Medical Devices: Page 135
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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 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
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
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