Medical Devices: Page 145
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FDA flags 2 more deaths, over 60 device failures tied to heart balloon pump
As a software upgrade is in the works for Getinge's Maquet/Datascope ​intra-aortic balloon pump devices, FDA is still trying to determine what is causing the system to shut down while operating on battery power.
By Susan Kelly • Nov. 20, 2019 -
Hologic unloads underperforming Cynosure medical aesthetics unit
"This divestiture was a long time coming and puts an end to a bad marriage," William Blair analyst Brian Weinstein said of Hologic's $1.6 billion deal in 2017. Now, the company expects $138 million in cash proceeds from its sale.
By Dana Elfin • Updated Dec. 30, 2019 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Asian private equity group to buy Lumenis in $1B deal
The maker of minimally invasive devices used in aesthetic procedures competes with rivals like Candela Medical.
By Nick Paul Taylor • Nov. 20, 2019 -
Jacob Bell/MedTech Dive
FDA approves 1st contact lens to slow myopia in children
Concentric rings in the lens focus light in front of the retina in a process that is thought to reduce the stimulus that causes myopia to advance.
By Susan Kelly • Nov. 19, 2019 -
Incoming Medtronic CEO to prioritize 'aggressive' tuck-in M&A, 'reinvigorating' diabetes unit
Growth accelerated for Medtronic in its recent quarter but competitive pressures in areas like arrhythmia management and diabetes had president and future CEO Geoff Martha pledging to "get back to share-taking mode."
By Maria Rachal • Nov. 19, 2019 -
AdvaMed wants FDA to define 'significantly' improved for Safer Technologies Program eligibility
Although the trade association said it supports efforts to speed safer medical devices to market, it believes the agency's draft guidance lacks the specificity needed for industry to understand which devices would be eligible.
By David Lim • Nov. 19, 2019 -
Edwards has edge over Medtronic in TAVR registry studies
The data presented at the American Heart Association meeting favor Edwards' Sapien valve, but confounding factors may explain the differences. Large, randomized trails are needed to generate more evidence, cardiologists said.
By Nick Paul Taylor • Nov. 19, 2019 -
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 -
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
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