Medical Devices: Page 163
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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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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. 8, 2019 -
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 -
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 -
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. 8, 2019 -
Smith & Nephew has Q4 sales miss as headwinds persist
Falling sales of arthroscopic enabling technologies led the London-based company to fail to meet analyst revenue expectations for the quarter.
By Nick Paul Taylor • Feb. 7, 2019 -
Medtronic nabs expanded indication for Pipeline Flex embolization device
The device, first approved for endovascular treatment of adults with certain large or giant wide-necked intracranial aneurysms, is now also indicated for patients with certain small or medium aneurysms.
By David Lim • Feb. 7, 2019 -
Breast implant-associated lymphoma tied to at least nine US deaths, FDA says
The agency reported at least 457 unique cases of a form of non-Hodgkin lymphoma potentially linked to the device. The updated data comes weeks before a March advisory panel meets to examine known breast implant risks.
By Maria Rachal • Feb. 7, 2019 -
Boston Scientific targets structural heart, international market growth in 2019
A near-constant stream of acquisitions defined the device giant's 2018. Now, it's looking ahead to product launches in the U.S., Europe and Japan.
By Maria Rachal • Feb. 6, 2019 -
Teleflex granted FDA approval for vascular closure device
The product is designed to seal femoral punctures following vascular access medical procedures.
By Susan Kelly • Feb. 6, 2019 -
FDA draft lays out submission paths for combo products
Commissioner Scott Gottlieb said the agency will develop additional guidances outlining specific premarket considerations for combo products.
By David Lim • Feb. 6, 2019 -
BD results largely expected, beats on revenue
One year after closing the acquisition of C.R. Bard, the company said it is on track to achieve expected cost and revenue goals.
By Susan Kelly • Feb. 5, 2019 -
Deep Dive
CMS eases study parameters in depression device coverage decision
LivaNova seeks to enroll clinical trial patients beginning in the third quarter of 2019. Those patients will only need to demonstrate response rather than remission, per CMS updates to the finalized decision memo.
By Maria Rachal • Updated Feb. 19, 2019 -
Cook Medical aortic dissection device gets FDA approval
The device is designed to repair Type B dissections of the descending thoracic aorta in a minimally invasive procedure.
By Susan Kelly • Feb. 5, 2019 -
FDA warns cardiologists of high mortality in Abiomed post-approval study
The 17% survival rate in the post-approval study of its Impella temporary right heart pump system prompted FDA to write to healthcare professionals and wiped 6% of Abiomed's stock.
By Nick Paul Taylor • Feb. 5, 2019
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