Medical Devices: Page 138
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FDA clears Pentax duodenoscope with disposable part in bid to cut infection risk
Center for Devices and Radiological Health Director Jeff Shuren called the clearance "another major step toward lowering the risk of infection among patients," and said duodenoscope safety is a top priority for the agency.
By David Lim • Nov. 18, 2019 -
Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations
A manufacturing problem resulting in damage to the inner lining of the sheath in fewer than 1% of devices prompted the recall. No adverse events were linked to the issue.
By Susan Kelly • Nov. 18, 2019 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Qiagen in talks with potential buyers amid weak results, restructuring
The molecular test maker confirmed Friday it has received several non-binding indications of interest, days after Bloomberg reported Thermo Fisher was eyeing a takeout of Qiagen.
By Susan Kelly • Nov. 18, 2019 -
In stents v. statin debate, analysts call potential impact of ISCHEMIA trial overhyped
The study seemed to favor a conservative approach to treating stable heart disease. But many sell-side analysts called results expected, predicting they won't meaningfully hurt sales for device makers like Boston Scientific.
By Maria Rachal • Nov. 18, 2019 -
Abiomed's Impella may be associated with higher costs, more adverse events than balloon therapy, studies find
"In the long term, who knows how this will play out?" Jefferies analyst Raj Denhoy told MedTech Dive Monday morning amid a 10% drop in its share price. "In terms of the stock, it isn't great."
By Dana Elfin • Nov. 18, 2019 -
Titan Medical puts robot system on hold amid cash crisis
CEO David McNally blamed the move on "inhospitable conditions in the equity capital markets," pledging the company will continue to attempt to secure financing.
By David Lim • Nov. 15, 2019 -
FDA advisers: Metal implants need beefed up ingredient labels
Industry representative Whitney Christian, a toxicologist at Medtronic, told the panel that medical device manufacturers support patients' and doctors' "right to know" what's in implants and are willing to work with FDA on the issue.
By Maria Rachal • Nov. 15, 2019 -
BioSig targets 9 installations of cardiac technology in 2020
BioSig expects the rollout of PURE EP next year to generate its first revenues, allowing it to grow its sales team and enter Europe in 2021.
By Nick Paul Taylor • Nov. 15, 2019 -
Feds sue South Dakota surgeon, distributorships over alleged spinal implant kickbacks
The suit comes amid a backdrop of growing fraud concerns related to physician-owned entities providing medical products to doctors.
By Dana Elfin • Nov. 14, 2019 -
Axonics wins PMA for urinary indication in sacral neuromod, potentially tripling market
The latest approval for overactive bladder positions the medtech to challenge Medtronic for dominance in the sacral neuromodulation market. Shares rose 16% in late morning trading.
By Dana Elfin • Nov. 14, 2019 -
FDA overhauls export certificate guidance after negative feedback
AdvaMed said the draft suffered "from inaccuracies and omissions that FDA must correct." The final guidance provides more information on the appeals process and grounds for denials.
By Nick Paul Taylor • Nov. 14, 2019 -
FDA experts weigh evidence on patients' adverse reactions to common device metals
Suggestions from speakers at Wednesday's advisory panel included conducting comparative effectiveness studies, bolstering the informed consent process and requiring more stringent adverse event reporting.
By Maria Rachal • Nov. 13, 2019 -
Boston Scientific faces lower reimbursement despite White House lobbying bid
In an Office of Management and Budget meeting days before release of CMS' hospital outpatient payment final rule, execs argued the change would deter doctors from a procedure using a device that could reduce opioid dependence.
By David Lim • Nov. 13, 2019 -
Abbott names Robert Ford new CEO, ending Miles White's 21-year tenure in March
The leadership handoff to Ford, an Abbott insider currently serving as COO, is seen as a continuation of current strategy, with Freestyle Libre, Mitraclip and Alinity driving core growth.
By Dana Elfin • Nov. 13, 2019 -
TransEnterix cuts 18% of staff, doesn't take questions from analysts
The company will focus less on selling robotic surgery systems, newly appointed CEO Anthony Fernando told investors during its third quarter earnings call. Instead, he wants to expand use among existing customers.
By Nick Paul Taylor • Nov. 13, 2019 -
Eudamed 2-year delay doesn't mean free pass for manufacturers
"The Eudamed project is expensive both in time and resources. It is not just an IT project, this is a change project," said Eudamed.eu CEO Richard Houlihan.
By Dana Elfin • Nov. 12, 2019 -
Medtronic's Micra AV pacemaker meets study goals, submitted for FDA review
The company wants to expand the transcatheter pacing system first approved in 2016 to patients with atrioventricular block, a condition marked by impaired electrical signals between the heart's upper and lower chambers.
By Susan Kelly • Nov. 12, 2019 -
Establishment Labs sees 40% rise in breast implant sales, on track for $100M benchmark in 2020
As it awaits U.S. marketing authorization, the Costa Rican medtech is expanding its direct sales force in Europe and Brazil amid a 45% year-to-date decline in Allergan's worldwide breast implant revenues.
By Maria Rachal • Nov. 12, 2019 -
Life Spine, execs settle implants kickback case for nearly $6M
The medtech said it had made significant progress strengthening its compliance program even before it began negotiations with the government.
By Dana Elfin • Nov. 11, 2019 -
Wright Medical growth slowed in run-up to Stryker deal
While Wright's Cartiva big toe treatment dragged on sales for a second straight quarter, Stryker expects the acquisition to bolster its broader extremities business, particularly in shoulder devices.
By Susan Kelly • Nov. 11, 2019 -
Duodenoscope reprocessors' poor work conditions exacerbate infection problem, FDA panel says
The advisory meeting followed FDA disclosing reports of three deaths, 45 patient infections and 159 cases of device contamination related to inadequate device reprocessing between October 2018 and March 2019.
By David Lim • Nov. 8, 2019 -
In latest delay, time extended for experts to apply for MDR, IVDR panels
Industry insiders said low compensation and a stringent conflict of interest policy may have discouraged experts from applying to the panels. Notified bodies must consult with the panels before clearing certain high-risk devices.
By Dana Elfin • Nov. 8, 2019 -
Medtronic reveals high-risk cyber vulnerability in electrosurgical generators
The Department of Homeland Security rated the vulnerability, which could be exploited remotely by a low-skilled hacker, a 9.8 on a 10-point risk scale.
By Nick Paul Taylor • Nov. 8, 2019 -
Deep Dive
Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure'
FDA should consider asking HHS Secretary Alex Azar to declare a public health emergency and override state legislation to get sterilization plants back online, one advisory panel member said.
By David Lim • Nov. 8, 2019 -
Medicare overpays for certain orthotic devices, OIG finds
Medicare and beneficiaries reportedly paid $341.7 million more than other payers for certain orthotic devices, building on prior investigations' findings that CMS has overpaid for services like radiation and sleep studies.
By Nick Paul Taylor • Nov. 7, 2019
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