Medical Devices: Page 139
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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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
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 -
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 -
Courtesy of Edwards Lifesciences
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 -
Paclitaxel, foreign exchange among drags on BD's Q4
Still, executives are optimistic about integration of the 2017 acquisition of Bard, set to deliver $100 million in projected fiscal 2020 savings.
By David Lim • Nov. 5, 2019 -
Hips and knees help Zimmer beat Wall Street amid growing Stryker rivalry
The orthopaedics giant's third-quarter sales growth topped 2% for just the third time in the past three years, with analysts at Stifel concluding the "multi-year turnaround is well on track, if not ahead of schedule."
By Maria Rachal • Updated Nov. 5, 2019 -
As Essure implant return deadline nears, FDA study enrollment inches up
The birth control device, which Bayer stopped selling in December 2018, has been linked to nearly 33,000 reports of adverse events, including 49 deaths.
By Susan Kelly • Nov. 5, 2019 -
Abbott circulatory support system Class I recall linked to 1 death
A calibration system error resulting from electromagnetic interference may cause the pump to slow or stop and the console screen to blank.
By Dana Elfin • Nov. 4, 2019 -
5 breakthrough devices qualify under finalized faster outpatient payment path
CMS said Medicare spending on the five approved devices, which do not need to meet substantial clinical improvement requirements to qualify for the pass-through payments, will be about $116 million in 2020.
By Susan Kelly • Nov. 4, 2019 -
Stryker goes to extrem(iti)es in $4B Wright Medical takeout
Worth $5.4 billion including debt, the deal dwarfs the K2M buyout and sent shares in extremities device maker Wright Medical soaring almost 30%.
By Maria Rachal • Updated Nov. 4, 2019 -
Device aimed at curbing 'dead-in-bed' opioid effects wins FDA breakthrough status
The physician-owned startup Med-botics licensed the patented method from Oregon Health Science University, and changed the technology to be worn on the wrist. The system originally needed to be wheeled on a cart.
By Dana Elfin • Nov. 1, 2019 -
New tech add-on payment for innovative dialysis products final in ESRD, DME rule
Following criticism from industry, CMS did not go through with a plan to use technology assessments to determine comparableness to older items to help establish fee schedule amounts for durable medical equipment.
By David Lim • Nov. 1, 2019 -
Medtronic thoracic stent graft system approved in Japan
The device addresses common attributes and conditions in the Japanese patient population such as greater aortic fragility, smaller anatomy and aortic wall stress, the director of the Japanese Society for Vascular Surgery said.
By Nick Paul Taylor • Nov. 1, 2019 -
Teleflex raises outlook despite taking $8.7M hit tied to sterilization facility closure
CEO Liam Kelly told analysts its sterilization provider has yet to get a "clear line of sight as to when that facility may be reactivated."
By Nick Paul Taylor • Nov. 1, 2019 -
Warren, Murray, Smith redouble scrutiny of FDA over Pre-Cert safety, authority
FDA maintains it has the statutory authority to conduct the software Pre-Cert pilot, but acknowledged it will need help from Congress to update what it calls a 40-year-old regulatory paradigm for 21st century technologies.
By David Lim • Oct. 31, 2019 -
Abiomed targets 'TAVR-like' adoption for protected PCI
Investors appear optimistic about the company's strategy, with its stock up more than 10% in morning trading despite the specter of FDA's questions about survival outcomes with Abiomed's right heart pump in February.
By Maria Rachal • Oct. 31, 2019 -
Smith & Nephew ups outlook a day before new CEO takes helm
Sales of sports medicine joint repair products rose 12.2%, the biggest jump yet in a year that's seen growth of at least 11% each quarter.
By Nick Paul Taylor • Oct. 31, 2019 -
FDA puts J&J's Ethicon surgical stapler recall in top risk category
Ethicon had learned of seven serious injuries and one death related to the recalled products by the time it began pulling the devices from the market.
By Nick Paul Taylor • Oct. 31, 2019 -
Mako momentum lifts Stryker results amid core spine drag
Despite new competition from Zimmer Biomet's total knee application for Rosa, one Stryker exec called pricing for the Mako joint replacement robot "extremely stable" as the company expects 2019 organic sales growth near 8%.
By Maria Rachal • Oct. 30, 2019
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