Medical Devices: Page 171
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Stryker settles foreign corrupt practice charges, makes small acquisition
The company will pay $7.8 million to settle with the Justice Department. Separately, the medical device maker said it would acquire HyperBranch Medical Technology.
By Susan Kelly • Oct. 2, 2018 -
FDA, ECRI, device group keep up drumbeat on cybersecurity risks
The agency is launching a cybersecurity playbook for healthcare providers and said it will publish a "significant update" to its 2014 premarket guidance.
By Susan Kelly • Oct. 2, 2018 -
Explore the Trendlineâž”
Sitthiphong via Getty Images
TrendlineMedical 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 -
5 themes from The MedTech Conference
Mergers and acquisitions, digital health, FDA pilot programs and Netflix's The Bleeding Edge were among the hot topics in Philadelphia.
By David Lim , Kim Dixon • Oct. 1, 2018 -
FDA exploring potential for IMDRF Medical Device Single Review Program
The idea is for the marketing authorization for a medical device by one country to be relied on in part or in whole by other participating jurisdictions, according to FDA device chief Jeff Shuren.
By David Lim • Oct. 1, 2018 -
Ready or not, medtech braces for new EU landscape
Companies should not assume they'll get extra time to adapt, warned Vicki Anastasi, VP for medical device and diagnostics research at ICON.
By Kim Dixon • Oct. 1, 2018 -
AngioDynamics posts bigger net loss, looks to oncology
Executives said the company's two recent acquisitions signal a shift in investment to the oncology section of the business.
By Tyler Woods • Oct. 1, 2018 -
FDA finds fault with some insulin pen use directions
The agency is asking manufacturers to review their directions for use and training materials and consider adding a label warning about the need to remove both the outer and inner needle covers.
By Susan Kelly • Oct. 1, 2018 -
Doctor survey finds strong interest in new urology devices
Jefferies analysts polled 50 high-volume urologists and reported Teleflex's UroLift device accounted for 15% of procedures for an enlarged prostate while Boston Scientific's Rezum was used in 10%.
By Susan Kelly • Oct. 1, 2018 -
Hologic acquires developer of breast cancer surgery marker
The company agreed to pay $125 million for Focal Therapeutics, the latest addition to its breast health product portfolio, two months after purchasing digital imaging systems maker Faxitron Bioptics in an $85 million deal.
By Susan Kelly • Sept. 28, 2018 -
Butterfly raises $250M in bid to upend ultrasound market
The goal is to replace large, cart-based ultrasound devices that cost tens of thousands of dollars and upend a sector dominated by the likes of GE Healthcare, Philips and Fujifilm.
By Nick Paul Taylor • Sept. 28, 2018 -
New IMDRF committee to tackle cybersecurity threats
The FDA device chief laid out takeaways from the group's Beijing meeting.
By Kim Dixon • Sept. 27, 2018 -
FDA reopens comments on decade-old stent guidance
It comes days after physicians writing in The Lancet used data from a head-to-head comparison of Medtronic's Resolute Onyx and Biotronik's ultra-thin-strut stent Orsiro to highlight the limitations of noninferiority clinical trial designs.
By Nick Paul Taylor • Sept. 27, 2018 -
FDA reclassifies female condoms to reduce regulatory burden
The products will be categorized as Class II devices eligible for the 510(k) pathway.
By Nick Paul Taylor • Sept. 27, 2018 -
FDA expands use of Baxter bone graft to spinal fusion
Rivals Medtronic, Johnson & Johnson, Stryker and Zimmer are all competing for the bone graft substitute piece of the advanced surgery market.
By Nick Paul Taylor • Sept. 27, 2018 -
Global device industry set to grow 5.6% a year through 2024: report
In vitro diagnostics is projected to remain as the No. 1 specialty in 2024 with annual sales of $79.6 billion and a 13.4% share of the medical device industry.
By Susan Kelly • Sept. 26, 2018 -
Medtronic launches Infinity spine fusion system
The company's product launch comes on the heels of its $1.64 billion acquisition of Mazor Robotics.
By Susan Kelly • Sept. 26, 2018 -
FDA's Patel touts promise of software precertification program
Despite concern from the Clinical Decision Support Coalition​ that FDA may not have the legal ability to launch the pilot, the agency says it will work through its current authorities.
By David Lim • Sept. 26, 2018 -
Venus to buy Keystone, moving into Boston Sci's TAVR turf
The move furthers Venus' aspirations to grow into a global transcatheter heart valve company and, by extension, advance China's bid to supercede the U.S. as the dominant medtech force.
By Nick Paul Taylor • Sept. 26, 2018 -
Industry lobbying CMS for speedy Medicare coverage of breakthrough devices
The Center for Medicare and Medicaid Innovation may launch a demonstration project to examine how to balance speeding devices to Medicare patients with the cost implications.
By David Lim • Sept. 25, 2018 -
Medtech companies race to adapt amid vertical integration, new tech threats
The industry is increasingly sharing the risk with payers as a way to prove product value.
By Kim Dixon • Sept. 25, 2018 -
AdvaMed chief: Success in warding off tariffs, but impact rising
While medical devices aren't explicitly on the most recent list of tariffs, the list likely includes component parts used by members of the industry.
By Kim Dixon • Sept. 25, 2018 -
Medtronic CoreValve proves durable in longer-term data
Severe hemodynamic structural valve deterioration was 0.8% for CoreValve versus 1.8% for surgery across five years, with similar rates of mortality and major stroke in both patient samples.
By Susan Kelly • Sept. 25, 2018 -
FDA gives final guidance on device benefits, risks in 510(k) submissions
The recommendations will help in determining substantial equivalence for devices with different characteristics that don't raise new questions of safety and effectiveness, the FDA said.
By Susan Kelly • Sept. 25, 2018 -
FDA approves Cook PAD stent as competition heats up
The approval comes shortly after Boston Scientific received clearance to sell a rival device.
By Nick Paul Taylor • Sept. 25, 2018 -
EY warns stagnant R&D, data use threatens medtech growth
Medtech R&D investment of $15.9 billion remained "relatively unchanged" in 2017 — roughly $1 billion less than the $16.4 billion companies gave back to investors through share buybacks and dividends.
By David Lim • Sept. 24, 2018
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