Medical Devices: Page 174
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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 -
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 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
FDA redefines 'least burdensome' as critics fear chilling effect on reviewers
A watchdog argues the guidance is the agency's latest step to speed device approvals at the expense of robust patient protection.
By David Lim • Feb. 5, 2019 -
Oxipit AI-based tool for chest X-ray analysis gets CE mark
The Lithuania-based startup is betting the system can help radiologists increase productivity, detect hard-to-catch pathologies, decrease error rates and serve as a second opinion.
By Susan Kelly • Feb. 4, 2019 -
Jacob Bell/MedTech Dive
FDA announces warfarin test strips, IV fluid transfer systems recalls
The agency identified separate Class I recalls addressing malfunctions in certain Roche Diagnostics test strips and Vial2Bag fluid transfer systems made by West Pharmaceutical Services.
By Susan Kelly • Feb. 4, 2019 -
Stryker issues voluntary field action after 6 deaths linked to defibrillator bug
The device giant obtained the product as part of its $1.28 billion acquisition of Physio-Control in 2016.
By Susan Kelly • Feb. 4, 2019 -
Zimmer Biomet narrowly beats Q4 expectations, looks to Rosa knee soft launch
RBC Capital Markets analysts predicted the company's second half of 2019 is primed for faster growth once Rosa and other new knee product launches kick in.
By David Lim • Feb. 1, 2019
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