Medical Devices
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Deep Dive4 main takeaways from HIMSS19
Digest the biggest health IT conference of the year with this roundup of what grabbed the attention of more than 43,000 health execs, policymakers and academics.
By David Lim , Rebecca Pifer • Feb. 15, 2019
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FDA orders doctor to stop marketing unapproved breast augmentation device
The warning letter comes amid increased scrutiny of breast implants by regulators globally, with reported cases of adverse events linked to the devices on the rise.
By Susan Kelly • Feb. 15, 2019
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Boston Scientific-BTG deal faces FTC holdup
The embolization beads businesses are at the heart of U.S. anti-trust regulators' concerns.
By Maria Rachal • Feb. 15, 2019
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HIMSS19: Doctors don't know what to do with data from wearables
"If you present this data and bring in your device and say 'here I have this heart rate data from the last month' we're going to say, 'that's great, but we don't know what it really means,'" a Mayo Clinic medical director said.
By David Lim • Feb. 15, 2019
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HIMSS19: Medical device cybersecurity still top concern
The WannaCry attack highlighted the need for hospitals to have a better understanding of medical devices in their inventory in order to better be equipped to respond to cyberattacks.
By David Lim • Feb. 15, 2019
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New medtech initiatives to be funded amid 9% FDA budget boost
The agency would receive $269 million more in funding this year from the appropriations package that passed Congress, with allocations for initiatives addressing medtech manufacturing and digital health.
By Maria Rachal • Feb. 15, 2019
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Tandem gets FDA OK for first interoperable insulin pump
The pump works with an array of automated insulin dosing systems, continuous glucose monitors and other products. FDA thinks the De Novo clearance will encourage marketing of more connected diabetes devices.
By Nick Paul Taylor • Feb. 15, 2019
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HIMSS19: CMS plans to host AI challenge, innovation chief says
The goal of the initiative is to spur private interest in the tech, improve the government's grasp on healthcare data, eliminate unnecessary care and cut costs, Adam Boehler said.
By Rebecca Pifer • Feb. 14, 2019
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Medical devices recalled from US jump in Q4
The more than 400% surge in recalled units was underpinned by a widespread action by BD.
By Nick Paul Taylor • Feb. 14, 2019
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Software products face high-risk upclassing in Australia
The Therapeutic Goods Administration wants to significantly increase the regulatory burden on medical software, with some products potentially jumping from the lowest to highest risk category.
By Nick Paul Taylor • Feb. 14, 2019
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Deep Dive
HIMSS19: Private sector catch-up, patient matching and standard APIs dominate first full day
Support for the HHS rules (but some concern over implementation) was the focus at the start of health IT's biggest week.
By Rebecca Pifer • Feb. 13, 2019
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J&J makes $3.4B robotic surgery buy
Johnson & Johnson gets the added boost of Auris Health's CEO and co-founder Frederic Moll joining its team, who notably co-founded market-leading Intuitive Surgical.
By Jacob Bell • UPDATED: Feb. 14, 2019 at 10:05 a.m.
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Breast implants face increased safety scrutiny in Canada
Canada's health regulator is stepping up its review after a spike in reported cases of a form of cancer known as breast implant-associated anaplastic large cell lymphoma, a week after FDA flagged similar issues.
By Susan Kelly • Feb. 13, 2019
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FDA panel backs vaginal mesh option, wants more data
The agency will consider recommendations from the obstetrics and gynecology devices panel as it makes decisions on premarket approval applications from Boston Scientific and Coloplast.
By Maria Rachal • UPDATED: Feb. 14, 2019 at 10:52 a.m.
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Edwards Lifesciences buys maker of brain oxygen monitor
The device maker agreed to pay about $100 million for CAS Medical Systems to bolster its position in smart monitoring technologies.
By Susan Kelly • Feb. 13, 2019
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Rapid test for brain injury gets FDA breakthrough status
The test measures protein biomarkers released from the brain into the bloodstream after a head trauma, producing results in as little as 90 seconds.
By Susan Kelly • Feb. 12, 2019
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Device to prevent spinal disc herniation wins PMA after setback
The approval comes more than a year after an FDA advisory panel recommended against clearing the device, citing safety concerns.
By Susan Kelly • Feb. 12, 2019
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FDA approves Orthofix's cervical disc device
The implant will compete with products including Medtronic's Prestige LP and Zimmer Biomet's Mobi-C.
By Nick Paul Taylor • Feb. 12, 2019
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Device that extracts brain tumors gains FDA breakthrough status
After yielding successful results in rats, the device is being redesigned for human use with the goal of obtaining approval to start trials by the end of the year.
By Susan Kelly • Feb. 11, 2019
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FDA finalizes guidance to strengthen its recall processes
The agency's move to improve its recall protocol across all categories follows a 2017 report from the Office of Inspector General of HHS that was particularly critical of FDA's food recall process.
By Susan Kelly • Feb. 11, 2019
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Mayo, Intermountain set partnerships for new tech hubs
The two separate pacts come as health systems seek expertise on the outside.
By Susan Kelly • Feb. 11, 2019
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FDA to exempt handful of devices from 510(k) requirements
The latest deregulatory step does not exempt the products from other mandates such as registration and listing, labeling, good manufacturing practices and medical device reporting requirements.
By David Lim • Feb. 08, 2019
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India seeks to lure medtech to growing market
Only about 400 of the roughly 5,000 medical devices marketed in India are currently regulated.
By Meg Bryant • UPDATED: Feb. 12, 2019 at 10:16 a.m.
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Boston Scientific, Coloplast transvaginal meshes in spotlight at FDA panel
Expert advisors are meeting Tuesday to weigh the risks and benefits of the controversial devices. The agency moved them into the high-risk Class III category in 2016 after thousands of adverse events were reported.
By Maria Rachal • UPDATED: Feb. 11, 2019 at 10:21 a.m.
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Bigfoot adds Owen Mumford needles to diabetes subscription service
The agreement sets Bigfoot up to provide users of its automated insulin delivery devices with pen needles.
By Nick Paul Taylor • Feb. 08, 2019