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Articles from 2016 In November


New Surgical Robot Offers Millimeter-Scale Precision

The robot, known as Axsis, is one of the world's smallest known robots designed for surgical use and could offer a glimpse into the future of surgical robotic technologies.

Kristopher Sturgis

Engineers from Cambridge Consultants, a product design and development firm out of the UK, announced this week the arrival of Axsis -- a new miniature robotic tool designed to provide increased precision, access, and navigation for a variety of different clinical procedures that current surgical robots cannot perform.

The technology was designed to be the size of a soda can, using flexible instruments that provide the robot with more freedom and mobility to perform precise actions inside the body. Chris Wagner, head of advanced surgical systems at Cambridge Consultants, says that this new robotic technology addresses one of the major challenges to robotic surgery: size. 

Don't miss the BIOMEDevice San Jose conference and expo, December 7-8, 2016.

"One of the main challenges of surgical robotics is how to incorporate the system into the operating room, and the workflow of current procedures," he says. "Current surgical robots are amazing devices, but they are large pieces of equipment that limit their adoption. We've taken a different approach -- using a flexible instrument to articulate inside the body doesn't require large motions outside of the body, nor does it require significant robot forces pushing against the body wall, which allows the robot to be smaller. Thus, the entire system can be made smaller, easing the introduction with current operating rooms and workflows."

The design of the Axsis robotic tool is completely state of the art, aimed at creating space efficiency with the operating room. The size and flexibility of the technology allows for use inside and outside of the body, offering precision on a wide variety of different surgical procedures.

"This flexible approach enables a small robot on the outside of the body, as well as an instrument on the inside of the body," Wagner says. "We've designed our instruments using a stack of rolling stainless steel rings, precision micro-machined to achieve the necessary tolerance and performance. The rings are rolling to provide low friction articulation, as well as made out of metal to achieve a high articulator stiffness. The rings also contain a working channel to allow for fluid management that is normally a part of intraocular tools." 

Wagner says that one reason most current surgical robotic tools are so large stems from the use of long, straight instruments designed to pass through small holes in the body to access surgical sites. This kind of equipment requires large robotic motions outside the body, to create motions inside the body.To address this issue, the group decided to take on the challenge of designing a smaller, more robust robotic technology that could broaden the impact and use of robotic innovation.

"Building a surgical robot that can work on a size scale of less than 10 millimeters is difficult," he says. "So we took it as a technical challenge by asking ourselves, is there anything stopping us from building a robot on this size scale? What we've found so far, is that the answer is no. We've been able to construct articulating end effectors with a 1.8-mm outer diameter that are the same size as current surgical tools, but with full articulation. I think the most exciting aspect for me has been demonstrating that robotics can be applied to a wider range of procedures than ever before, potentially increasing the quality and availability of lifesaving surgical procedures."

Robotics have already begun transforming surgical procedures, despite some questioning their future in medicine. Researchers and engineers have begun to shift to more flexible robotic adaptations--something Axsis aims to do as well. Wagner hopes the new technology could usher in a new wave of miniature robotic systems that could revolutionize some of the more delicate and minimally invasive procedures that require small, precise movements.

"I think the main impact is to demonstrate miniature robotics capabilities that can be incorporated into future products, whether they are full featured surgical robots, or more specialized surgical tools," Wagner says. "One key benefit that robotics can provide is more precise tissue manipulation through motion scaling and tremor reduction, while maintaining minimally invasive access."

When it comes to potential applications, the list could be quite expansive, covering procedures like cataract surgery, to a variety of other delicate procedures like esophageal and gastrointestinal tract procedures. The goal is for Axsis to provide surgeons with a tool that could be used to enable surgical outcomes that are not currently possible today.

"I do think that the benefits that robotics provide will continue to make it into the operating room, and the choice to use a robot for a surgery will become a no-brainer," Wagner says. "We hope that this system demonstrates what's possible in the next generation of surgical robotics, and we hope that this or similar technologies are further developed and the benefits that robotics can bring to surgery become more widespread, thus increasing patient safety and leading to better surgical outcomes. The challenge is on the makers of these tools to ensure they can be provided in a way that is compatible with the workflow and budget of tomorrow's surgeons." 

Kristopher Sturgis is a contributor to Qmed.

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[video courtesy of CAMBRIDGE CONSULTANTS]

Trump Effect Could Dampen December M&A Mania in Medtech

Looking forward to tax breaks promised by the incoming administration, device companies may put off plans to consolidate until next year.

Nancy Crotti

As 2016 winds down, the traditional M&A madness that occurs in the month of December may not happen, as companies await tax breaks and other benefits from the incoming administration of president-elect Donald J. Trump.

Not that 2016 needs the boost. While nothing rivaled Medtronic's nearly $50 billion acquisition of Covidien in 2015, this year has produced some whoppers, including Abbott Laboratories' $25 billion acquisition of St. Jude Medical, which could close by the end of the year.

Still, 2016 hasn't recorded as many multi-billion deals as previous years, according to medtech industry analyst Clyde "Burke" Burkhardt, senior managing director of HT Capital Advisors in New York. However, the volume of deals remained about the same as in 2015 at about 215, Burkhardt noted.

Download our report detailing the medtech mergers and acquisitions of 2015.

The build-up to the presidential election led some smaller companies to seek suitors, spurred by fears that their value would fall and regulations would rise with a Hillary Clinton win, Burkhardt added.

This year also saw some larger companies spin off businesses, further boosting M&A activity. For example, Becton, Dickinson and Co. announced in March that it will sell 50.1% of its respiratory solutions business to funds managed by private equity firm Apax Partners, forming a joint venture that will operate a new independent company. 

Abbott's bid for St. Jude has resulted in more spinoffs. Abbott intends to sell its vision care business to Johnson & Johnson in a $4.325 billion deal expected to close in early 2017. Under pressure from the EU to keep competition alive, Abbott and St. Jude also agreed to sell their vascular closure portfolio and other assets to Japanese multinational Terumo for $1.12 billion. The sale includes St. Jude's Angio-Seal and FemoSeal vascular closure products, as well as Abbott's Vado Steerable Sheath, which would compete with St. Jude's market-leading devices.

The outlook for medtech going into 2017 looks sunny, particularly because of an incoming Trump administration and continued Congressional domination by Republicans.

Trump's presidency promises a permanent repeal of the medical device tax imposed by Obamacare and an easing of medtech regulations. However, it may dampen the traditional flood of M&A deals in December, according to Burkhardt. While some companies may go for it  to save on their 2016 taxes, he believes most will put it off as the election fallout begins in earnest in January.

J&J will probably go shopping. CFO Dominic Caruso told analysts during a third-quarter earnings call in October that the company is looking for "bolt-on acquisitions" in orthopedics and general surgery, according to a transcriptby Seeking Alpha. It could also supplement its electrophysiology business with a structural heart acquisition, Caruso said.

"Generally speaking, we look for a very good year M&A-wise in 2017," Burkhardt said.

Nancy Crotti is a contributor to Qmed.

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[image courtesy of CHANPIPAT/FREEDIGITALPHOTOS.NET]

BD Closing North Carolina Medtech Tubing Plant

About 120 workers will lose their jobs.

Chris Newmarker

LayoffsBecton, Dickinson and Co. says it will close its Creedmoor, NC, facility, which makes medical device tubing.

Franklin Lake, NJ-based BD confirmed its plans to The News & Observer of Raleigh, NC, on Tuesday. Qmed could not immediately reach BD spokespeople for comment.

The roughly 120 workers affected will be laid off over 12 months ending March 2018, with the assembly work going to Mexican plants and the molding going to BD's Sandy, UT, site, the News & Observer relates.

Company spokesperson Troy Kirkpatrick explained to the newspaper that the move is about increasing efficiency and reducing costs to stay efficient.

The Creedmoor plant has specifically made tubing that goes into intravenous pumps employed in hospital settings, according to the News & Observer.

Mexico has been an increasingly attractive location for U.S. medical device companies looking to lower manufacturing costs, according to a recent S&P Global Ratings report. However, the report noted that the strategy could become more risky now that Donald Trump is president-elect. Trump during the campaign suggested there would be consequences for companies that sent their jobs outside the U.S.

BD's roughly $12 billion acquisition of CareFusion, which closed in March 2015, helped boost BD's workforce to 49,517 employees, 18,596 in the U.S., as of September 30, 2015, up from 30,619 employees, 11,965 in the U.S., a year before, according to annual reports filed with the SEC.

As of September 30, 2016, BD's overall workforce had increased slightly to 50,928, while its U.S. workforce was down slightly to 18,480.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image from Pixabay]

What Medtech Is Saying About HHS, CMS Picks

What Medtech Is Saying About HHS, CMS Picks

President-elect Trump has tapped his nominees for Secretary of Health and Human Services and Administrator of CMS. Here are early reactions from around the medtech industry.

As President-elect Trump assembles his Cabinet, he has named two healthcare reformers to key positions. Rep. Tom Price (R-GA) is the nominee for Secretary of Health and Human Services. Seema Verma, MPH is the pick for CMS administrator.

Here is how industry onlookers and stakeholders are reacting to the nominations.

First, an Intro 

As MD+DI's sister publication, Qmed, reported following the announcement, Price spent almost twenty years in private practice as an orthopedic surgeon. It's no surprise then, that he has made healthcare legislation a key focus of his Congressional career. He describes himself in his biography as "a fierce opponent of government waste and devoted to limited government and lower spending."

Price has loudly opposed the Affordable Care Act (ACA) and has previously introduced legislation intended to replace it. He has also supported the Republican "A Better Way" agenda as an alternative to the ACA. He is chairman of the House Committee on the Budget and is a member of the House Committee on Ways and Means. Price is  also a member of the GOP Doctors Caucus and has introduced legislation opposing reforms that he views as harmful to physicians.

Price's nomination is reportedly a key part of efforts to change Medicare and Medicaid, according to Kaiser Health News and other news outlets. Price has also opposed initiatives intended to move healthcare toward value-based care, including the CMS Comprehensive Care for Joint Replacement (CJR) model. The CJR model, which was implemented in April of this year, required hundreds of hospitals to take part in a bundled payment model for joint replacement procedures.

Verma is president, CEO, and founder of national health policy consulting company SVC, Inc. She has a Master's degree in Public Health from Johns Hopkins and is best known for her work on Medicaid reform. According to her biography, she developed the Healthy Indiana Plan (HIP) Medicaid program and worked with Vice President-elect Mike Pence in on HIP 2.0. That program required those receiving coverage to contribute a small monthly payment or risk losing coverage, Kaiser Health News reported.  The IndyStar previously reported on perceived conflict of interest between her insurance reform work and her client relationship with Hewlett-Packard. 

Who Are Key Supporters?

Price has a key ally in House Speaker Paul Ryan (R-WI). In response to Price's nomination, Ryan said in a statement, "This is the absolute perfect choice . . . As a doctor, he has practiced and taught medicine, and he knows exactly how Washington's decisions affect patients. As a legislator, he has played a leading role in developing conservative health care solutions that put patients first."

Healthcare industry groups were quick to get behind the nominations. Patrice Harris, MD, chair of the American Medical Association Board of Trustees, said in a statement, "The American Medical Association strongly supports the nomination of Dr. Tom Price to become the next Secretary of Health and Human Services (HHS) . . . Dr. Price has been a leader in the development of health policies to advance patient choice and market-based solutions as well as reduce excessive regulatory burdens that diminish time devoted to patient care and increase costs. We urge the Senate to promptly consider and confirm Dr. Price for this important role."

Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed) said in a statement, "Rep. Price has been a strong proponent for health care delivery policies that factor in the importance of patient access to medical technology. We look forward to Rep. Price's confirmation as HHS Secretary early next year and to working with him, the new administration and the new Congress on ways to improve the U.S. health care system and advance medical innovation."

Back in August, Price took part in an event focused on veterans' transitions to private careers and the role the medtech industry can play. That event was co-hosted by AdvaMed.

The Medical Device Manufacturers Association (MDMA) also applauded Price's nomination. In a statement, Mark Leahey, MDMA president and CEO, said, "As a surgeon and as a Congressman, [Dr. Price] has been a passionate voice on expanding patient access to treatments that address their specific needs.  If approved by the Senate, MDMA looks forward to working with Dr. Price to ensure that America's patients get timely access to the cures and therapies provided by medical technologies . . . Med tech innovators continue to deliver on the promise of a better tomorrow, and we will also work with Dr. Price to bridge the gap between the regulatory pathways and securing fair reimbursement."

Who Opposes These Picks?

Senator Bernie Sanders (I-VT), issued a statement speaking out against Price's nomination. "Donald Trump asked workers and seniors to vote for him because he was the only Republican candidate who  would not cut Social Security, Medicare and Medicaid--programs that are of life-and-death importance for millions of Americans," Sanders said. "Now, he has nominated a person for secretary of Health and Human Services, Rep. Tom Price, who has a long history of wanting to do exactly the opposite of what Trump campaigned on. Rep. Price has a long history of wanting to cut Social Security, Medicare and Medicaid. What hypocrisy!" 

Senator Charles Schumer (D-NY) said in a statement that he was "incredibly disappointed" by the nomination. "Between this nomination of an avowed Medicare opponent to serve as HHS Secretary and Republicans here in Washington threatening to privatize Medicare, it's clear that Republicans are plotting a war on seniors next year."

Another key opponent of Price? Women's health groups. Cecile Richard, president of Planned Parenthood Federation of America, said in a statement, "From his plan to take no-copay birth control away from 55 million women and allow insurance companies to charge women more for the same health coverage, to his opposition to safe and legal abortion, Price could take women back decades."

An Opinion from Inside the Medtech Industry

George McLaughlin, head of Solution Matching at Redox, a company focused on interoperability challenges within hospitals and health systems, reflected on the nominations in a November 29 Redox blog post. In an excerpt from that post, McLaughlin wrote, 

Funding for initiatives like the  Cancer Moonshot  and Precision Medicine Initiative immediately comes into question. What one administration presented as an opportunity for us to come together and aspire towards, the next may immediately defund and write off as another example of bloated government waste . . .  Both of these appointments mean a drastic change in "business as usual".

Where I see the most hope in these appointments is through Verma and her ability to modify foundational pieces of the Affordable Care Act like the expansion of Medicaid and make them palatable for Conservatives."

McLaughlin summed up his thoughts by writing, "We will be keeping an eye on the fallout just like the rest of the healthcare world but one thing is for sure, buckle in everyone, it's going to be a bumpy ride."

[Image courtesy of CHUCK FELIX/FREEDIGITALPHOTOS.NET]

Trump Taps HHS, CMS Heads

President-elect Trump has nominated Rep. Tom Price to be secretary of Health and Human Services and Seema Verma to head CMS. Here's what to know about the nominees.

President-elect Donald Trump has nominated two people, well-known in the world of healthcare legislation, to head the Department of Health and Human Services and CMS. Trump tapped Representative Tom Price, MD (R-GA) for HHS Secretary and national health policy consultant Seema Verma, MPH for CMS administrator. 

As might be expected, the nominations have drawn opposition from Democrats and applause from Republican leaders like Paul Ryan (R-WI). 

Tom Price, MD

Before entering politics, Price spent almost twenty years as an orthopedic surgeon. According to his official biography, he received his MD from the University of Michigan and did his orthopedic surgery residency at Emory University. Price was an assistant professor at Emory University School of Medicine and was medical director of the Orthopedic Clinic at Grady Memorial Hospital in Atlanta.

After serving in the Georgia State Senate for several years, Price was elected to Georgia's 6th district in 2004. He is currently the chairman of the House Committee on the Budget and also sits on the House Committee on Ways and Means.

Price describes himself in his biography as "a fierce opponent of government waste and devoted to limited government and lower spending."

In his nominating statement, President-elect Trump said, "[Chairman Price] is exceptionally qualified to shepherd our commitment to repeal and replace Obamacare and bring affordable and accessible healthcare to every American. I am proud to nominate him as Secretary of Health and Human Services."

Price has been vocal on a number of healthcare legislation topics, especially in his opposition to the Affordable Care Act (ACA) and reforms that he views as harmful to physicians. 

In an October 20 statement, Price called the ACA President Obama's "disastrous health care law" and said that affordable, accessible healthcare would only "come from patient-centered solutions that actually put patients, families, and doctors in charge of health care in this nation--solutions that Republicans have been fighting for every day since before Obamacare became law."

Price, who has been an active healthcare legislator, introduced his "Empowering Patients First Act" in Congress, most recently in May 2015. He is also part of the House Republican effort to replace the ACA with the "A Better Way" agenda.

Medical device companies have spent the past few years adjusting to the transition to value-based care. Price has opposed CMS efforts to make value-based care mandatory in certain cases. Earlier this year, the Comprehensive Care for Joint Replacement (CJR) Model--a program that required hundred of hospitals to participate in bundled payments for joint replacement procedures--went into effect. In response to the program's implementation, Price said in a statement, "This new, mandatory payment model handed down from CMS comes with tremendous risk and complexity for patients and health care providers. Rushing its implementation would be unreasonable and potentially detrimental to patients and their quality of care."

Price's nomination has drawn the ire of women's health groups, including Planned Parenthood. In a statement, Cecile Richard, president of Planned Parenthood Federation of America, said, "Tom Price poses a grave threat to women's health in the country . . . From his plan to take no-copay birth control away from 55 million women and allow insurance companies to charge women more for the same health coverage, to his opposition to safe and legal abortion, Price could take women back decades."

The American Medical Association (AMA) published a statement of strong support for Price's nomination. Patrice Harris, MD, chair of the AMA Board of Trustees, wrote, "Dr. Price has been a leader in the development of health policies to advance patient choice and market-based solutions as well as reduce excessive regulatory burdens that diminish time devoted to patient care and increase costs." The Advanced Medical Technology Association and the Medical Device Manufacturers Association also issued statements in support of Price's nomination. 

Price said in a statement, "It is an honor to be nominated to serve our nation as Secretary of Health and Human Services . . . There is much work to be done to ensure we have a health care system that works for patients, families, and doctors; that leads the world in the cure and prevention of illness; and that is based on sensible rules to protect the well-being of the country while embracing its innovative spirit."

Seema Verma, MPH

Verma is the president, CEO and founder of SVC, Inc. a consulting company focused on national health policy. According to her biography, she received the Master's degree in Public Health from Johns Hopkins. She was previously the vice president of planning for the Health & Hospital Corporation of Marion County and a director with the Association of State and Territorial Health Officials in Washington, D.C. 

Verma worked with Vice President-elect Mike Pence in Indiana, where she developed the Healthy Indiana Plan (HIP) Medicaid program and worked with Pence on HIP 2.0. She has also worked on reforming Medicaid programs in other states like Iowa, Ohio, Kentucky, Tennessee, and Michigan, according to her biography.

Kaiser Health News reported that HIP 2.0 required people receiving Medicaid coverage to contribute a small monthly payment and that missing a payment could block their access to insurance for six months.

There was some controversy around Verma's work in Indiana, according to the IndyStar, which reported a perceived conflict of interest between her insurance reform work and her client relationship with Hewlett-Packard. 

In his nominating statement, President-elect Trump said, "[Verma] has decades of experience advising on Medicare and Medicaid policy and helping states navigate our complicated systems."

"I am honored to be nominated by President-elect Trump today," Verma said in the statement. "I look forward to helping him tackle our nation's daunting healthcare problems in a responsible and sustainable way."

[Image courtesy of JSCREATIONZS/FREEDIGITALPHOTOS.NET]

A Connected Health How-To

A Connected Health How-To

An expert offers a few tips on creating a differentiated product, understanding users, and how to get customers to keep coming back.

Livongo Health offers a connected glucose meter. Patients with diabetes can access their data and receive coaching using a companion website and app.

Connected health has drawn interest from traditional medtech companies, tech companies, and startups alike. Still, the field is relatively young and best practices for developing and selling a winning product have yet to emerge.

MD+DI asked Patty Spiller, director of marketing at Livongo Health, to share lessons learned from her experience at the Mountain View, CA-based company. Livongo Health offers a connected glucose meter with a companion website and app that simplifies tracking glucose level readings. Patients with diabetes using the product receive tips and insights that can help improve their management of the disease. In addition, they can choose to work with a diabetes educator for coaching and can ensure loved ones have access to important alerts about their glucose levels.

In mid-November, Livongo Health announced its release of over-the-air capabilities with its glucose meter, allowing easy access to new software updates and features.

Hear more from Spiller and her fellow panelists during a panel on "How to Set Your Connected Health Solution Apart" at BIOMEDevice San Jose, December 7-8.

Spiller shared some advice on how to differentiate a connected health solution and how to keep users engaged.

When Livongo Health launched its mobile app, the company's approach was to "learn and iterate fast," Spiller wrote in an e-mail. "The key is to define what is MVP [minimum viable product] to be able to launch fast, with the most fundamental features to get a signal," she added. After the app launch, the company conducted research with user focus group to get a better understanding of their use of the app. That feedback allowed the development team to keep iterating quickly.

It shouldn't be a surprise that the MVP approach, favored by Silicon Valley startups, makes an appearance in connected health too, given the overlaps often seen between connected health offerings and software products.

Livongo Health's offering is unique because "we revolutionized the approach to managing diabetes by focusing on the user/consumer and what their needs are," Spiller wrote. The company, which works with organizations through its Livongo for Diabetes Program, also uses a different method of communicating with patients. "Users hear from us from their employers or payers," Spiller explained. "We have an exclusive channel versus competing out there with all the other media/advertising, etc."

Of course, once a patient is using a connected health product, keeping them happy and interested is another hurdle for most companies. Spiller admitted that this can be a challenge: "Consumers are bombarded with content, apps, etc. outside of healthcare and we're competing with all of that."

She pointed out that in addition to using ideas like gamification to keep users engaged, behavioral economics also have a part to play in crafting messaging to users and encouraging certain behaviors. Part of this requires understanding that users all have differing needs and priorities. "Develop an array of products that will fill the needs of different consumer types," Spiller advised.

Spiller will be part of a panel discussing "How to Set Your Connected Health Solution Apart" at the BIOMEDevice San Jose Conference on December 8. Joining her will be Brit Gould, director of product management at iRhythm and Theo Tam, founder of Zing Health. Kevin Chien, director of global marketing at Stryker, will moderate the panel.

[Image courtesy of LIVONGO HEALTH]

7 Mind-Blowing Medical Biosensors

The global market for medical biosensor technologies continues to see significant growth as demand for new technologies soars. Recent estimates have shown that the global market for biosensing technologies could top $22 billion by 2020, according to a report fromPersistence Market Research, thanks in large part to an increasing demand for point-of-care technologies, as well as a rise in chronic diseases and overall health awareness.As biosensing technologies advance and become more ubiquitous, they have begun to carve out more specialized areas within the medical device realm. From virus and disease detection to rehab and drug dosing, medical biosensors are doing more with each passing year. The following are some of the biosensor applications that could have a significant impact in the medical realm. 

21st Century Cures Act: What's in It for Medtech?

Patient advocates love it, public-health groups hate it, and Senator Elizabeth Warren says it has been "hijacked." But what might the 21st Century Cures Act mean for medtech?

Nancy Crotti

With the 21st Century Cures Act coming up for a vote in the U.S. House of Representatives today, the medtech industry could get some long-hoped for benefits.

It's been a long wait. The House passed its own version of the bill last year, but Senate Republicans wrangled with Democrats over the final language for months, striking a deal last Friday.

Learn from the best minds in medtech and network with your industry peers at BIOMEDevice San Jose, December 7-8, 2016.


The latest version of the $6.3 billion bill could benefit the industry by reducing medical device regulation. It contains provisions to:
 

  • Streamline the FDA approval process for breakthrough devices.
     
  • Allow evidence described in case histories, studies published in peer-reviewed journals, and data collected in other countries to suffice.
     
  • Permit the secretary of Department of Health and Human Services to designate certain types of Class I and II devices to be exempt from the 510(k) approval process.
     
  • Expedite the humanitarian review process and expand it to include diseases and conditions that affect twice as many patients, up to a total of 8,000.
     
  • Streamline clinical trials by reducing duplicate efforts by HHS and FDA.
     
  • Create a streamlined review process for drug-device combinations.
     

The bill also allots $500 million for FDA--much less than Democrats had sought--and $4.8 billion for the National Institutes of Health, down from the original bill's $8 billion.

The final draft of the legislation seeks to boost the efficiency, predictability and transparency of FDA's premarket approval process, according to a previous statement from Whitaker. The most significant change would build on existing resources within FDA to help create an expedited pathway for breakthrough medical technologies, Whitaker said.

"The innovation ecosystem that supports the development of these technologies is severely stressed," he added. "Policy improvements such as those contained in the revised 21st Century Cures legislative package will help strengthen that ecosystem and support the development of life-changing medical technology."

Approval by the House is not a done deal, although the pressure is on for Democrats who want to see it passed before President-elect Trump takes office and disassembles Obamacare.

Republicans demanded including funding sources for the bill, which would also provide $1 billion to states to fight the opioid epidemic, and $4.8 billion to further Vice President Joe Biden's cancer moonshot program, the BRAIN initiative to speed diagnosis and treatment of brain diseases like Alzheimer's, and the President Obama's Precision Medicine Initiative.

Democrats acquiesced, but are not united in their support. Massachusetts Senator Elizabeth Warren ripped the bill Monday, saying it had been "hijacked" by the pharmaceutical industry, according to a report by STAT News.

The bill has drawn kudos from patient-advocacy groups seeking cures for deadly diseases and debilitating conditions, and derision from public health groups concerned about the safety of devices and drugs that undergo expedited approvals. More than 1,300 lobbyists have sought lawmakers' attention on the bill, STAT noted.

"The House vote on Wednesday will be an extraordinary opportunity to help almost every American family," said House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Chairman Lamar Alexander (R-TN), in a joint statement. "What we have in the 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day."

Once the House votes, the Senate will take up the bill before the end of December, according to Senate Majority Leader Mitch McConnell (R-KY).

Nancy Crotti is a contributor to Qmed.

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[image courtesy of SURACHES/FREEDIGITALPHOTOS.NET]

Rupert Murdoch, Other Big Names Invested in Theranos

The beleaguered blood-testing company is also facing a fresh lawsuit from investors.

Jamie Hartford

Australian media mogul Rupert Murdoch and other well-known investors are among those who pumped millions of dollars into Theranos before problems with its blood-testing technology came to light, according to the Wall Street Journal (WSJ). Now, they could lose everything they put in.

Stay on top of the latest trends in connected health by attending the BIOMEDevice San Jose conference, December 7-8, 2016.

Murdoch--who ironically heads News Corp., parent company of the WSJ, which originally brought to light questions about the effectiveness of Theranos's technology in October 2015--invested $100 million in the company, which claimed it could run tests on just a few drops of blood. Other well-known investors named by the WSJ include Riley Bechtel, chairman of Bechtel Corp., a construction and engineering firm founded by his great grandfather; and Cox Enterprises, a privately held conglomerate with divisions covering broadband communications, automotive services, and media. 

In all, Theranos raised an estimated $725 million from outside investors, according to the WSJ article. In 2014, the company was reportedly valued at $9 billion, and its founder, chairman, and CEO Elizabeth Holmes had a net worth of $4.5 billion as late as last year, according to Forbes. This past June, the publication estimated her net worth at nothing.

The same day news of Theranos's high-profile investors broke, the company, Holmes, and COO Ramesh Balwani were also slapped with a fresh class action lawsuit from investors who allege that they made false statements, and misrepresented and omitted facts to get investors to purchase shares in the company. Among the allegations laid out in the lawsuit are that Theranos lied to customers and drugstore chain Walgreens, which had opened testing centers at some of its stores in Arizona and California.

"To them, being honest and forthright was an obstacle to their goals," the lawsuit claims.

Theranos did not respond to Qmed's request for comment.

Jamie Hartford is director of content for medtech brands in UBM's Advanced Manufacturing Group. Reach her at jamie.hartford@ubm.com.

[image courtesy of THERANOS]

Medical Imaging, Powered by IBM

IBM Watson Health and Merge Healthcare are bringing new insights, made possible through artificial intelligence and cognitive computing, to medical imaging.

Dr. Tanveer Syeda-Mahmood developed a tool that uses IBM Watson Health technology to help clinicians detect heart disease. Syeda-Mahmood is an IBM Fellow and chief scientist of the Medical Sieve Radiology Grand Challenge Project at IBM Research.

Radiologists are about to get some help with their imaging workload.

IBM Watson Health and Merge Healthcare, an IBM Company, are showcasing new tools to help clinicians analyze medical images. The offerings use machine learning, artificial intelligence, and cognitive computing to offer additional information that can help tailor diagnosis and treatment decisions.

To give physicians a better understanding of the IBM technology, IBM Research is also conducting a live demonstration of the tools at the Radiological Society of North America Annual Meeting (RSNA) in Chicago, according to a press release.

The release notes that at least 90% of all medical data is images, according to IBM researchers' estimates, and that medical images are growing at the fastest rate of any type of medical data. Accuracy can suffer in the face of all these images that need to be analyzed, referenced, and compared by humans.

An oft-cited Johns Hopkins study published in 2013 revealed how frequently diagnostic errors happen and how devastating they can be. Researches estimated that 80,000-160,000 U.S. patients experience permanent injury or death related to misdiagnosis each year. 

"We designed this Watson-based demonstration to show physicians that soon they can navigate an abundance of digital data--structured and unstructured, text and images--and make informed decisions based on relevant and current information," Dr. Tanveer Syeda-Mahmood, an IBM Fellow and chief scientist of the Medical Sieve Radiology Grand Challenge Project at IBM Research, said in an IBM Research blog post. "More importantly, we can analyze a broad array of medical data and derive Watson-powered insights that are meaningful to doctors."

Don't miss the BIOMEDevice San Jose conference, December 7-8, 2016.

Syeda-Mahmood had a personal reason for her interest in using Watson to help analyze medical images. According to an IBM profile of the researcher, her father suffered a hemorrhagic stroke that was misdiagnosed as an ischemic stroke. He was given blood thinners as a result of this mistaken diagnosis. His condition worsened and he went into a coma. Happily, her father eventually recovered after medical repatriation to India and treatment there.

According to the blog post, that experience drove Syeda-Mahmood to research ways to enable more accurate diagnoses. 

At RSNA, Watson Health and Merge will both showcase new offerings, according to the press release. Watson Health will debut a cognitive peer review tool to clarify differences between a patient's health record and clinical evidence; a cognitive data summarization tool offering personalized patient information for interpretation, diagnosis, and treatment decisions; a cognitive physician support tool to enable personalized decisions using the entirety of patient data; and the MedyMatch "Brain Bleed" App to help diagnose a trauma patient with brain bleed or stroke.

The release also details the products Merge will show, including Marktation, a tool that enables faster image interpretation and will be used first in mammography; Watson Clinical Integration Module, a cloud application that radiologists can use to improve efficiency and reduce errors; and the Lesion Segmentation and Tracking Module, to allow faster interpretation and reporting of comparison exams.

"Watson cognitive computing is ideally suited to support radiologists on their journey 'Beyond Imaging' to practices that address the needs of patient populations, deliver improved patient outcomes, and demonstrate real-world value," said Nancy Koenig, general manager of Merge Healthcare, in the release. "This week at RSNA, Merge is proud to unveil solutions for providers that enable the first steps on the cognitive care journey, addressing breast cancer, lung cancer, and trauma patients in the ER."     

[Image courtesy of IBM RESEARCH]