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Abbott pulling ahead in glucose monitoring race: UBS doc survey
The medtech giant's FreeStyle Libre device is expected to benefit from a low-cost pricing strategy and widening insurance coverage, which some doctors believe could spur price reductions across the CGM market.
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From robots to staplers, a top 10 list of medtech safety hazards
The nonprofit ECRI identified increased use of certain devices outside of acute care settings and adoption of some technologies before safety is fully assessed as common themes in its annual ranking.
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Livongo scores biggest diabetes contract yet
Investors reacted to the news of the BCBS federal employee program agreement by bumping up Livongo's shares more than 18%.
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Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down
The company is "disappointed" the steroid delivery device, which it hopes to submit for premarket approval to FDA, did not prove superior on frontal sinus patency at 30 days when randomized against an uncoated balloon.
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Supreme Court slaps down Zimmer's request for review of $248M damages award in Stryker patent case
Zimmer Biomet exhausted its last possibility for review in the nearly nine-year-old infringement case involving a Stryker device patent, which awarded one of the highest ever amounts of enhanced damages in a patent infringement case.
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AI clinical support opens physicians to potential liabilities: JAMA
Legal considerations for doctors using clinical decision support software come amid challenges for regulators attempting to define a framework to oversee the emerging technologies.
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Mechanical thrombectomy market poised to double: analysts
Clinical data and changes to treatment protocols support wider patient access to the technology, which could benefit device makers including Stryker, Medtronic and Penumbra, analysts at Jefferies said in a research report.
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Survey finds CMS changes might slow radiation oncology purchases
One-third of physicians surveyed expect the bundled payment model to negatively affect purchasing, according to UBS analysts. Still, more than half expect to buy a new system within the next 12 months.
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AngioDynamics buys Eximo to challenge Philips for PAD market, cutting EPS targets
AngioDynamics' acquisition of Eximo Medical for up to $66 million gives it an FDA-cleared laser treatment for peripheral artery disease.
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Paclitaxel device makers roll out revised labels, fresh safety analyses
Philips and BD highlighted independent analyses published this week defending their drug-coated balloons as manufacturers update product labels acknowledging a late mortality signal in peripheral artery disease patients.
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Radiologists call for ethics guidelines on AI
"AI developers ultimately need to be held to the same 'do no harm' standard as physicians," an international coalition said.
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LabCorp Diagnostics names Ratliff as new CEO
John Ratliff, currently the CEO of LabCorp's drug development business, will take the helm of a diagnostics business that notched $1.76 billion in revenue during the second quarter.
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Lantheus strikes deal to buy Progenics, sparking investor backlash
Velan Capital, a big shareholder in Progenics, accused management of selling at a "massive discount" and preventing investors from being heard.
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IMDRF cybersecurity guidance favors total product life cycle approach
The International Medical Device Regulators Forum's draft mirrors U.S. regulators' support for a total product life cycle strategy, but does not include a tiered approach to categorizing risk laid out by FDA last year.
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Some Class I devices could get 4 extra years to comply with EU MDR
The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday in advance of an expected vote on a corrigendum to amend or modify some parts of major upcoming EU regulatory changes.
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Third-party software vulnerability could endanger medical devices, FDA and DHS warn
The alerts expand the list of vendors whose operating systems could be exploited due to vulnerabilities known as URGENT/11. Medical devices affected include an infusion pump and an anesthesia machine, FDA said Tuesday.
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Stryker inks Conformis deal to develop custom knee surgery instruments
The deal could give Stryker technology to rival devices used by Johnson & Johnson, Smith & Nephew and Zimmer Biomet.
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Venture capital investing in digital health cools in Q3: report
A quarterly update from Rock Health said funding for digital health remains near all-time highs but is slowing. A new analysis from Ropes & Gray found startups are increasingly partnering with established life sciences companies.
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Researchers automate EHR analysis for postmarket safety surveillance
Stanford researchers found an automated system extracted the vast majority of reports of complications and pain in electronic health records for hip replacement patients.
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DME industry pans CMS' gap-fill proposal, but agrees current system is "fundamentally flawed"
CMS' proposed framework to compare new technology to older items is not sufficiently fleshed out and isn't transparent enough, the American Association for Homecare said.
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Sterigenics abandons effort to reopen Willowbrook ethylene oxide sterilization facilities
The company behind the major medical device sterilization plant said it is "actively taking steps to ensure customer and patient needs continue to be met by our other facilities."
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Implanted metal devices, dental amalgam to go under FDA's microscope
Citing the "growing body of evidence" suggesting some patients have inflammatory reactions and tissue changes to metal-containing implants, the agency announced a November advisory panel to discuss the topic.
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Q&ADisruption or integration? Fitbit's health leader on the role of wearables in healthcare
Healthcare Dive spoke with Amy McDonough, general manager and SVP of Fitbit Health Solutions, about the wearables giant's competitors, its Premium offering, and how it's always been a healthcare company at the core.
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FDA designates AI software meant to boost ultrasound accessibility a breakthrough device
Led by Livongo and 23andMe veteran Andy Page, newly rebranded Caption Health anticipates pivotal data on its tech will be published in early 2020."
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Robotics, navigation systems create buzz at spine meeting
Medtronic, NuVasive and Globus Medical showed off robotic applications at the North American Spine Society gathering in Chicago. "[A]doption of more advanced platforms is not an if, but a when," Jefferies analysts wrote.
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