Sterilization plant closures: Here’s why you need to care

(Image by Jose Fontano on Unsplash)

The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant.

Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. With a Viant sterilization plant in Grand Rapids, Mich. slated to close later this year, the FDA is warning of spot shortages, and smaller medtech companies may be the hardest hit.

Get the full story on our sister site, Medical Design & Outsourcing.

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Nevro taps ex-Thoratec CEO Grossman | Personnel Moves, March 20, 2019

Nevro taps ex-Thoratec CEO GrossmanNevro Corp. (NYSE:NVRO) said yesterday that it named former Thoratec CEO Keith Grossman to replace president & CEO Rami Elghandour after striking a deal with one of its investors, Broadfin Capital.

Grossman re-joined Thoratec after taking over at Conceptus in December 2011 and leading it to a $1.1 billion sale to Bayer in June 2013 (he’d been Thoratec’s CEO from 1996-2006). Grossman helmed Thoratec until St. Jude Medical (now Abbott) acquired it in October 2015 for $3.3 billion.

Nevro said the deal with Broadfin also involves the expansion of its board of directors with the addition of Warburg Pincus limited partner Bess Weatherman and medtech veteran Kevin O’Boyle and the departure of director Ali Behbahani. Broadfin picked up a 5.8% stake in Nevro in September 2015 but cut that to less than 0.2% in February 2017, according to regulatory filings.

“On behalf of the board and our entire company, I am excited to welcome Keith Grossman to the Nevro team,” chairman Michael DeMane said in prepared remarks. “Keith brings over 30 years of experience in leading innovative medical technology companies through periods of strategic change to deliver growth and enhanced value for stockholders. As we look to the future, I am confident that under Keith’s direction, Nevro will be well positioned to capture a burgeoning market opportunity with its pioneering spinal cord stimulation (SCS) technology to treat chronic pain.”

“I am excited by this opportunity to join such a talented team at a pivotal moment in Nevro’s history,” Grossman added. “Over the past several years, Nevro has leveraged the strength of its technology to enhance patient care and drive overall industry growth. Nevro is now at an inflection point, and I am confident in our ability to continue delivering value not only to our patients and customers, but importantly, to our stockholders. I look forward to working closely with the board and the full Nevro team to advance the company into its next phase of growth.”

Broadfin also agreed to back Nevro’s board nominees at its next shareholders meeting and to obey standstill provisions and voting commitments. Nevro said it’s suspending its revenue guidance pending Grossman’s assessment.

NVRO shares were up 25.0% to $55.96 apiece today in pre-market trading ahead of a $44.51-per-share open and jumped 33.8% to $59.91 shortly thereafter.

 Synaptive Medical names Clarke as CFO
Synaptive Medical said it named Sandra Clarke as its new finance chief.

“Ms. Clarke is an incredible addition to our team,” CEO Peter Wehrly said in prepared remarks. “With her accomplished background and experience working for companies at critical inflection points, Ms. Clarke will play a key role at Synaptive as we continue expanding our presence globally.”

“I’m very excited to join Synaptive and work closely with the team to continue advancing their efforts in transforming neurosurgical technologies,” Clarke added. “Given the increasing need for advanced neurological care, I’m pleased to be working for a company that is committed to providing physicians the tools necessary to achieve optimal patient outcomes.”
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 ElectroCore CFO Vraniak taps out, Posner taps in
ElectroCore CFO Glenn Vraniak is resigning effective April 1 and is to be replaced by Cellectar Biosciences finance chief Brian Posner.
Read More

 Rosenzweig joins Check-Cap as CFO
Check-Cap (NSDQ:CHEK) said it appointed former Entera Bio (NSDQ:ENTX) CFO Mira Rosenzweig as its own finance chief, effective April 28.
Read More

 Ex-K2M CIO Staubach lands at Tactile Medical
The new chief information officer at Tactile Systems Technology (NSDQ:TCMD) is ex-K2M CIO Peter Schaubach.
Read More

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Medical device tax repeal bill reintroduced in U.S. Senate

medical device taxU.S. Senator and Democratic presidential candidate Amy Klobuchar (D-Minn.) reintroduced a bill to permanently repeal the 2.3% federal excise tax on medical device sales, with a new co-sponsor. Sen. Pat Toomey (R-Penn.) has signed on to co-sponsor, replacing Sen. Orrin Hatch (R-Utah), who did not run for re-election last fall.

The medical device tax went into effect in 2013 and has been suspended twice. One two-year pause ended in January 2018 and the second moratorium is due to expire at the end of 2019. The tax on the sale of most medical technologies was enacted as part of the Affordable Care Act and applies to medtech companies’ revenues, not profits. In 2018, the U.S. House of Representatives passed a bill to repeal the tax 283-132, but the Senate failed to act.

In February, U.S. Rep. Ron Kind (D-Wis.) inked a letter to colleagues in the House of Representatives seeking support for a new bill to repeal the tax. The House version of the Protect Medical Innovation act of 2019 already has backing from Jacki Walorski (R-Ind.), Scott Peters (D-Calif.), Richard Hudson (R-N.C.), Terri Sewell (D-Ala.), Darin LaHood (R-Ill.), Suzan DelBene (D-Wash.) and Jason Smith (R-Mo.).

Kind would be stepping in as lead sponsor for former Congressman Erik Paulsen (R-Minn.), a longtime champion of the legislation who lost his re-election bid to Democratic newcomer Dean Philips.

In his letter to colleagues, Kind called the 2.3% excise tax “extremely punitive to medical technology investors,” and said that since its inception there has been “growing bipartisan support” to end it.

The Senate bill has attracted nine senators each from both the Democratic and Republican parties. They include Lamar Alexander (R-Tenn.), Dick Blumenthal (D-Conn.), Bob Casey (D-Pa.), Mike Crapo (R-Idaho), Tammy Duckworth (D-Ill.), Chuck Grassley (R-Iowa), Maggie Hassan (D-N.H.), Jim Inhofe (R-Okla.), Johnny Isakson (R-Ga.), Doug Jones (D-Ala.), Martha McSally (R-Ariz.), Rob Portman (R-Ohio), Jacky Rosen (D-Nev.), Jeanne Shaheen (D-N.H.), Kirsten Sinema (D-Ariz.), Tina Smith (D-Minn.), Thom Tillis (R-N.C.), and Todd Young (R-Ind.).

Medtech trade group AdvaMed continues to drum up support for a permanent repeal of the tax, saying that short-term suspensions limit the ability of companies to make longer-term investments in new technologies and treatments.

“Unless Congress acts quickly, America’s medical technology companies face a $20 billion tax hike at the end of 2019 when the device excise tax returns,” said AdvaMed president and CEO Scott Whitaker in a prepared statement. “If not stopped, this tax will put future patient innovations and good-paying U.S. jobs at risk.”

AdvaMed, the Medical Device Manufacturers Association (MDMA) and Minnesota-based trade group Medical Alley each thanked the Senate bill’s lead sponsors for taking it up again.

“We are grateful to Senator Klobuchar for her bill to once and for all repeal the medical device tax,” said Medical Alley president & CEO Shaye Mandle. “Medical device companies have been subject to great uncertainty because of this tax, limiting their ability to invest in the life-saving research they’re capable of producing.”

“When the medical device tax was in place, billions of dollars were sent to the I.R.S. instead of being invested in the next generation of cures and therapies for patients. We simply cannot allow this to happen again, and today’s introduction of the ‘Protect Medical Innovation Act’ shows that a broad, bipartisan coalition in the Senate agrees,” added MDMA president & CEO Mark Leahey. “MDMA thanks Senators Toomey and Klobuchar and all the original cosponsors for their ongoing leadership on this crucial issue for medical innovation and patient care, and we remain committed to working with them and all of the stakeholders who recognize how destructive the medical device tax is.”

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Trump, industry groups praise outgoing FDA chief Gottlieb

FDA's Dr. Scott GottliebIn the wake of the surprising news that FDA commissioner Dr. Scott Gottlieb plans to resign next month, the Trump Administration and industry groups expressed support for the outgoing chief.

In a letter to FDA employees, Gottlieb said that the challenge of being apart from his family for the last two years motivated his decision to leave. An administration official told CNN that Gottlieb has been commuting weekly from his home in Connecticut to Washington.

During his tenure at the FDA, Gottlieb oversaw a record number of approvals for new drugs and therapies. He focused his policy priorities on dealing with opioid addiction and e-cigarettes.

Gottlieb also dealt with overseeing the FDA during the longest government shutdown in history, as well as navigating the difficulties presented by natural disasters.

Secretary of the Dept. of Health & Human Services Alex Azar wrote that Gottlieb has been “an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”

The president took to Twitter to support Gottlieb.

“Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plasn to leave government service sometime next month,” he wrote. “Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!”

Medical device industry groups also commented on Gottlieb’s departure.

“Commissioner Gottlieb has been a tremendous leader in supporting patient care and medical technology innovation, and he has initiated regulatory reforms that will impact our ecosystem for years to come. MDMA thanks Commissioner Gottlieb for all of his passionate work, and we look forward to continue working with the Administration, FDA, Congress and all stakeholders to ensure that patients have timely access to safe and effective medical technologies,” Mark Leahey, president & CEO of the Medical Device Manufacturers Association, said in prepared remarks.

“We want to thank Dr. Gottlieb for his service to the American public and his commitment to ensuring patients have access to the latest treatments, diagnostics and cures. During his tenure as FDA commissioner, Dr. Gottlieb has been a tireless advocate for improved patient care and for promoting innovative solutions to our most pressing health challenges, including greater use of medtech to combat the opioid crises. We wish him well in his future endeavors,” AdvaMed president & CEO Scott Whitaker said in a statement.

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Sen. Warner enlists healthcare industry help on cybersecurity


[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]

U.S. Senator Mark Warner (D-Va.) is wrote a letter to several healthcare organizations yesterday, asking their help in improving cybersecurity in the industry.

A member of the Senate Finance Committee and chair of the Senate cybersecurity caucus, Warner pointed to apparent gaps in oversight, expressed concern about the impact of cyberattacks on the health care sector, and said he wants to help develop strategies that strengthen information security.

Ransomeware and other cyberattacks have stunned the healthcare industry. The 2017 WannaCry attack affected hospitals in the U.S. and U.K., including medical devices made by Bayer, Siemens and others, according to the Health Information Trust Alliance. A 2017 report by internet security software company Trend Micro found that more than 100,000 medical devices and systems were exposed directly to the public internet. The U.S. Department of Homeland Security issued an alert in 2018 indicating that several GE Healthcare imaging devices were vulnerable to cyberattack.

Healthcare hacking incidents accounted for 44% of all tracked data breaches in 2018,  the most of any type of breach, according to a report published in HIPAA Journal.  FDA published an updated draft of its cybersecurity premarket guidance for medical device makers in October 2018.

Warner’s office sent the letters to medtech trade group AdvaMed, the Healthcare Information and Management Systems Society, the American Hospital Association, and several other organizations.

“I would like to work with you and other industry stakeholders to develop a short and long term strategy for reducing cybersecurity vulnerabilities in the health care sector,” Warner said in the letter. “It is my hope that with thoughtful and carefully considered feedback we can develop a national strategy that improves the safety, resilience, and security of our health care industry.”





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AdvaMed president & CEO Scott Whitaker to participate in keynote interview at DeviceTalks Boston 2019

DeviceTalks Boston 2019 - Scott WhitakerWTWH Media and announced today that Scott Whitaker, president and CEO of AdvaMed, will be a featured keynote speaker at DeviceTalks Boston 2019.

DeviceTalks Boston, which takes place on June 5-6, 2019 at the Seaport World Trade Center, brings together engineering, product development and commercialization professionals to share the challenges and best practices of getting medical devices to the market.

“We are very excited that Scott Whitaker will provide the DeviceTalks Boston audience with an inside look at AdvaMed’s priorities for 2019. Scott is a leading voice in the medical device industry, helping to shape the policies that affect every device company. The DeviceTalks team is thrilled that he will join us in June for our eighth year in Boston,” said DeviceTalks content manager Sarah Faulkner.

“It’s a pleasure to be returning to Boston for DeviceTalks in June, and also for The MedTech Conference powered by AdvaMed this September,” Scott Whitaker said. “Boston is at the epicenter of medtech innovation across the region, helping to provide life-changing solutions for patients around the world, and we’re excited to be there.”

Recruiting from the best of Boston’s medtech ecosystem, DeviceTalks Boston highlights speakers who explore how to build better devices and better companies. To register, visit

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3M names CEO Roman as board chair | Personnel Moves – February 7, 2019

3M CEO Roman

3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire.

The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14.

“Under Inge’s leadership, 3M evolved into a more agile and competitive enterprise while generating tremendous value for customers and shareholders. Today’s decision underscores the Board’s confidence in Mike’s leadership and strong character to lead 3M into the future as both CEO and chairman of the board,” board independent lead director Mike Eskew said in a prepared statement.

“I am proud of 3M, our people, and what we’ve accomplished together. I’ve known and worked very closely with Mike, including since his appointment as CEO. I’m very confident that 3M’s best days are ahead and Mike will do a fantastic job leading 3M into the future,” Thulin said in a press release.

“It’s an honor to be nominated to the additional role of chairman of the board. I thank Inge for his leadership and partnership throughout my career, especially over the past year in his role as executive chairman,” Roman said in prepared remarks.

 VentureMed names former NxThera prez Paulson as CEO

VentureMed said on Tuesday that it named former NxThera prez & CEO J. Robert Paulson, Jr. as its new prez & chief executive, effective January 1.

Paulson will replace Gary Smith, who the Toledo, Ohio-based company said will continue to serve as a member of the leadership team.

Prior to joining VentureMed, Paulson served as prez, CEO and board director of NxThera from 2009 until the company’s acquisition by Boston Scientific (NYSE:BSX) last year.

Before joining NxThera, Paulson also held president and CEO positions with Restore Medical, which was acquired by Medtronic (NYSE:MDT) in 2008.

“Bob brings tremendous knowledge and experience to the VentureMed Group, together with a strong track record of building successful teams and commercializing compelling new medical technologies. We look forward to Bob’s contributions and leadership during this next phase of the company’s growth. On behalf of the board of directors, I would like to thank Gary for his significant contributions, which have created a solid foundation for the future success of the VentureMed Group,” board member and Endeavour Vision partner Alexander Schmitz said in a press release.

“I am thrilled to be working with our team and physician partners to expand adoption of our Flex VP System, to improve the treatment of peripheral arterial disease, and AV fistulas and grafts, in millions of patients around the world,” Paulson said in a prepared statement.

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 Repro-Med Systems lifts prez & CCO Petigrew to the corner office

Repro-Med Systems said on Monday that its reconstituted board of directors promoted prez & CCO Don Petigrew to the position of CEO.

Petigrew will replace interim CEO and chair Dan Goldberger, who is assuming the position of exec board chair, the Chester, N.Y.-based company said.

“As an industry leader in the home infusion market, RMS delivers invaluable medical and lifestyle solutions to patients who rely on our products. My vision as CEO is to innovate and improve our products such as the FREEDOM system, partner with the medical community to identify new patient needs and expand our reach in the US and abroad. Achieving these goals is a win-win for patients, providers and shareholders alike,” prez & CEO Petigrew said in a prepared statement.

“Don’s presence since joining the company has been immediately accretive. His experience in the infusion industry has uniquely positioned him to build upon the company’s successful foundation. I look forward to working with Don and the team at RMS and our newly reconstituted Board of Directors in my role as Executive Chairman to help the company achieve its potential and execute on our strategy,” exec chair Goldberger said in a press release.

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 Myomo taps Henry as CFO

Myomo said yesterday that it named David Henry as its new CFO, taking over for current chief financial officer Ralph Goldwasser, who is retiring effective February 18.

The Cambridge, Mass.-based company said that Goldwasser will stay on to help in the transition for an anticipated three months.

Prior to joining Myomo, Henry served as chief financial officer of Eos Energy Storage, and has also held CFO positions with American Semiconductor Corp and AMI Semiconductor.

“I would like to thank Ralph, who has worked with me at Myomo for the past eight years, first as a consulting CFO and later as our chief financial officer, enabling us to raise growth capital, including leading our June 2017 IPO and listing on the NYSE American exchange and our follow-on equity financing in December of 2017. We wish Ralph the best in his retirement. We are pleased to have David Henry join Myomo’s executive team as chief financial officer. David has extensive experience to support our efforts to grow the company,” chair & CEO Paul Gudonis said in a press release.

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 Amazon, Berkshire Hathaway & JP Morgan venture snags Kutan as CTO

The joint healthcare venture between Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan Chase has picked up former tech chief at digital healthcare startup ZocDoc Serkan Kutan as its new chief technology officer, according to a recent CNBC report.

The move was confirmed as official by the new health venture, according to the report.

“I am thrilled to now announced that I am serving as CTO of this new venture,” Kutan wrote in a LinkedIn posting, according to CNBC.

During his time at ZocDoc, Kutan was tasked with building technology allowing consumers to book doctors appoints digitally, according to the report.

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FDA opts not to change device class definitions

FDA-logo-newThe medtech industry appears to have won a round in the regulatory arena.

The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.”

When it was proposed in 2014, the rule drew comments from the industry arguing that the changes in definitions would result in more devices being classified into “burdensome, higher-class device categories, particularly into class III.”  Other commenters said the changes would make class definitions too specific and narrow, particularly for class III devices. This could lead to “unwarranted reclassification of high-risk devices into lower classes,” the document says.

AdvaMed and the Medical Device Manufacturers Association were among those that warned the definition changes would result in more devices being classified as posing a high risk to human health.

“MDMA is concerned that the Proposed Rule creates an unjustified and, indeed,
what we believe is an unlawful burden on industry that will result in significant delays in patient access to critical new products,” the organization wrote.

In its objection, AdvaMed wrote that the proposed changes amounted to “substantial rewriting of the device class definitions, changes in well-settled terminology, and new definitions with likely significant impact on the reclassification process.”

“We believe that unsettling longstanding understandings of the classification
process and attempting to integrate decision-making criteria into definitions that do not need clarification is a dangerous practice that can create confusion, inefficiency and weak decision-making for both the regulators and regulated persons,” AdvaMed continued. “In other words, we believe the proposed revisions will cause confusion where there was none.”

Others said that the proposed definition of class II was too broad and that it would capture devices that they thought should be regulated as class III.

In the end, the FDA decided not to finalize any of the proposed definition changes.

“We do not believe, given the volume and diversity of opposing comments, that finalizing these definitions would add clarity or transparency to stakeholders’ understanding” of the regulation, the agency said.

The decision to pull back on its definition changes was the second in two weeks that could affect the classification of devices. Last week, the FDA published a new proposed rule looking to establish procedures and criteria for its De Novo certification pathway.

If finalized, the rule would establish classifications for new types of medical devices and provide guidelines for the de novo classification process. It would also establish requirements for the formatting and content of de novo requests and would clarify the agency’s criteria for approval, declining and withdrawing such requests.

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Medtech companies, industry groups shrug off ICIJ’s “Implant Files” report

Medtech companies and industry groups have shrugged off the recently released “Implant Files” report from the International Consortium of Investigative that was highly critical of the industry, seeing shares stay steady or rising only days after the report was posted.

The highly critical “Implant Files” report, which was released early this week, is a collaborative effort overseen by the ICIJ and includes work from 252 journalists from 59 media groups across 36 countries.

On its first day of trading this week after the release of the report, industry giant Medtronic (NYSE:MDT) saw its shares rise 1.6% to close at $92.06. Other major players, including Johnson & Johnson (NYSE:JNJ), Boston Scientific (NYSE:BSX) and Zimmer Biomet (NYSE:ZBH) saw shares drop less than 1% in response to the report.

Responses from medical device industry groups varied greatly, with some expressing sympathy to the issues presented in the report and reiterating their intentions to improve global health and wellness through the use of advanced technology.

“The medical device industry understands that just one adverse event is too many, particularly if it affects you or your loved ones. It is heartbreaking when our healthcare system, which is set up to heal people, results in patients being harmed. Everyone involved in care feels the pain when a patient is hurt, from the nurses and doctors on the front lines of care, to the women and men building medical technology. Our first and primary purpose is to help patients and we do that, every day for millions of people around the globe,” MassMEDIC president & former MassDevice publisher Brian Johnson wrote in a statement in response to the ICIJ report. “Patients can feel confident that the medical devices being used to treat them are safe and have been rigorously vetted by a robust and stringent regulatory system. Independent research has shown that the overall recall rate of medical devices, cleared through the FDA is remarkably low, less than 1%. However, nobody involved in this system believes in resting on their laurels. The medical device industry, the FDA and our healthcare system will continue to seek ways to improve the process of patient safety, while giving patients access to groundbreaking new treatments that will improve their lives.”

“While there is no medical procedure that can be performed without risk, Medical Alley companies always strive to innovate and produce the safest possible technologies that deliver better outcomes for patients. Medical Alley has a history of leadership, as the birthplace of the modern medical technology industry and as the co-creator of the Medical Device Innovation Consortium. Medical Alley looks forward to working with all health stakeholders to improve the products, the regulatory process and the press coverage of the medical technology industry and the patients whose lives depend on these products,” Minnesota’s Medical Alley Association representatives wrote in response to the report.

Other groups were more dismissive of the issues covered in the release and accused investigators of “cherry-picking” dramatic stories and “overlooking the overwhelmingly positive experiences” that the industry supports.

“The ICIJ’s coverage of this dynamic industry is cherry-picking a handful of adverse outcomes at the exclusion of the nearly 200,000 medical devices currently on the market improving patient care. This only serves to frighten the millions of patients who benefit from medical technology innovation every day, while inaccurately portraying the rigorous regulatory pathways that are in place to ensure patient safety,” Medical Device Manufacturer’s Association prez & CEO Mark Leahey said in press release responding to the ICIJ report.

“Every one of us will inevitably face a moment where we will hope for a miracle to make a child, sibling, parent, grandparent or loved one well again. Whether it’s a pacemaker that keeps a heart beating, an implant that allows a child to hear for the first time, or an artificial knee that allows a grandmother to play with her grandkids, medical devices are the foundation of modern medicine, providing physicians and nurses the tools they rely on to improve patient care. Yet, instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide,” AdvaMed wrote in response to the ICIJ report. “We should never discount any patient’s experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others. We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery.”

The report is the second major examination of the medtech industry to release this year, after Netflix released a highly critical documentary, titled “The Bleeding Edge,” earlier this summer.

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Is the medical device industry endangering people?

(Image from Unsplash)

The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny.

The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about medtech companies, the FDA and the European device approval system, a new International Medical Devices Database, resources for patients, and a list of its many international media collaborators. Investigators collected more than 8 million device-related health records over the course of the investigation, the majority of which came from the more than 5.4 million adverse event reports filed with the FDA over the past 10 years.

Get the full story on our sister site, Medical Design & Outsourcing,

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