FDA: Page 73
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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 -
Myriad shares plunge 40% after missing targets, slashing outlook
Investors punished the genetic test maker after it reported double-digit drops in sales of its key cancer and depression products.
By Nick Paul Taylor • Nov. 5, 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 -
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 -
Price transparency rule on ice in win for providers
The final outpatient payments rule from CMS did include plans to implement controversial site neutral provisions and cuts to 340B drug payments, both of which have been successfully challenged in court.
By Samantha Liss • Nov. 1, 2019 -
Trump picks MD Anderson's Stephen Hahn for FDA chief
Pending Senate confirmation, the Texas cancer center's chief medical executive and former American Society for Radiation Oncology board member will fill the agency's top seat.
By Maria Rachal • Updated 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 -
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 -
FDA puts J&J's Ethicon surgical stapler recall in top risk category
Ethicon had learned of seven serious injuries and one death related to the recalled products by the time it began pulling the devices from the market.
By Nick Paul Taylor • Oct. 31, 2019 -
It's official: EC confirms 2-year Eudamed delay
The database will now go live in May 2022, giving the industry a reprieve and more time to complete projects.
By Dana Elfin • Oct. 30, 2019 -
CMS proposes lifting restrictions on NGS cancer testing
The agency revised its proposed national coverage determination after receiving more than 80 comments, with potential plans to extend coverage of next generation sequencing tests to earlier-stage and hereditary cancers.
By Nick Paul Taylor • Oct. 30, 2019 -
Surmodics gets breakthrough tag for critical limb ischemia device
The Minnesota medtech, which is also in the midst of testing a drug-coated balloon licensed by Abbott, now has a boost from FDA in bringing to market a sirolimus-delivering device designed to prevent amputation and death.
By Nick Paul Taylor • Oct. 30, 2019 -
Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body
BSI joins Dekra Germany as designated under the In Vitro Diagnostic Regulation ahead of its 2022 implementation date.
By Dana Elfin • Oct. 28, 2019 -
UK regulator mulls blocking Illumina's $1.2B PacBio takeover
The watchdog said the union "would result in a significant reduction of competition," leading some analysts to predict the deal won't go through.
By Nick Paul Taylor • Oct. 25, 2019 -
Fresenius gets breakthrough tag for clot-preventing dialysis device
The dialysis services giant is testing a system that features a polymer designed to cut the risk of blood clotting without the use of medication.
By Nick Paul Taylor • Oct. 25, 2019 -
Device to ID obstructions in post-PCI patients wins breakthrough status
Swiss startup CorFlow Therapeutics created the device to both assess and treat microvascular obstruction in patients after percutaneous coronary intervention.
By Nick Paul Taylor • Oct. 24, 2019 -
FDA pitches black box warning for breast implants
The agency said it heard "loud and clear" worries of patients who testified at an advisory panel regarding a potential link between certain implants and a form of lymphoma, as well as other adverse events.
By Kim Dixon • Oct. 23, 2019 -
Device to halt knee implant infections gets breakthrough tag
Garwood Medical Devices is looking to raise $3 million in Series B funding by the end of this year.
By Nick Paul Taylor • Oct. 23, 2019 -
Canon gets FDA nod for AI tech to enhance CT images
Rising use of CT scans, which expose patients to far more radiation than X-rays, has intensified focus on the risks of the imaging technique, particularly in the pediatric population.
By Nick Paul Taylor • Oct. 22, 2019 -
Sens. Warren, Cassidy press FDA on difference between servicing and remanufacturing
The agency does not require servicers, who face fewer regulatory requirements than remanufacturers, to register with FDA.
By David Lim • Oct. 18, 2019 -
AdvaMed lobbies Trump to repeal medical device tax (again)
The trade organization has successfully delayed the levy for years, but the latest moratorium expires at year's end.
By Nick Paul Taylor • Oct. 18, 2019 -
Key committee pitches adding UDIs to payer claim forms, called 'huge step'
If a unique device identifier is captured when a high-risk product is implanted, providers will be able to detect complications more quickly, Joe Drozda, the director of outcomes research at Mercy Health, told MedTech Dive.
By David Lim • Oct. 17, 2019 -
ViewRay bucks payment fears in field dubbed 'not dead' yet
The radiation oncology company received eight new orders for its MRI-guided Linac, easily beating Jefferies' forecast.
By Nick Paul Taylor • Oct. 16, 2019 -
Two weeks from Brexit deadline, UK floats device contingency
A no-deal Brexit would not meet any of MedTech Europe's four priorities.
By Nick Paul Taylor • Oct. 15, 2019 -
Hospitals, manufacturers could donate cybersecurity software under proposed regs
With the cost of protecting systems from malicious hackers increasing, the idea to tweak the anti-kickback laws recognizes some physician practices don't have the resources or expertise to keep pace, one lawyer told MedTech Dive.
By David Lim • Oct. 14, 2019
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