 billion by 2030. The demand for nerve monitoring systems is primarily motivated by the rise in nerve-related disorder patient population, easy availability of medical reimbursement for these procedures, increasing demand for advanced products, and the strong presence of device manufacturers in the market.