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| Apr 18, 2025 | The Tariff Tug-of-War: Medical Manufacturers at a Crossroads | In the world of medical technology, tariffs are more than just numbers. They are the unseen hands that shape the landscape of healthcare. The recent imposition of tariffs by the Trump administration has created a rift among medical product ... |
| Apr 16, 2025 | Medical product manufacturers are divided over Trump’s tariffs | Medical technology, medical device and hospital trade groups are pushing the Trump administration for tariff exemptions on medical equipment
Consultants at PwC and BCG say manufacturers are looking to switch production to lower-tariff count... |
| Apr 3, 2025 | Executives, trade and labor associations on Trump's reciprocal tariffs | President Donald Trump said on Wednesday he would impose a 10 per cent baseline tariff on all imports to the United States and higher duties on some of the country's biggest trading partners, a move that could escalate a trade war and upend... |
| Mar 4, 2025 | National Politics | Trump says Zelenskyy wants peace, ready to accept minerals deal after WH blowup | Vice President JD Vance, right, speaks with Ukrainian President Volodymyr Zelenskyy, left, as President Donald Trump listens in the Oval Office at the White House, Friday, Feb. 28, 2025, in Washington. (AP Photo/ Mystyslav Chernov)
Trump ad... |
| Feb 24, 2025 | National Politics | FDA moves to rehire medical device staffers fired only days earlier | “This would be welcome news, and I appreciate the administration for acting quickly,” AdvaMed CEO Scott Whitaker said in an emailed statement. “We all share the same goal — an efficient, effective FDA review process that helps advance the m... |
| Jul 24, 2024 | Datavant to Showcase AI Innovations in Clinical Trials at AI Demonstration Day on Capitol Hill | NEW YORK, July 24, 2024 /PRNewswire/ -- Datavant, the leading health data platform company, announced today its upcoming participation in the Artificial Intelligence (AI) Demonstration Day reception on July 25, 2024. This prestigious event,... |
| Mar 21, 2024 | Diagnostic test debate returns with FDA rule near | The VALID Act and the regulation of diagnostic tests resurfaced at a House Energy and Commerce hearing today that coincided with the FDA finalizing a rule that would give it oversight for four years.
The big picture: Trade groups mostly sup... |
| Mar 18, 2024 | E&C revives debate on lab-developed tests | The House Energy and Commerce Committee will meet on Thursday to resume the debate on regulation of lab-developed tests.
Why it matters: The FDA's statutory authority over the tests has been a major friction point and could become the objec... |
| Mar 15, 2024 | New curbs on medical device sterilizer ease fears of shortages | New federal restrictions on a cancer-causing chemical that's essential for sterilizing medical devices may have balanced out long-running concerns about protecting public health without choking the medical supply chain.
But the tradeoffs wo... |
| Feb 2, 2024 | Digital health caucus launches with focus on AI | Lawmakers launched a Digital Health Caucus on Thursday with the goals of educating colleagues, hashing out regulatory challenges and anticipating changes posed by artificial intelligence.
Why it matters: Yet another caucus is hardly breakin... |
| Jan 19, 2024 | NeuroVirt, Thе Greek-founded VR Rehabilitation Software That Hеlps Strokе Survivors Livе Fully | Greece, UK ~
Company:
Only have 1 minute? Here are 3 key takeaways: Despite a 67% increase in overall venture financing in medtech since 2017, investors are cautious about early-stage technologies, according to Delotte’s report. NeuroVirt, ... |
| Dec 26, 2023 | 3 medtech trends to watch in 2024 | It’s been a slow year for medtech. Major deals in 2023 were scarce, funding was hard to come by, and valuations were down. On the policy side, the industry grappled with changing AI regulations, reimbursement woes, and device sterilization ... |
| Apr 11, 2023 | EPA proposes limits on carcinogenic gas used to sterilize medical devices | On Tuesday, the Environmental Protection Agency proposed new limits on the use of a carcinogenic gas called ethylene oxide. The hope is to reduce ethylene oxide emissions by 80%, which the agency said is part of the Biden administration’s C... |
| Apr 11, 2023 | AdvaMed Responds to Proposed Rules Governing Ethylene Oxide's Role in Sterilizing Medtech | Approximately 50% of the Medtech Patients Depend on for Care is Sterilized with Ethylene Oxide
WASHINGTON, April 11, 2023 /PRNewswire/ -- The Environmental Protection Agency (EPA) today released its proposed rule regulating ethylene oxide (... |
| Jun 28, 2022 | Venture Leaders Medtech: 10 Swiss medtech startups showcase cutting-edge innovations in Boston | Venture Leaders Medtech: 10 Swiss medtech startups showcase cutting-edge innovations in Boston 28.06.2022 14:00, Tracy Woodley linkedIn facebook twitter instagram youtube -->
The Venture Leaders— as members of the Swiss National Startup ... |
| May 4, 2022 | Medtech CEOs sound off on semiconductor shortage, pushing Biden administration for prioritization | BD CEO, President and Chair Tom Polen [Photo courtesy of BD]AdvaMed continues to push the Biden administration to prioritize medical device manufacturers for semiconductor supplies.
With medtech companies still struggling to source chips am... |
| Aug 5, 2021 | The chip shortage is getting worse | Starting next week, General Motors is again halting the assembly lines of several pickup truck plants because the company doesn’t have enough computer chips. The plants had been back up and running for just a week following a shutdown in Ju... |
| Aug 3, 2021 | Getinge Joins AdvaMed, Reinforcing Global Commitment to Advancing Innovation in Medical Technology and Improving Healthcare Policy and Patient Outcomes | Getinge Joins AdvaMed, Reinforcing Global Commitment to Advancing Innovation in Medical Technology and Improving Healthcare Policy and Patient Outcomes Tue, Aug 03, 2021 15:00 CET
Wayne, NJ (August 3, 2021) – Getinge today announced that th... |
| Apr 1, 2021 | Digital therapeutics startup Dthera Sciences was sunk by Alzheimer's drug failures, CMS reimbursement limitations | (Photo by Sebastian Kaulitzki/Getty Images) |
| Jul 23, 2018 | A tax on medical devices makes no sense. It’s time to eliminate it for good | Earlier this year, Congress made the wise decision to once again suspend the medical device tax for two years. But this temporary reprieve doesn’t go far enough. To maintain the nation’s vibrant medical technology ecosystem, it’s time to el... |
| May 15, 2017 | AdvaMed unveils new tools to assess medical device value | AdvaMed today launched a new value initiative that includes extensive tables of questions to help medical device companies formulate value-based arguments.
The value framework also includes tools specifically designed for diagnostic technol... |
| Feb 8, 2017 | Medtech lobby says 29,000 jobs were lost while device tax was in effect | Citing data from the U.S. Census Bureau’s Annual Survey of Manufacturers, a medtech industry lobby said that the industry lost nearly 29,000 jobs when the medical device tax was in effect.
AdvaMed, the Washington, D.C. advocacy group said o... |
| Dec 12, 2016 | Bringing the sexy (back) to medtech | It’s a smart move by the medtech association to serve a growing sector within healthcare, one that is now interfacing with the traditional medtech industry to create smart, connected devices. For example, the sexy makeover of the humble blo... |
| Nov 9, 2016 | ACA repeal, CHIP renewal could top Trump’s healthcare agenda | That remains difficult with Democrats still commanding enough power in the Senate to block the 60 votes needed for a full repeal. Republicans could use fast-track budget authority to make some major changes to the law, although that could t... |
| Apr 3, 2015 | Show me the money: Reimbursement for medical innovations | By Nancy Fliesler
Device developers tend to focus on the FDA approval process – PMAs and 510(k) clearances – while overlooking another major challenge: getting insurers to cover the device. Before approaching investors, and certainly before... |
| Mar 12, 2015 | 3 Ways Obamacare Is Impacting Medical Tech Hiring | Although the impact of the tax is still unclear, here are some potential effects Obamacare will have on hiring in medical technology:
Recruiting On the Dime
In the wake of the excise tax, corporate recruiters may turn to less expensive hiri... |
| Feb 25, 2015 | Bill to protect FDA user fees introduced in the U.S. House of Representatives | Industry trade association AdvaMed said Wednesday it applauds a bill introduced into the U.S. House of Representatives that would protect FDA user fees from sequestering cuts.
The bill was introduced by Rep. Leonard Lance (R-N.J.) and Rep. ... |
| Jan 27, 2015 | Welcome to Warsaw, Indiana. Does the industry’s medical-device tax story reflect reality on the ground? | Till’s bullish view of the medical device industry – he says he can’t crank out graduates fast enough — contrasts sharply with what industry lobbyists are telling lawmakers in the nation’s capital. They say a 2.3 percent tax on the sale of ... |
| Nov 11, 2014 | AdvaMed opens Shanghai office | AdvaMed yesterday said it officially opened its Shanghai office during a ceremony in Beijing.
The Shanghai outpost, 1st recognized by Chinese authorities last May, builds on groundwork laid during 2 years’ work in China by Lynn Jiao, execut... |
| Oct 7, 2014 | AdvaMed in the age of consolidation | The winds of change in medtech are blowing in the Windy City.
As medtech’s best & brightest descended on Chicago for another annual confab at AdvaMed 2014, it was impossible to ignore that the industry has now entered the great age of c... |
| Aug 8, 2014 | Despite excise tax, Medtech jobs steady and even rising – but it’s still gonna be a bumpy ride | A Forbes op-ed cites the report as rationale for why those clamoring for a repeal of the tax need a new argument, since stifling job growth certainly isn’t one of them. The medical device excise tax, enacted as a revenue-generating portion ... |
| Jul 22, 2014 | Medtech saves the U.S. billions in chronic care, industry study says | MassDevice.com On Call | MASSDEVICE ON CALL — The medical device industry has been a target for years for researchers and critics who have claimed the industry is a prime contributor to the skyrocketing cost of U.S. healthcare, and industry advocates responded this... |
| Jun 17, 2014 | Device makers fight pricing war with new study | Medical device makers have long faced intense pricing pressure from customers and scrutiny from policy-makers, but an ongoing industry study suggests that medtech has for years been a minor factor in the growing cost of U.S. care.
Researche... |
| Jun 3, 2014 | Medtech lobby AdvaMed opens doors in China | Medical technology lobbying group AdvaMed announced this week that it won approval from Chinese authorities to open an office in Shanghai, an important emerging market for many of AdvaMed’s largest member companies.
The lobby hopes to use t... |
| Jun 2, 2014 | Opinion: Medical device tax is cutting jobs, R&D and U.S. investment, survey shows | By Stephen Ubl, president & CEO, AdvaMed
The medical device and diagnostics industry is an American success story, creating life-saving and life-enhancing innovations every day while providing high-quality jobs in communities both large... |
| May 9, 2014 | CareFusion taps Boston Scientific exec Bose for board | Personnel Moves | CareFusion (NYSE:CFN) said it named Supratim Bose, an executive at Boston Scientific (NYSE:BSX) who spent 30 years at Johnson & Johnson (NYSE:JNJ), to its board of directors.
Bose has been president of Asia-Pacific, Middle East and Afri... |
| Mar 20, 2014 | Procured Health gets $4M to find out why an artificial knee can cost $3,500 or $10K | The medical device market is so obtuse that most doctors are completely in the dark about how much it costs to buy a blood pressure monitor or a spinal screw.
A small startup called Procured Health just secured $4 million in series A fundin... |
| Feb 18, 2014 | Report: Medtech tax has cost 33,000 jobs already | The medical device industry has already lost some 33,000 jobs as a result of the medical device tax, according to a report from lobbying group AdvaMed.
Including indirect repercussions in related industries and the economy in general, AdvaM... |
| Feb 11, 2014 | Q & A: Collaboration between physicians and medical technology companies crucial | by Chris White and Diane Biagianti
Partners for Healthy Dialogues partner Christopher White (general counsel, AdvaMed) recently sat down with Diane Biagianti, vice president, chief responsibility officer, Edwards Lifesciences, to talk about... |
| Feb 4, 2014 | When do you need a registry? AdvaMed’s new threshold questions | Registries are an increasingly popular tool for gathering population-level data on a particular medical device or therapy, but given their complex nature and potentially high cost they may not be the best way to get the information needed.
... |
| Jan 15, 2014 | AdvaMed lauds user fee return, new funding for FDA | MassDevice.com On Call | MASSDEVICE ON CALL — Medtech industry lobbying group AdvaMed offered high praise for the federal government’s 2014 omnibus appropriations legislation, which restored important funding for the FDA.
The bill returned to the agency about $85 m... |
| Nov 27, 2013 | Understanding interactions between physicians and biopharmaceutical and medical technology professionals | As the Centers for Medicare and Medicaid Services (CMS) works to develop a searchable public website for reported “transfers of value” from health industry manufacturers to physicians and teaching hospitals, as required under the 2010 physi... |
| Nov 19, 2013 | When medical content providers go political | By Westby G. Fisher, MD, FACC
It is an interesting time in medicine.
If we step back a few thousand feet and look down on America’s medical world, we see a mess. We see rules and regulations run amok. We see doctors under unprecedented pres... |
| Oct 28, 2013 | AdvaMed study: Medical devices are part of the solution, not the problem | Medical devices are not the cause of price variations in hospital care across the U.S., but rather are a part of the solution, according to medical device industry lobbying group AdvaMed.
“It is really clear in the evidence provided by thes... |
| Oct 28, 2013 | Feds say physician-owned distributors increase spine surgery costs | The cost of spinal fusion surgeries is boosted when hospitals purchase medical devices from physician-owned distributors, according to Daniel Levinson, the inspector general of the U.S Health & Human Services Dept.
The POD businesses al... |
| Oct 14, 2013 | FAQ: Repealing the medical device tax | Q: What is the medical device tax?
A: Since the beginning of this year, medical device manufacturers and importers have paid a 2.3 percent tax on the sale of any taxable medical device. The tax applies to devices like artificial hips or pac... |
| Sep 23, 2013 | Report: Prices drop for major medical implants | Updated September 23, 2013, at 6:45 p.m. with comments from AdvaMed chairman David Dvorak.
Hospitals in 2011 paid an average of 34% less for drug-eluting stents than they did in 2007, according to a new report. They also paid 27% less for b... |
| Sep 20, 2013 | FDA’s new Unique Device Identifier rule addresses some, not all, industry concerns | Updated September 20, 2013, at 3:30 p.m. with comments from the Medical Device Manufacturers Assn.
The FDA’s updated labeling standard, including product and manufacturer name, expiration date, reference and lot no., bar code and details.
T... |
| Jul 17, 2013 | Small, medium or large, businesses want the medical device tax to go | Which could prove to be a devastating blow to the Hoosier economy. COOK is headquartered in Indiana, a state that has almost 20,000 medtech jobs, according to AdvaMed.
There, Sen. Joe Donnelly (D) and Sen. Dan Coats (R) have been “extremely... |
| Jun 12, 2013 | AdvaMed on the 510(k): Leave well enough alone | The FDA’s proposal to enhance regulatory oversight of modifications made to already-cleared devices ruffled some feathers among the medtech industry, which warned that more rigid oversight could triple the agency’s work without conferring m... |
| Apr 18, 2013 | Kinetic Concepts CEO named interim head of sister company LifeCell | Personnel Moves | Kinetic Concepts CEO named interim head of sister company LifeCell
Kinetic Concepts president & CEO Joseph Woody was named interim CEO of LifeCell Corp. after ex-CEO Lisa Colleran’s departure to "pursue new opportunities."
Col... |
| Feb 28, 2013 | Device lobby “doubles down” on medical device tax repeal | MassDevice.com On Call | MASSDEVICE ON CALL — Medical device lobbying group AdvaMed unveiled its 2013 agenda, highlighting its efforts to "double down" on efforts to repeal the 2.3% medical device tax that took effect at the start of the year.
"This ... |
| Feb 1, 2013 | More competitive bidding compromises patient access, device makers say | Medical device industry lobbying group AdvaMed spoke out against an expansion to Medicare’s competitive bidding programs, warning that the changes may deprive patients of their preferred devices.
Some analysts have lauded the Centers for Me... |
| Dec 18, 2012 | Device makers need many months, millions of dollars to figure out medtech tax compliance | Medical device industry lobbying groups warned that the tax slated to take effect on January 1 will cost the industry more than the $30 billion it’s slated to raise over 10 years – it could cost upwards of $660 million annually in implement... |
| Nov 14, 2012 | Lobby group ups ante on device tax repeal by taking 50 execs to talk with lawmakers | They include executives from C.R. Bard, Stryker, Cook Medical, but it appears that big name firms like Medtronic decided not to participate.
On Wednesday, AdvaMed also published a new report that shows that the device industry’s tax hill wi... |
| Nov 13, 2012 | Lobbying group pushes back against notion that medical devices increase health costs | The report released at the end of October comes a couple of months after another study published in Health Services Research painted a completely different picture of medical devices and their contribution to health costs. The lead authors ... |
| Nov 9, 2012 | It’s All About the Ground Game: Election Lesson for Emerging Med-Techs | Build a diverse grassroots coalition
When creating a base of supporters, it is tempting to go exclusively for the “money” targets, in politics the rich and famous and in med-tech the mighty “KOLs” who are editors of this and past-presidents... |
| Oct 24, 2012 | Report: Medtech spending, pricing barely budged in more than 20 years | Click to enlarge graph.
Medical devices are often at the center of healthcare spending debates, but a new report released by medical device industry lobbying group AdvaMed concluded that "medical devices are a relatively small and very... |
| Sep 19, 2012 | AdvaMed names John Graham VP of payment & healthcare policy | Personnel Moves | AdvaMed names new research & policy VP
Medical device industry lobbying group AdvaMed named John Graham its new vice president of payment and health care delivery research & policy.
Graham is currently also an adjunct scholar at the... |
| Jul 19, 2012 | The Affordable Care Act: Implications for Emerging Med Tech Companies | Primary care services are slated for increased reimbursement and bonuses under the ACA, not that a lot of expensive devices are used in this setting. Wouldn’t be a stretch to imagine an increase in routine point of care testing with the enc... |
| Jul 11, 2012 | Med-Tech CEOs turn passion into mission with boot camp for vets | It’s not surprising that Abiomed (NSDQ:ABMD) CEO Michael Minogue supports the troops. After all, the West Point grad is a former airborne infantry platoon leader and a Desert Storm veteran.
It is, however, a little surprising just how much ... |
| Jun 29, 2012 | Reaction to U.S. Supreme Court ruling: Medical device leaders | “We began planning for implementation of the measures in the Affordable Care Act long ago. We have been engaged in payment and delivery system reform changes that started before passage of the ACA in the private sector and that will continu... |
| May 24, 2012 | The Mythical Emerging Medical Device “Platform” Company | What do unicorns, fairies and medical device platform plays all have in common? They would be delightful to see, but sadly don’t exist. “Wait a minute,” you say, “My incredible new medical technology has so many potential applications that ... |
| Apr 19, 2012 | AdvaMed unveils new 3-year plan | The Advanced Medical Technology Assn. today unveiled a new 3-year, 3-prong strategy for overcoming the "significant regulatory and economic challenges facing the industry."
New AdvaMed chairman and Zimmer (NYSE:ZMH) president &... |
| Mar 27, 2012 | “We are poised to dominate this field:” Sen. Toomey on biotech; PA, MN Congressmen want new medical device tax repealed [VIDEO] | As if the Obama Administration’s healthcare bill —The Affordable Care Act — wasn’t under enough fire this week with the start of Supreme Court hearings yesterday, medical technology trade organization AdvaMed held a press conference with co... |
| Feb 7, 2012 | AdvaMed: Repealing the med-tech levy is about tax reform, not health care reform | AdvaMed’s president & CEO Stephen Ubl and chairman James Mazzo.
AdvaMed officials today released a set of principles for modifying the U.S. tax system, part of the group’s efforts to gain Democratic support for repealing the impending 2... |
| Feb 2, 2012 | FDA’s medical device user fees to double. Is the FDA asking too much? | Under a preliminary deal announced Wednesday, medical device user fees paid to the U.S. Food and Drug Administration are going to more than double in the next five years.
That might not sit well with some medical device makers who have long... |
| Feb 1, 2012 | Medical device user fees will be $595M as part of preliminary deal with FDA | Now, a tentative deal has been reached. The FDA announced Wednesday that in exchange for agreeing to shorter review periods for 510(k) applications and other performance improvements, the FDA is getting $595 million over five years from the... |
| Feb 1, 2012 | FLASH: Device makers agree to double user fees | The medical device industry and the FDA came to a tentative agreement on reauthorizing the Medical Device User Fee & Modernization Act – for double the price.
Although negotiations seemed stagnant and the agency quietly missed its Jan. ... |
| Jan 20, 2012 | 10 arrested in 2 cases of Medicare fraud | MassDevice.com On Call | MASSDEVICE ON CALL — A federal grand jury indicted 10 individuals related to 2 schemes to defraud Medicare that cost the health care program more than $2 million in false claims for durable medical equipment.
Husband and wife Gilberto Gómez... |
| Oct 31, 2011 | Med-tech lobby AdvaMed approves construction plans for charity clinics in China | MassDevice.com On Call | MASSDEVICE ON CALL — Medical device industry lobby AdvaMed’s construction plans were approved by its Hope Fund management committee, making progress on plans to build clinics for under-served populations in China.
AdvaMed plans to build two... |
| Oct 12, 2011 | Whistleblowing doctor fired from Northwestern University | Personnel Moves | A Northwestern University cardiologist who sparked a federal investigation into a fellow physician for alleged misconduct was fired after being denied tenure.
Dr. Nalini Rajamannan, who was an associate professor of medicine at the universi... |
| Sep 7, 2011 | Medical device tax could kill 11 percent of U.S. med-tech jobs, AdvaMed says | Medical device industry lobby AdvaMed says that the new 2.3 percent excise tax, slated to go into effect in 2013, will be “the last straw on the camel’s back” for medical device companies trying to thrive in the struggling American economy.... |
| Aug 29, 2011 | Deficit: Cut medical devices to curb health care spending, Harvard researchers say | Health care spending could be curbed by doctors cutting back on expensive medical devices rather than slashing Medicare and Medicaid, according to Harvard researchers.
Speaking in advance of next month’s Congressional supercommittee meeting... |
| Aug 26, 2011 | Med-tech trade group spends $336,000 lobbying Congress in Q2 | The Advanced Medical Technology Assn. or AdvaMed spent more than $366,000 during the second quarter and $417,000 so far this year to lobby Congress in favor of the medical device industry.
Q2 spending represents a 4 percent dip from the sam... |
| Jul 15, 2011 | AdvaMed: Medical device prices and spending stagnant over 20 years | “It’s important for policymakers to understand that patient access to medical technology saves lives and improves quality of care. Medical devices and diagnostics are central to medical practice, but spending on advanced medical technology ... |
| Jul 14, 2011 | Medical device prices have barely budged in 20 years, says med-tech lobby | Medical device spending vs. national health expenditures
1989-2009
As Congress considers cuts in health care spending and the FDA prepares to reauthorize users fees for medical devices, industry lobby AdvaMed issued a report finding that na... |
| Jun 15, 2011 | Med-tech CEOs storm Capitol Hill | The Medical device industry is stepping up the pressure on congress in its call for a more consistent regulatory environment at the FDA.
The Advanced Medical Technology Association, or AdvaMed, flew 20 medical device CEO’s into Washington t... |
| Jun 11, 2011 | Should the medical device industry rethink its political donation strategy? | Like most industries, the medical device industry loves to complain about its government regulators.
The U.S. Food & Drug Administration’s regulatory process is too slow, too inconsistent and too fraught with uncertainty, which in turn ... |
| Jun 10, 2011 | Should the medical device industry rethink its political donation strategy? | Even Dr. Jeffrey Shuren, director of the FDA’s device-regulating group, the Center for Devices & Radiological Health (CDRH), agrees that turnover within his group is too high.
“It’s critical that we reduce the unacceptably high staff tu... |
| Jun 6, 2011 | Medical device industry to White House: Special office for medical innovation, please | The medical device industry’s Washington lobby called for the creation of a special government office with oversight of “major proposed and current government policies to assure that they support medical innovation.”
The Advanced Medical Te... |
| May 16, 2011 | Siemens taps Harvard prof to replace interim health care CEO | Personnel Moves | Here are the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more recent hirings and firings, check out MassDevice’s compilation of the latest personnel moves.
Siemens taps Harvard... |
| Mar 22, 2011 | Bovie Medical names new president, shuffles board | Personnel moves | Bovie Medical Corp. (NYSE:BVX) announced a flurry of personnel moves in its corner office and board room.
The company said current president and CEO Andrew Makrides will relinquish his title of president but keep his position as chief execu... |
| Mar 1, 2011 | AdvaMed taps Tharini Sathiamoorthy for diagnostics post | Personnel moves | Advanced Medical Technology Assn. hired veteran policy analyst Tharini Sathiamoorthy for a top spot in its diagnostics division.
The Washington, D.C.-based medical device industry council tapped Sathiamoorthy to be associate vice president ... |
| Feb 22, 2011 | Top device VC: Fix FDA or watch business go to Costa Rica | A Boston, Mass.-based venture capitalist and former Boston Scientific Corp. (NYSE:BSX) executive is adding his voice to the chorus of medical device stakeholders calling for an overhaul to the way the FDA regulates medical devices.
In a col... |
| Feb 22, 2011 | FDA regulations will send medical device companies out of US, VC warns | LaViolette is no stranger to the device market or to the FDA’s Center for Devices & Radiological Health. He spent 15 years at the Natick, Mass.-based device giant, with stops as president of the cardiology and international groups. His ... |
| Jan 28, 2011 | Study: European regulatory regime just as safe as FDA’s | The medical device industry is touting a study it says debunks the Food & Drug Administration’s claims that there’s a safety benefit from the slower, more rigorous regulatory process in the U.S.
The conclusions are based on a new study,... |
| Jan 28, 2011 | Does Europe offer faster, better approach than FDA on medical devices? | Promoted
This Patient Experience Checklist Is Your Key To Success in 2021
As healthcare systems strive to recover from losses due to the pandemic, patient acquisition and retention have never been more urgent, and patient experience has nev... |
| Jan 19, 2011 | New FDA 510(k) medical device reviews will now be ‘smarter’ | On some of the tough decisions, the FDA essentially punted, asking the Institutes of Medicine (IOM) to study the corresponding proposals further. The Wall Street Journal called the move to table some proposals a concession to the device ind... |
| Dec 18, 2010 | Personnel moves: Pulmatrix taps Eva Jack as chief business officer | Pulmatrix taps Eva Jack as chief business officer
Pulmatrix announced the appointment of Eva Jack as chief business officer. In this newly created position, Ms. Jack will provide strategic leadership as the Company begins business developme... |
| Dec 1, 2010 | UPDATE: CDRH chief Shuren blasts Stanford study on medical device regulations | Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearin... |
| Nov 19, 2010 | Medical device makers spend millions to meet FDA rules, study finds | The report (PDF) states that the average cost to bring a low-to-moderate 510(k) product from concept to market is $31 million. More than 77 percent of that, $24 million, was spent on FDA-dependent or related activities. High-risk PMA costs ... |
| Nov 18, 2010 | Study: FDA-related activities cost $24 million per 510(k) | More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report.
The report, “FDA Impact on U.S. Medical Technology Innovation,” ... |
| Nov 11, 2010 | AdvaMed appeals for accelerated device approval in Japan | The Advanced Medical Technology Assn. recently returned from a trip to Japan where they pushed for a faster medical device approval process.
AdvaMed, which represents the device industry, said its member companies are "increasingly pas... |
| Sep 15, 2010 | AdvaMed: The 510(k) program is just fine as is | The Advanced Medical Technology Assn. released a study of the safety records of medical devices cleared for the market via the Food & Drug Administration’s 510(k) process.
AdvaMed, which represents the device industry, said its analysis... |
| Sep 15, 2010 | 510(k) A-OK? Study calls medical-device approvals safe | The Advanced Medical Technology Assn. released a study of the safety records of medical devices cleared for the market via the Food & Drug Administration’s 510(k) process.
AdvaMed, which represents the device industry, said its analysis... |
| Aug 12, 2010 | Stryker CEO tapped for federal Manufacturing Council | U.S. Secretary of Commerce Gary Locke tapped Stryker Corp. (NYSE:SYK) CEO Stephen MacMillan for the 2010 Manufacturing Council.
MacMillan will serve as the medical device and diagnostics industry’s representative on the 25-member federally ... |
| Jun 9, 2010 | Report: Med-tech industry outpaces U.S. economy | A new report from the Advanced Medical Technology Assn. touts the medical technology industry’s fortitude through the recession.
The 28-page account, "The State Economic Impact of the Medical Technology Industry," considers the se... |
| Jan 22, 2010 | BioOhio, LifeScience Alley ask legislators to limit medical device sales tax | Medical device makers learned about the proposed taxes in September when the Senate Finance Committee floated an early version of its health reform bill, which included an annual fee, based on market share, aimed at raising $4 billion a ye... |
