HEALTH TECHNOLOGY
L2Mtech | February 17, 2021
CE Mark Approval for LimusTrack™, Sirolimus Eluting Coronary Stent System for Cardiovascular Applications.
CE Mark Approval for LomiFlow™, Paclitaxel Drug Eluting Balloon for Cardiovascular Applications
CE Mark Approval for PearlFlow™, Paclitaxel Drug Elutin Balloon for Endovascular Applications
CE Mark Approval for PearlFlow NS™, Self Expandable Nitinol Stent System for Endovascular Applications
CE Mark Approval for FlexiTrack 018™, Peripheral Balloon Catheter for Endovascular Applications
CE Mark Approval for FlexiTrack 035™, Peripheral Balloon Catheter for Endovascular Applications
Bonn, Germany – L2Mtech GmbH has announced the award of its first CE Mark approval on Six (6) products:
LimusTrack™ : Sirolimus Coated Cobalt Chromium Stent with biodegradable polymer for the treatment of coronary artery disease, de novo lesions, restenosis lesions.
LomiFlow™ : Paclitaxel Coated balloon catheter for the treatment of coronary artery disease, small vessels, dilatation of de novo lesions, in-stent restenosis (ISR) cases.
PearlFlow™ : Paclitaxel Coated balloon catheter for the treatment of peripheral arterial disease, PTA, dilatation of stenotic segments or lesions in peripheral arteries.
PearlFlow NS™ : Self-Expanding Nitinol Stent System for the treatment of peripheral arterial disease, de novo lesions, lesions in femoropopliteal arteries.
FlexiTrack 018™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in femoral, popliteal, tibial arteries.
FlexiTrack 035™ : Peripheral Balloon Dilatation catheter for the treatment of peripheral arterial disease, dilatation of lesions in the SFA, femoral arteries.
L2Mtech GmbH Founder and CEO Lalit Mamtani said ‘‘We are very excited to have been awarded our first CE Mark on six products, CE Mark approval represents a key milestone for L2Mtech GmbH and is a testament to the efficacy and safety of our innovative technology products for Cardiovascular and Endovascular applications.“
We now prepare to commercially launch the products in all markets where the CE Mark is recognized. With introduction of our innovative technology products in markets, we will be able to expand treatment options for the benefit of many millions of patients with coronary and peripheral artery disease around the world.
About L2Mtech
Founded in 2017, L2Mtech GmbH is a privately-owned multinational medical device company headquartered at Bonn, Germany. L2Mtech specializes in design, development, manufacture and commercialization of medical devices that are used by healthcare establishments globally. L2MTech will provide interventional physicians with innovative vascular devices including Drug Eluting Balloon manufactured in Europe.Our Core mission is to build a product portfolio focused on minimally invasive treatment for patients with cardiovascular,endovascular and vascular artery disease. For further information, please visit : L2MTech.de
Media Contact:
L2Mtech GmbH
admin@L2Mtech.de
+49 228 94730761
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AI
Aidoc | January 25, 2022
Aidoc,the leading provider of enterprise-grade AI solutions for medical imaging, announces a partnership with Novant Health, a health network of over 1,800 physicians with 15 medical centers across three states. By incorporating Aidoc's AI platform, which includes seven FDA-cleared solutions for triage and notification of patients with acute medical conditions, Novant Health is taking proactive steps to improve patient outcomes and reduce emergency department (ED) length of stay amid resource constraints inflicted by the Omicron variant.
With a dedication to digital transformation for improving workflow efficiencies and patient outcomes, Novant Health is one of the first health networks inNorth Carolinato adopt Aidoc's AI platform. Novant Health has integrated multiple technologies and has been recognized by the College of Healthcare Information Management Executives'(CHIME) "Digital Health Most Wired" program five years in a row for effectively applying "core and advanced technologies into their clinical and business programs to improve health and care in their communities."
"When diagnosing and treating critical pathologies like pulmonary emboli and hemorrhagic strokes, every second counts," said Dr. Eric Eskioglu, Executive Vice President Chief Medical and Scientific Officer, Novant Health. "We are thrilled to partner with Aidoc to bring yet another leading-edge AI-technology to Novant Health. For years, we've been committed to harnessing innovative technologies to improve patient safety and outcomes through the Novant Health Institute of Innovation and Artificial Intelligence. With Aidoc's technology, our physicians will be able to more quickly identify and prioritize these patients and provide rapid life-saving treatments."
From Aidoc's AI platform, Novant Health will be utilizing the intracranial hemorrhage (brain bleeds), pulmonary embolism (lung blood clots), incidental pulmonary embolism, c-spine fracture, and abdominal free air AI solutions. In one example, a studyconducted by the Yale New-Haven Health System found that Aidoc's intracranial hemorrhage AI solution was able to reduce ED length of stay by approximately one hour.
"With rapidly rising numbers of people infected with the highly contagious Omicron variant, we can see the hard impact on hospital emergency room capacities and resources across the U.S. We're proud to partner with a leading, innovative hospital network like Novant Health, which serves a large portion of the population in the three states its facilities are located in. Together, through our AI solutions and their state-of-the-art facilities, we will enable radiologists and related hospital providers to expedite care for tens of thousands of patients, contributing toward a mitigation of the current emergency room situations and setting an example for integrating innovation during turbulent and non-turbulent periods."
Elad Walach, CEO and co-founder of Aidoc
About Aidoc
Aidoc delivers the most comprehensive and widely-used portfolio of AI solutions, supporting providers by flagging patients with suspected acute conditions in real-time, expediting patient treatment and improving quality of care. Aidoc's healthcare AI platform is currently used by thousands of physicians in hospitals and radiology groups worldwide and across multiple care coordination service lines, having analyzed over 10.3 million scans in the past year.
About Novant Health
Novant Health is an integrated network of physician clinics, outpatient facilities and hospitals that delivers a seamless and convenient healthcare experience to communities inNorth Carolina,South Carolina, andGeorgia. The Novant Health network consists of more than 1,800 physicians and over 35,000 employees who provide care at nearly 800 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics. In 2021, Novant Health was the highest-ranking healthcare system inNorth Carolinato be included onForbes'Best Employers for Diversity list. Diversity MBA Magazineranked Novant Health first in the nation on its 2021 list of "Best Places for Women & Diverse Managers to Work." In 2020, Novant Health provided more than$1.02 billionin community benefit, including financial assistance and services.
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MEDICAL DEVICES
BD | December 22, 2021
BD (Becton, Dickinson and Company), a leading global medical technology company, today announced it has completed the acquisition of privately held Scanwell Health Inc., a leader in smartphone-enabled at-home medical tests.BD collaborated with Scanwell to develop the app used with the recently launched BD Veritor™ At-Home COVID-19 Test, the first at-home COVID-19 test that uniquely uses a smartphone camera and app to capture and interpret results, eliminating the human subjectivity in other visually read at-home antigen tests. Scanwell will become the foundational digital platform upon which BD plans to develop at-home diagnostic tests for a range of infectious diseases including COVID-19/influenza A+B, group A strep and additional menu for detecting infections and managing chronic disease.
"The COVID-19 pandemic has accelerated the shift to new care settings, and BD is ready to deliver a smart, connected at-home diagnostic ecosystem to support traditional and telehealth providers and consumers. This acquisition will enable us to expand and scale our digital capabilities in-house to speed time to market for transformative at-home solutions now and in the future."
Dave Hickey, president of Life Sciences for BD
The Scanwell app is a key differentiator in the market for at-home COVID-19 testing. To date, no other company uses the phone's camera to capture the image of the test that is then analyzed and interpreted by the app. Other COVID-19 home tests use smartphones as part of their process, but BD Veritor™ At-Home COVID-19 Test is the first and only test to use the smartphone as the analyzer to digitally interpret the test results and provide a definitive POSITIVE or NEGATIVE digital display of testing results. The app also has the capabilities to securely store and report test results to organizations, including businesses, public health authorities and schools. The results of tests are stored in the app and can be referenced and displayed at any time by simply logging into the app.
Terms of the transaction were not disclosed. The transaction is expected to be immaterial to BD's fiscal 2022 financial results. Scanwell financial results will be reported under the Integrated Diagnostic Solutions business within the Life Sciences segment.
About the BD Veritor™ At-Home COVID-19 Test
The BD Veritor™ At-Home COVID-19 Test has not been FDA cleared or approved; but has been authorized by FDA under Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
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MEDICAL DEVICES
Medtronic | January 11, 2022
Medtronic plc, a global leader in healthcare technology,today announced it has received approval fromJapan'sMinistry of Health, Labor and Welfare for the sale and reimbursement of the Micra™ AV Transcatheter Pacing System (TPS), and the company will launch the product this month.
This approval expands the number of patients inJapan– one of the largest markets in the world – who are eligible to receive the Micra TPS, the world's smallest pacemaker. The Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. The Micra TPS is the first-ever leadless pacemaker; its first version (the Micra VR) was approved inJapanin 2017 for patients who only require single-chamber pacing.
"Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring," explainedKyoko Soejima, professor of cardiovascular internal medicine at Kyorin University Hospital and a member of the Micra TPS Global Clinical Trial steering committee. "The first Micra system transformed the concept of pacemakers by eliminating surgical pockets and leads, and Micra AV promises to deliver the benefits of leadless pacing to a larger number of patients because ventricular pacing can be performed synchronously with the atrium."
Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called "leads." Identical in size and shape to the original Micra TPS, Micra AV has several additional algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.
The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra's internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony.
"Since introducing the first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to pioneer pacing innovations for physicians and their patients."
Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic
About the Micra Transcatheter Pacing Systems (TPS)
The Micra TPS received CE Mark inApril 2015and U.S. FDA approval in 2016. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers yet delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, the device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device.
Unlike traditional pacemakers, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are reduced, and there is no visible sign of the device.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered inDublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
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