Aidoc Expands AI Service to X-ray, Receiving FDA 510(k) Clearance for Pneumothorax
On March 30, 2022, Aidoc, the leading developer of healthcare AI solutions, announced that its triage and notification of pneumothorax on X-ray exams has gained FDA 510(k) approval. Aidoc’s other seven FDA-cleared clinical AI products are already in use throughout U.S. health systems, flagging and communicating probable pathologies in CT scans — and have extended to the high-volume X-ray modality.
Aidoc’s recent FDA-cleared solution analyses X-ray pictures and operates on all X-ray equipment, including portable ones. It automatically identifies positive pneumothorax situations, making it easier for doctors to examine X-rays quickly.
It’s critical to be able to recognize a pneumothorax promptly since it can swiftly progress and lead to respiratory or cardiac collapse. Due to the large amounts of imaging that radiologists must evaluate regularly, this is easier said than done. This problem is addressed by Aidoc’s extremely accurate AI pneumothorax algorithm, which analyses X-rays, and flags, and notifies clinicians of probable discoveries.
Elad Walach, CEO of Aidoc, said, “We’re very excited about this important milestone. This FDA clearance further validates the breadth of our AI platform, going beyond specific AI algorithms to act as a healthcare AI hub for the enterprise’s cross-specialty needs. This includes ER, ICU, outpatient centers, inpatient admissions, and the coordination of care and communication among providers. By bringing radiologists and proceduralists to the same AI platform, we enable enhanced collaboration across departments and systems to deliver patients with the right treatment at the right time.”
The AI platform used by Aidoc handles large amounts of scans and pictures without interfering with the physician’s workflow. Existing Aidoc partners that add the pneumothorax solution to their portfolio won’t need to invest in extra integration, infrastructure, or maintenance.
According to DelveInsight’s “X-Ray Devices Market” report, the demand for X-Ray devices is primarily being boosted by the rising incidence observed in different types of cancer cases and rising prevalence observed in patients affected with cardiovascular diseases, rise in the number of orthopedic disorders such as injuries and diseases affecting the musculoskeletal system in humans, and technological advancements in the X-Ray devices arena which are expected to increase in the product demand thereby contributing in the growth of the X-Ray devices market during the forecast period from 2022-2027.
Cook Medical Receives FDA Breakthrough Device Designation for Zenith® Thoraco+ Endovascular System
On March 31, 2022, The US Food and Drug Administration has designated Cook Medical’s Zenith® Thoraco+ Endovascular System (Thoraco+) as a Breakthrough Device (FDA). This designation is awarded to products that have the potential to provide more effective treatment or diagnostics for illnesses or disorders that are life-threatening or permanently disabling.
While the product is not yet commercially accessible, the designation provides priority review and interactive and timely communication with the FDA during the clinical trial and pre-market review phases, assisting in the faster delivery of lifesaving technologies to patients.
Cook Medical’s Thoraco+ is the company’s second device to obtain a Breakthrough Device Designation in 2022.
Mark Breedlove, senior vice president of Cook Medical’s Vascular division, said, “We are excited to receive an FDA Breakthrough Device Designation for the Thoraco+. This will be a great addition to our portfolio of aortic products so we can offer treatments to a wider variety of patients.”
The Thoraco+ is a next-generation endovascular graft for the treatment of thoracoabdominal aortic aneurysms, built on the foundation of the established Zenith platform. The system is intended for the endovascular treatment of thoracoabdominal aortic aneurysms in patients (Crawford classification I-IV).
The Thoraco+ is a commercially available device with four side branches for the celiac, superior mesenteric, left renal, and right renal arteries. The Thoraco+ will be offered in a variety of diameters and lengths to meet a wide range of patient anatomy.
According to DelveInsight’s “Vascular Graft Devices Market” report, the factors such as the rising prevalence of lifestyle disorders like hypertension and diabetes present themselves as major risk factors for the development of cardiovascular diseases such as aortic aneurysms and peripheral artery disease, growing geriatric population base where age itself plays a major role in disease etiology, and technical innovation in product development such as the manufacture of coated vascular graft devices with improved features among other factors are expected to drive the vascular graft devices market.
Smith+Nephew Announces New Study Showing GRAFIX™ Membrane Cut the Rate of Diabetic Foot Ulcer Recurrence in Half Compared to Leading Competitors
On March 31, 2022, The global medical technology company Smith+Nephew announced the publication of a peer-reviewed study in the Advances in Wound Care Journal that shows GRAFIX Cryopreserved Placental Membrane cut diabetic foot ulcer (DFU) recurrence rates in half when compared to leading cellular and tissue-based product (CTP) competitors.
Over 1.3 million Medicare patients with lower limb chronic ulcers were assessed, and 7,849 claims for patients treated in an outpatient setting between 2013 and 2017 who presented with a DFU and got a CTP were analyzed. It compared ulcer recurrence rates, patient mortality, and other outcomes with GRAFIX Membrane vs. Cellular CTPs and vs. Acellular CTPs at 30-, 90-, 180-, and 365 days. Apligraf® (Organogenesis, a Cellular CTP) and EpiFix® are two of the study’s major competitors (MiMedx, a devitalized Acellular CTP).
For patients presenting with a DFU, the study found a statistically significant reduction in ulcer recurrence and/or new ulcer formation when GRAFIX was compared to either Cellular or Acellular CTP groups at all periods, ranging from 36.7% reduction at 30-days compared to Cellular CTPs to 58.5% reduction at 365-days compared to Acellular CTPs (p 0.001). At each time point, mortality rates were examined, and the variations found were positive. To establish proper comparisons, the cohorts were risk-adjusted.
Dr. Charles Ananian, DPM commented, “This new study cements what I have seen in my practice with the GRAFIX Membrane products. In conjunction with standard of care, GRAFIX has led to a higher percentage of closed wounds, faster wound closure, and less ulcer recurrence than many competitors.5,6 In indicated wounds, GRAFIX has proven itself as a high-performing therapy for difficult-to-treat wounds.”
Simon Fraser, Smith+Nephew President of Global Advanced Wound Management, said “Smith+Nephew is committed to helping patients with chronic wounds live a Life Unlimited. Backed by evidence, GRAFIX delivers on this promise by helping patients with chronic wounds as an advanced therapy shown to be clinically superior to standard of care and leading competitors. Because of the strong body of clinical evidence for GRAFIX, Medicare and all of the top 50 commercial payers now cover GRAFIX for DFU, including recent positive coverage by the largest payer in the US. ”
According to DelveInsight’s “Diabetic Wounds Market“ report, the Diabetic Wounds market are witnessing positive growth owing to the rising prevalence of diabetes, increase in diabetic foot ulcers among the population, the launch of novel active therapies, a surge in the number of amputations due to diabetic foot ulcers, thereby contributing to the growth of the Diabetic Wounds market during the forecast period from 2022-2027.
REDUCE LAP-HF II Analyses Show 50% of Study Patients Demonstrated Significant Clinical Benefit from the Corvia® Atrial Shunt
On April 01, 2022, Corvia Medical, Inc., a firm devoted to improving the treatment of heart failure (HF), has released results from its worldwide, phase III REDUCE LAP-HF II randomized study, which included heart failure patients with preserved (HFpEF) or slightly decreased (HFmrEF) ejection fraction. Treatment with the Corvia® Atrial Shunt resulted in a 45% decrease in HF episodes and a 55% higher improvement in quality of life compared to sham control in a large responder group, comprising 50% of study participants. Furthermore, these findings add to our understanding of the significance of exercise in properly identifying which patients may benefit from this unique therapy. The analyses were published online in Circulation.
The Corvia Atrial Shunt is intended to lower excessive left atrial pressure (LAP), which is the major cause of Heart Failure symptoms in individuals with HFpEF. The shunt is implanted between the left and right atria by catheter, creating a route that allows blood to flow from the high-pressure left atrial to the lower-pressure right atrium, lowering HF symptoms and events while also enhancing the quality of life.
Sanjiv Shah, MD, Professor of Medicine, Director of Research for the Bluhm Cardiovascular Institute, Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, and co-principal investigator of the REDUCE LAP-HF II trial, said, “We are extremely encouraged by these analyses from the REDUCE LAP-HF II trial. Not only have we identified a large responder group comprising two-thirds of people with HFpEF, or approximately 2 million people in the US alone, but we have also learned how to identify potential patients who are most likely to derive significant benefit.”
Barry Borlaug, MD, Professor of Medicine, Director of Circulatory Failure Research at Mayo Clinic, and lead author of the publication commented, “Exercise hemodynamic evaluation appears to be a key factor in predicting which patients will do well with atrial shunt therapy. Patients whose pulmonary blood vessels, or vessels in the lungs, can accommodate an increase in blood flow during exercise appear to derive significant benefit from the shunt, compared to those whose blood vessels can’t accommodate the additional flow. While I have long been an advocate for hemodynamic testing in heart failure, the data from this study reinforce the importance of exercise phenotyping and will change how we evaluate heart failure patients and personalize their care.”
626 participants were randomized in the REDUCE LAP-HF II trial, which took place at 89 locations across the United States, Canada, Europe, Australia, and Japan. The most important variables impacting how patients responded to atrial shunting were exercise pulmonary vascular resistance (PVR), a measure of the degree of pulmonary vascular disease, and the existence of a pacemaker, according to a comprehensive, independent statistical study. Patients without a pacemaker and with normal exercise PVR accounted for half of the whole research group and received considerable clinical benefit:
- 45% reduction in HF events compared to sham control (12 vs. 22 events per 100 patient-years, p=0.007)
- 55% greater improvement (+5.5 points) in health status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), with 40% more shunt patients reporting a very large improvement (≥20 points) in quality of life
- 50% greater improvement in New York Heart Association (NYHA) HF class, indicating fewer HF symptoms
Prof. David Kaye, MD, Ph.D., Director of the Department of Cardiology at The Alfred Hospital, Head of Heart Failure Research at the Baker Institute in Melbourne, Australia, and an investigator in the study, commented, “HFpEF has a complex pathophysiology and remains a significant therapeutic challenge. While novel drugs are now available, limitations remain, and additional therapies are required to treat this heterogenous population. We now know the importance of exercise hemodynamic phenotyping prior to determining a therapeutic strategy for HFpEF patients and these learnings should be applied today in both the commercial and clinical trial settings. Assuming additional studies confirm the responder population findings, this therapy has enormous potential to improve the lives of millions of heart failure patients.”
REDUCE LAP-HF II represents the largest randomized controlled trial of device-based therapy for HFpEF patients and is the only study of an implantable therapeutic device to show clinical benefit in this population.
Bioventus Exercises Call Option to Acquire CartiHeal
On April 04, 2022, Bioventus Inc., a global leader in active healing innovations, announced that it has exercised its call option to purchase CartiHeal Ltd. for $315 million, excluding the ownership interest already held by Bioventus, plus an additional $135 million contingent on the achievement of $100 million in trailing twelve-month sales. Bioventus intends to fund the purchase with extra debt. The Company’s decision to execute this option comes after the FDA granted CartiHeal’s Agili-CTM implant premarket approval (PMA) on March 29, 2022.
In 2020, the FDA granted Agili-C Breakthrough Device Designation for the treatment of International Cartilage Repair Society (ICRS) grade III or above the knee–joint surface lesions with a total treated area of 1-7 cm2 in patients without severe osteoarthritis (KOOS grade 0-3). The Agili-C implant is projected to be a cost-effective treatment for cartilage regeneration and bone remodeling in patients with knee joint surface lesions, allowing them to avoid complete knee replacement.
Ken Reali, CEO of Bioventus, said, “CartiHeal represents an important breakthrough for the treatment of osteoarthritis, and we are excited to bring this complementary product into our growing portfolio of medical devices. CartiHeal addresses an unmet need in joint preservation and cartilage regeneration for approximately 675,000 U.S. patients annually, representing an estimated $1.3 billion market opportunity for Bioventus. The CartiHeal team has done a tremendous job developing the implant, as evidenced by strong clinical data demonstrating clinical superiority over microfracture or debridement. We look forward to leveraging our strong existing commercial infrastructure to begin commercializing CartiHeal in the coming months.”
The acquisition is scheduled to occur in the second quarter, subject to normal closing circumstances, and Bioventus aims to launch CartiHeal in the United States in the third quarter of 2022 as a limited market release (LMR).
GE Healthcare, Imeka to Collaborate on Brain MRI Technology
On April 05, 2022, Imeka has established a partnership with GE Healthcare to promote the use of magnetic resonance imaging (MRI) for brain health.
Imeka’s non-invasive neuroimaging technology will be integrated into GE Healthcare’s BrainWave advanced diffusion processing package, allowing researchers and clinicians to examine diffusion MRI signals in the brain in more depth.
The BrainWave analysis and visualization tool for functional brain imaging data are offered by GE Healthcare in collaboration with Medical Numerics. The platform, according to a press release, allows for the processing, analysis, 3D rendering, and presentation of data from BOLD MRI and diffusion tractography images.
GE Healthcare GM of MR Applications Platform and Research Technologies Jason Polzin said in the release, “GE Healthcare remains at the forefront of precision health – driven by our commitment to provide clinicians the tools and information they need to deliver the best patient care possible. We are proud to collaborate with Imeka to offer medical practitioners advanced neuroimaging tools that make it easier, faster, and more efficient to make informed decisions and deliver personalized care for patients impacted by brain diseases.”
Researchers and clinicians will be able to swiftly get highly localized images of white matter using BrainWave and Imeka’s neuroimaging processing technology, providing insights into the effect of central nervous system (CNS) illnesses and disorders.
Imeka CEO Jean-René Bélanger said, “Imeka has experienced rapid momentum over the past several months, including customer and company growth and collaborations with industry innovators like GE Healthcare. Our Advanced Neuro Imaging Endpoints (ANIE) biomarker platform is helping scientists, researchers, and clinicians across pharma, life sciences, and healthcare organizations accelerate the search for and development of cures for brain diseases. We are excited to partner with GE Healthcare, a pioneer in medical imaging, to expand into additional markets and help clinicians improve patient outcomes.”
According to DelveInsight’s “Magnetic Resonance Imaging Devices Market” report, the Magnetic Resonance Imaging Devices market is witnessing positive growth owing to the factors such as the rising cases of severe chronic diseases like various cancers, cardiac abnormalities, and others, further rapid technological developmental activities, growing geriatric population, rising adoption owing to non-invasiveness, thereby contributing to the growth of the Magnetic Resonance Imaging Devices market during the forecast period from 2022-2027.