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Modernizing the federal Anti-Kickback Statute is long overdue and will improve patient care

modernizing the federal anti-kickback statute is long overdue and will improve patient care

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In the face of the worst pandemic in memory, we’ve seen heroes emerge in hospitals, doctors’ offices and across the healthcare industry. It has become clear that patients rely on more than just their primary physician to receive the care they need, with many others, including the medical technology industry, playing a pivotal role in patient health. 
Unfortunately, a law written back in the 1970s—the federal Anti-Kickback Statute—today deters coordination among healthcare providers, and between providers and medtech companies, that would achieve better and lower-cost outcomes for patients. 
The law was enacted to stop fraud and abuse nearly five decades ago (back when the hottest technology was the eight-track tape), in what was a predominantly fee-for-service system. The law rightly prevented providers from referring patients to other entities for services that would financially benefit themselves.
While the law was and still is critically important, our system has changed so much that it’s crucial to update the statute to reflect the more integrated way our health system works today—including the role medtech companies play in providing more patient-centered, value-based care that helps achieve better clinical outcomes, lower costs and increased accountability.
Medtech companies today can provide …

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DTW Podcast: Hear the future of AI, 3D, and Dx from Edwards, Stryker, Evercore, Checkable – MassDevice

dtw podcast: hear the future of ai, 3d, and dx from edwards, stryker, evercore, checkable – massdevice

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DeviceTalks Weekly
In this week’s episode of DeviceTalks Weekly we review the Medical Design & Outsourcing’s Women in Medtech issue bringing you insights through interviews with Katie Syzman, corporate VP and the GM of critical care at Edwards Lifesciences, Naomi Murray, Stryker’s director of advanced operations, and Patty Post, CEO of Startup Checkable Medical.
Szyman will share Edwards’ view of artificial intelligence.
Murray will reveal her future vision on additive manufacturing while Post will share the lessons learned in her first post as startup CEO of a diagnostic company.
In our closing keynote conversation, Vijay Kumar, managing director at Evercore ISI, will explain why Exact Science’s acquisition of liquid biopsy company wasn’t exactly a surprise (though the $2 billion pricetag might have been.) He also assesses Boston Scientific’s COVID-19 comeback. What does the rise in cases mean for the company and the rest of medtech?
Chris Newmarker, executive editor of life sciences, delivers this week’s Newmarker’s Newsmakers which highlights reports on Abbott, Baxter, Intuitive Surgical and Siemens. Editor Danielle Kirsh also is on hand to talk through MassDevice Big 100 report. Assistant editor Sean Whooley also joins the conversation.

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ResMed shares get boost from Street-beating Q1 – MassDevice

resmed shares get boost from street-beating q1 – massdevice

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ResMed (NYSE:RMD) shares ticked up today on first-quarter results that came in well ahead of the consensus forecast.RMD shares were up 6.6% at $191.33 per share in mid-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -1.1%, while the Dow Jones Industrial Average was down -1.4% at the same time.
The San Diego-based company posted profits of $178.4 million, or $1.22 per share, on sales of $751.9 million for the three months ended Sept. 30, 2020, for a 48.5% bottom-line gain on sales growth of 10.4%.
Adjusted to exclude one-time items, earnings per share were $1.27, 24¢ ahead of Wall Street, where analysts were looking for sales of $710.7 million.
ResMed attributed much of its revenue growth to the increased demand for its ventilator products during the COVID-19 pandemic. However, that was partially offset by a decrease in demand for sleep devices.
“Our first-quarter results reflect solid performance and positive trends across our business,” ResMed CEO Mick Farrell said in a news release. “During the quarter, we continued to support the global COVID-19 pandemic response, providing ventilators, masks, and circuits to countries in need around the world. In our core markets of sleep apnea, COPD and asthma, we are …

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Vigilent Labs Investing $104.6M In South Carolina

vigilent labs investing $104.6m in south carolina

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Vigilent Labs, an advanced health and medical technology company, will establish operations in Charleston County, SC. The company will invest more than $104.6 million and create over 400 new jobs at its state-of-the-art COVID-19 test manufacturing facility in the Charleston Navy Yard.“We are so honored by this substantial support from Governor McMaster, Secretary Hitt, the Coordinating Council and Charleston County to center our Vigilent Labs at the historic Charleston Navy Yard in South Carolina,” said Vigilent Labs President John Falk. “This new facility will specialize in state-of-the-art health and bio-threat testing, screening technologies and products that will help address the expanding need for reliable and accurate COVID-19 testing to confront this pandemic. The Governor, Secretary of Commerce, Charleston County and their teams truly went above and beyond the call of duty to welcome us, attract us and support us, and we are so proud to claim South Carolina as home.” (Credit: Getty Images/anyaivanova)Established in 2019, Vigilent Labs provides unique solutions to the detection, identification and assessment of health and bio-threats. The company’s team has substantial experience in the development of medical and bio-surveillance technologies as well as medical devices.Vigilent Labs’ new operations in North Charleston will serve as …

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The most innovative medical device of 2020 – MassDevice

the most innovative medical device of 2020 – massdevice

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The MitraClip TMVR device [Image courtesy of Abbott]Abbott (NYSE:ABT) announced today that it received the 2020 Prix Galien USA Award for Best Medical Technology for its MitraClip system.
MitraClip, Abbott Park, Ill.-based Abbott’s minimally invasive transcatheter mitral valve repair (TMVR) system, was chosen from a field of 17 other nominees, according to a news release. MitraClip is delivered to the heart through a vein in the leg and clips portions of the leaflets or flaps of the mitral valve together to reduce the backflow of blood.Last month, Abbott’s fourth-generation MitraClip won CE Mark approval as a non-surgical option for treating mitral regurgitation (MR) or a leaky heart valve. The device already has approval in the U.S., having won an FDA nod in July 2019. The MitraClip system secured its first FDA approval in 2013 and, in January of this year, the FDA approved a clinical trial to study the effectiveness of MitraClip in people eligible for open-heart surgery.
The victory is Abbott’s second in as many years in the category, having received the award for its FreeStyle Libre 14-day system for continuous glucose monitoring in 2019.
“MitraClip is a first-of-its-kind, life-saving device that has transformed the lives …

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‘TrueFuture Israel’ Showcases Israeli People, Places and Cutting-Edge Tech Innovations

‘truefuture israel’ showcases israeli people, places and cutting-edge tech innovations

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While Israel is widely known for its rich history and culture, it has also become a leading center of health and medical technology, developing cutting-edge breakthroughsin medical devices, robotics and artificial intelligence. In the eight-part online TV docuseries “TrueFuture: Israel,” tech entrepreneur Joe Mullings introduces viewers to the Israeli visionaries whose discoveries are changing the world, while soaking up the local culture in Jerusalem, Tel Aviv and elsewhere. New episodes will post every two weeks at TrueFuture.tv.
“What we tried to do in every episode was demonstrate the old, the new, the future, the prospective, and the humanity in the middle of it,” Mullings told the Journal. “There were so many things to shoot and capture. We had an unbelievable crew and the government was so welcoming to us. The challenge was we didn’t have enough time. I’m pretty sure we’ll go back for a part two of the series after the pandemic, whenever that is.”
Over 10 days in the fall of 2019, Mullings visited a children’s hospital with an on-site medical device development lab; had a seder meal with successful female tech entrepreneurs; learned how a thumbnail-size robot, implanted in the brain, can prevent the …

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New project to develop surgical technologies for COVID-19 receives €2.4 million funding

new project to develop surgical technologies for covid-19 receives €2.4 million funding

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Reviewed by Emily Henderson, B.Sc.Oct 30 2020
Irish medical tech firm Palliare leads EU H2020 research project with UCD using innovative optical technology for new safer surgery solution.

An R&D project to develop new technology to protect surgeons and patients from COVID-19 has received €2.4 million funding from the European Commission.

The rapid 18-month consortium project, PORSAV, is being led by Irish medical technology firm Palliare, in collaboration with University College Dublin (UCD), as well as Polish medical device manufacturer SteriPack and leading French institution for surgical training IRCAD, and project managed by Pintail Ltd.

UCD Digital Surgery, led by Professor Ronan Cahill and joined by Dr Kevin Nolan from UCD School of Mechanical and Materials Engineering, is leading academic partner on the project funded under Horizon 2020. UCD Digital Surgery is based at Mater Misericordiae University Hospital, Dublin, and is part of UCD Centre for Precision Surgery.

The UCD team will examine the nature and extent of unintended gas leaks during surgical and non-surgical procedures such as keyhole surgery, endoscopy and intubation – where the aerosolization of body fluids poses a high risk to healthcare staff.

In general, the problem arises when small amounts of gas used during surgical procedures …

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New project to develop surgical technologies for COVID-19 receives €2.4 million funding

new project to develop surgical technologies for covid-19 receives €2.4 million funding

BEGIN ARTICLE PREVIEW:

Reviewed by Emily Henderson, B.Sc.Oct 30 2020
Irish medical tech firm Palliare leads EU H2020 research project with UCD using innovative optical technology for new safer surgery solution.

An R&D project to develop new technology to protect surgeons and patients from COVID-19 has received €2.4 million funding from the European Commission.

The rapid 18-month consortium project, PORSAV, is being led by Irish medical technology firm Palliare, in collaboration with University College Dublin (UCD), as well as Polish medical device manufacturer SteriPack and leading French institution for surgical training IRCAD, and project managed by Pintail Ltd.

UCD Digital Surgery, led by Professor Ronan Cahill and joined by Dr Kevin Nolan from UCD School of Mechanical and Materials Engineering, is leading academic partner on the project funded under Horizon 2020. UCD Digital Surgery is based at Mater Misericordiae University Hospital, Dublin, and is part of UCD Centre for Precision Surgery.

The UCD team will examine the nature and extent of unintended gas leaks during surgical and non-surgical procedures such as keyhole surgery, endoscopy and intubation – where the aerosolization of body fluids poses a high risk to healthcare staff.

In general, the problem arises when small amounts of gas used during surgical procedures …

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