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.
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
+49 228 94730761
CareCloud, Inc | December 17, 2021
CareCloud, Inc., a leader in healthcare technology solutions for medical practices and health systems nationwide has released CareCloud Connector, a next-generation interface and data management engine, and the first product within its CareCloud Conductor suite. CareCloud Connector enables healthcare organizations with ready-to-use integrations that improve data management and deployment speed, while offering better interface visibility and control.
“We have been a leading healthcare IT innovator for almost two decades, providing solutions that improve financial, clinical, and patient outcomes, at scale, and a partner to a wide array of healthcare organizations. Today we are introducing our proprietary, turn-key integration technology platform to help healthcare ecosystem partners leverage the same tools we ourselves use to manage our business across hundreds of unique integrations spanning thousands of locations.”
Hadi Chaudhry, CEO and President, CareCloud
As the U.S. healthcare industry’s data exchange regulations continue to evolve and vendors prepare to comply with provisions in the Cures Act, legacy integration tools will hinder progress. CareCloud Connector provides a seamless, scalable, and centralized platform with APIs, allowing healthcare IT vendors, medical billing organizations, and digital health companies to overcome interoperability challenges and effectively manage data integration and transmission hurdles. Connector includes a library of industry-tested, ready-to-use integrations, interfaces, and customizable tools in a convenient SaaS offering.
"As one of the industry’s first true libraries of plug-and-play integration and customizable tools, CareCloud Connector transforms laborious developmental projects into simple and secure activations,” said Adeel Sarwar, Chief Technology Officer, CareCloud. “Connector makes data exchange and management simple and cost-effective for industry participants.”
"Healthcare organizations often struggle with managing hundreds of interface requests and data migration challenges. Couple this with the complexities of new regulatory requirements embedded in the Cures Act and you set the stage for a solution like Connector,” said David Botero, Director of Integrations, CareCloud. “Connector allows us to close interoperability gaps for industry participants. We are proud to be a leader in integration consolidation, empowering health organizations and service providers to comply with new interoperability requirements while saving money and resting easy, knowing that a leading publicly-traded healthcare IT vendor is taking care of the hard work for them."
CareCloud Connector is the first solution launching under CareCloud’s new technology suite, CareCloud Conductor. Conductor is a family of technologies designed to support interoperability, connectivity, and data transformation. CareCloud plans to unveil more products in the Conductor suite in 2022 with the launch of additional innovative solutions to support the growing prominence of health IT developers and investments in digital health.
CareCloudbrings disciplined innovation to the business of healthcare. Our suite of technology-enabled solutions helps clients increase financial and operational performance, streamline clinical workflows and improve the patient experience. More than 40,000 providers count on CareCloud to help them improve patient care while reducing administrative burdens and operating costs.
Purpose Investments | January 19, 2022
Purpose Investments Inc. (“Purpose Investments” or “Purpose”) is pleased to announce the launch of Purpose Healthcare Innovation Yield ETF (the “Fund”). The Fund has closed the offering of its initial units, and units of the Fund will begin trading today on the Toronto Stock Exchange under the ticker, HEAL.
The Fund is the first of its kind in Canada to provide actively managed exposure to innovation leaders in biotech and healthcare. The recent advances in healthcare are only the beginning of what Purpose believes to be a new multi-year cycle in biotech and healthcare breakthroughs that will provide investors with opportunity for attractive long-term returns. The Fund will invest in an all-cap portfolio in the high-growth areas of gene-editing, digital healthcare, medical testing, dental, health maintenance, hospitals, pharmacies, and animal health. The portfolio holdings are primed for long-term growth and armed with commercialization opportunities and a strong pipeline of products under development. The Fund will also employ a covered call options strategy to generate additional yield and will have a more attractive income profile than the broad healthcare index.
“The past two years have shown just how important it is to have innovative companies develop vaccines and push forward medical advancements. Between the pandemic and our aging population, the spotlight is on the industry to really grow and innovate. We launched this Fund to give Canadians an opportunity to get actively managed exposure to the healthcare companies that are changing the world with cutting-edge medical and technological advancements.”
Som Seif, founder and CEO of Purpose Investments
Purpose is the manager of the Fund and Next Edge Capital Corp. (“Next Edge Capital”) will act as the Fund’s sub-advisor. The Fund will be actively managed by Eden Rahimof Next Edge Capital, one of the world’s leading experts in healthcare investing. Mr. Rahim has an academic background in molecular genetics and extensive experience managing life-science and biotech portfolios. His active management, informed by his science background and industry experience, will position the Fund to capitalize on high-growth opportunities in the biotech and healthcare sectors.
“With this Fund, we will work to strategically identify key healthcare companies developing innovations that will profoundly improve people’s lives,” says Rahim. “Purpose Healthcare Innovation Yield ETF aims to provide investors with exposure to unique opportunities that may not be on their radar, so they can reap the full rewards of the high-growth areas in healthcare and science.”
“Eden is one of the leading global experts in healthcare investing, and someone who understands the math as well as the science backing the portfolio. We are excited to have such a seasoned portfolio manager help us maximize the growth opportunities in the space and provide investors with a strategy to generate attractive yield,” Seif concluded.
About Purpose Investments
Purpose Investments Inc. is an asset management company with approximately $14 billion in assets under management. Purpose has an unrelenting focus on client-centric innovation, and offers a range of outcome-focused products. Purpose Investments is led by well-known entrepreneur Som Seif and is a division of Purpose Financial, an independent technology-driven financial services company.
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.
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.