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
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.
PulsePoint | July 06, 2021
PulsePoint, a technology company revolutionizing health decision-making in real-time, today announced the next generation launch of its digital media buying platform, Life by PulsePoint™. Its enhanced AI and automation simplifies and supercharges the media planning, activation, and optimization processes. Designed for the self-serve programmatic trader, these updates promote efficiencies and surface predictive and in-flight campaign analytics for quick strategic decisioning to yield higher media return on investment.
Built upon PulsePoint's extensive data foundation, Genome™, that proactively uses microdata to capture attention when intent is signaled, Life is the leading healthcare end-to-end programmatic platform. Life's automated machine learning and AI allows marketers to quickly create highly-customized segments that classify populations in real-time, and deliver sequential messaging to drive customer actions in the moment and across the health journey.
This next generation of the Life platform includes:
• Advanced media planning innovations: Life offers an AI-powered forecasting tool used to run simulations to generate predictive performance metrics and intelligent audience insights. This makes it easier for marketers to preview budgets and ideate and adjust tactics to obtain their desired campaign outcomes, all before a single dollar is spent. Each forecast is powered by detailed supply and channel insights, like expected delivery, and campaign performance can be viewed by a variety of dimensions, including creative types, domains/apps, condition categories, healthcare professional specialties, geographies, among others.
• Better campaign management with advanced dashboard: An automated and real-time view of line item performance and pacing gives traders a deeper, more granular look into their campaigns, making it easier for them to optimize their spend based on flight delivery and anticipate new incremental opportunities. The dashboard not only surfaces key numbers, but it also includes dynamic performance charts to uncover real-time campaign insights.
• Turnkey PMP (private marketplaces) deal builder: Enhanced with turnkey end-to-end functionality, self-serve traders can now enable the deals that they negotiated directly with publishers and/or SSPs through Life's UI, decreasing the time it takes to launch PMPs.
"Life was built for the healthcare marketer to simplify and optimize marketing campaigns," said Andrew Stark, CRO of PulsePoint. "Our newest capabilities increase efficiencies through advanced forecasting and real-time performance optimization, enabling more control and enhanced campaign management."
Life by PulsePoint provides access to over 110 billion daily impressions across more than 2 million health pages, reaching 1.8M+ opted-in, verified healthcare professionals and over 90% of the online U.S. population. This release is just another step in PulsePoint's journey to deliver personalized messaging at each stage of the health journey using predictive insights built on real-time data.
The company was recently acquired by Internet Brands, a KKR portfolio company and owner of WebMD Health Corp. PulsePoint's teams will continue to operate as their own division from their existing hubs in New York, San Francisco, and London.
PulsePoint is a leading technology company that uses real-world data in real-time to optimize campaign performance and revolutionize health decision-making. Leveraging proprietary datasets and methodology, PulsePoint targets healthcare professionals and patients with an unprecedented level of accuracy—delivering unparalleled results to the clients we serve.
Jumio | March 21, 2022
Jumio, the leading provider of AI-powered end-to-end identity orchestration, eKYC and AML solutions, announced the launch of a Middle Eastern solutions portfolio and the appointment of Arshad Sheikh as its first sales leader for the Middle East, Turkey and North Africa region. This expansion builds on Jumio’s long-standing presence in the Middle East and its ongoing commitment to revolutionize banking for a growing number of customers in the region.
A recent forecast from the International Data Corporation states that digital transformation efforts in the Middle East, Turkey and Africa are set to top $58 billion in 2025, accounting for 40% of all information communication technology investments made that year. Additionally, McKinsey & Company found that 83% percent of payments practitioners operating in the Middle East and Africa believe digitizing the customer journey is the most important way to remain relevant in an evolving market.
With the Jumio KYX Platform, businesses from banking and financial services to government, healthcare and travel sectors can tap into services that accelerate digital transformation without sacrificing security and convenience. The KYX Platform leverages AI, biometrics, machine learning and certified liveness detection to help enterprises rapidly convert customers, stop fraudsters and maintain KYC and AML compliance. The key features and advantages of the platform extend an organization’s ability to monitor customer behavior from the initial point of account creation through the full lifecycle of customer interactions.
Based in Dubai, Sheikh will focus on expanding the company’s client base, growing relationships with existing clients and cultivating a sustainable partner network. Sheikh has more than 20 years of sales, business development and cybersecurity experience in the Middle East. Before joining Jumio, Sheikh worked at Carbon Black/VMWare, Barracuda Networks, Informatica, TrendMicro and Mindware.
“We are proud to continue growing in the METNA region in order to better serve the needs of our local customers and partners and to expand our global footprint so organizations can truly know their end users, no matter where in the world they are. Most industries in the region have been swept up in the need to digitally transform their businesses. Jumio’s end-to-end orchestration platform, aided by our extensive partner network, will massively simplify the journey and deliver successful business outcomes across all key industry sectors.”
Dean Hickman-Smith, Jumio chief revenue officer
For a live demonstration of the Jumio KYX Platform, visit Jumio at booth A34 during GISEC Global, which takes place this week in Dubai.
When identity matters, trust Jumio. Jumio’s mission is to make the internet a safer place by protecting the ecosystems of businesses through a unified, end-to-end identity verification, eKYC and AML platform. The Jumio KYX Platform offers a range of identity proofing and AML services to accurately establish, maintain and reassert trust from account opening to ongoing transaction monitoring.
Leveraging advanced technology including AI, biometrics, machine learning, liveness detection and automation, Jumio helps organizations fight fraud and financial crime, onboard good customers faster and meet regulatory compliance including KYC, AML and GDPR. Jumio has carried out more than 500 million verifications spanning over 200 countries and territories from real-time web and mobile transactions.
Based in Palo Alto, Jumio operates globally with offices in North America, Latin America, Europe and Asia Pacific and has been the recipient of numerous awards for innovation. Jumio is backed by Centana Growth Partners, Great Hill Partners and Millennium Technology Value Partners.