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

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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

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

Dexcom posts 53% US revenue growth in 'blowout' Q3

Demand for continuous glucose monitors is set to help the medtech achieve its first year of profitability, but a manufacturing lapse could ​slow some patient transitions to its most up-to-date technology.

By Maria Rachal • Nov. 7, 2019

After stumble, diabetes drives Livongo to top Q3 estimates

A triple-digit jump in diabetes members helped the digital health firm beat and raise expectations.

By Nick Paul Taylor • Nov. 7, 2019

Hologic beats sales outlook on diagnostics, breast health

The women's health-focused company said it's planning to fuel further growth with more tuck-in acquisitions. But analysts gave a muted response to the results and shares were down 5% Thursday morning. 

By Nick Paul Taylor • Nov. 7, 2019

FDA pitched progressive device pathway to Warren and Murray, reversing Gottlieb

The former FDA chief told lawmakers last year that such a framework would not be suitable for human products, but now the agency says it could speed devices for children.

By David Lim • Nov. 6, 2019

Europe allows Edwards' Sapien 3 TAVR system in low-risk patients

After winning low-risk approval in the U.S. alongside Medtronic, Edwards Lifesciences said it is the first manufacturer to receive the indication in Europe.

By Maria Rachal • Nov. 6, 2019

Tandem awaits FDA's Control-IQ nod, Insulet puts finishing touches on Horizon

Insulin pump maker earnings calls teased significant upcoming events, with approval of Tandem's automated dosing algorithm seen as imminent and Insulet readying a pivotal trial of its hybrid closed loop system.

By Maria Rachal • Nov. 6, 2019

Medtronic, Boston issue paclitaxel data in rebuff to safety worries

Manufacturers are on defense after a meta-analysis raised safety questions about use of the coated devices for peripheral artery disease.

By Susan Kelly • Nov. 6, 2019

Medtronic sues Axonics in patent battle for sacral neuromodulation market

Axonics' new system to treat fecal incontinence, which began a commercial launch this quarter, is challenging Medtronic's dominant InterStim product line.

By Dana Elfin • Nov. 6, 2019

7 questions about ethylene oxide as FDA panel convenes

Agency advisers are meeting again Thursday, having already encouraged FDA to incentivize lower industry reliance on EtO, while acknowledging state regulators' potential to strain sterilization capacity and create device shortages.

By David Lim • Updated Nov. 7, 2019

2 more notified bodies win EU MDR nod, bumping industry tally to 7

BSI Group said Wednesday its operation in the Netherlands is now designated under the European Medical Device Regulation, a day after DARE!! Services B.V. became the first in the country to be certified.

By Maria Rachal • Updated Nov. 6, 2019