Medical Devices: Page 182


  • Stryker closes $1.4B K2M acquisition

    The medical device giant says the deal will augment its own spine and neurotechnology offerings.

    By David Lim • Nov. 9, 2018
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    Monteris modifies brain ablation device to counter safety risk

    FDA cleared a new model that features a fiber optic probe designed to stop the original heating problem.

    By Nov. 9, 2018
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline
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    Trendline

    New 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
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    Premier to acquire software company Stanson Health for $51.5M

    Software-as-a-service provider Stanson's product pipeline includes a tool to give prior authorizations in near real time.

    By Meg Bryant • Nov. 8, 2018
  • Rising Cordis costs drag on Cardinal Health profits

    Increased expenditures at the troubled medical device unit stifled profitability.

    By Nov. 8, 2018
  • BD posts long-awaited clinical data on Lutonix balloon in CLI

    If the approval and commercialization go to plan, BD thinks the below-the-knee opportunity is worth about $250 million a year.

    By Nov. 8, 2018
  • Shoulder device sales power Wright to beat-and-raise Q3

    Strong growth emboldened the company to raise its outlook for the second successive quarter. Jefferies analysts wrote there is "no reason we can see to suggest Wright can't maintain double-digit underlying sales growth."

    By Nov. 8, 2018
  • Long-term data backs Medtronic drug-coated balloon for PAD

    Five-year study data on the company's Admiral device to treat peripheral artery disease showed it continued to outperform standard angioplasty.

    By Nov. 7, 2018
  • Fresh off of strong quarter, ResMed buys MatrixCare

    The sleep apnea company is betting the acquisition will augment its existing software-as-a-service offerings such as Brightree and HEALTHCAREfirst.

    By David Lim • Nov. 6, 2018
  • Becton Dickinson Q4 revenue up, some Wall Street misses

    The device company aggressively remade itself in recent years to focus on higher-growth areas within the medical technology sector.

    By Nov. 6, 2018
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    Abbott, J&J take part in FDA's NEST real world evidence pilot

    The test cases will assess the role of RWE in proactive post-market surveillance, the evaluation of ablation devices and other activities across the medical device lifecycle.

    By Nov. 6, 2018
  • FDA approves 2 devices to aid in thyroid surgery

    The products sold by Fluoptics and AiBiomed are designed to help surgeons locate parathyroid tissue or glands, which can be difficult to see during a procedure.

    By Nov. 5, 2018
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    FDA extends time to comply on unique device identification

    The agency said it is extending the compliance date for Class I and unclassified devices in response to industry concerns that reworking devices in inventory would be a costly burden.

    By Nov. 5, 2018
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    Gap between perception, reality of connected medical device security, survey finds

    Nearly two-thirds of health IT professionals trust traditional security measures like firewalls to protect connected medical devices from cyber attack, according to a new Zingbox survey, but that trust may be misplaced.

    By Meg Bryant • Nov. 2, 2018
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    Deep Dive

    Midterms 2018: Key health ballot votes in the states

    It's not just Congress up for grabs in Tuesday's midterm elections. From Medicaid expansion to dialysis treatments to nurse staffing ratios, here's a snapshot of key votes, the odds and what they could mean for the industry.

    By David Lim , Tony Abraham , Rebecca Pifer , Samantha Liss • Nov. 2, 2018
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    FDA deficient on device cybersecurity readiness, watchdog says

    The inspector general called the agency's postmarketing efforts to police cyber threats to medical devices insufficient. The FDA said the report paints "an incomplete and inadequate" picture of the agency's oversight.

    By Nov. 2, 2018
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    CMS finalizes DME bidding program overhaul despite cost

    Administrator Seema Verma said the final rule will increase patient access to medical products, but an August GAO report found beneficiaries are able to get needed items under the current paradigm.

    By David Lim • Nov. 2, 2018
  • The FDA logo on a glass pane at the agency's campus in Silver Spring, Maryland.
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    Patient deaths following Getinge device shutdowns prompt FDA warning

    The agency has reports of three patient deaths following intra-aortic balloon pump malfunctions.

    By Nov. 2, 2018
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    Zimmer gets FDA nod for knee implant as portfolio strategy advances

    Clearance coincided with first use of the device maker's knee surgery robot. The CEO has been vague about how it will differentiate its knee and spine devices from rival products, such as those sold by Mazor Robotics and Stryker.

    By Nov. 1, 2018
  • Moody's boosts growth forecast for US medical device industry

    The ramped up prediction comes in response to strong sales of relatively new, high-margin products at companies such as Edwards Lifesciences and Medtronic.

    By Nov. 1, 2018
  • NuVasive CEO says spine industry poised to consolidate

    The spinal device maker said it is moving from belt-tightening to investment mode to take advantage of improving market conditions.

    By Oct. 31, 2018
  • Baxter posts 'frankly disappointing' sales as hurricane aftereffects linger

    "It is now becoming clear that the market dynamics have fundamentally shifted, at least in the near- to mid-term," Baxter CEO José Almeida said on the quarterly conference call with investors.

    By Oct. 31, 2018
  • Baxter earns CE mark for new renal replacement system

    Launch of the PrisMax device builds on the company's Prismaflex technology for filtering the blood of critically ill patients, and is a key event for the company's acute therapies business.

    By Oct. 30, 2018
  • Genentech releases more data on refillable eye implant

    Study results showed that vision and anatomical outcomes in wet AMD patients who received the device, and dosed every six months or longer, were comparable to ranibizumab dosed every four weeks.

    By Oct. 30, 2018
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    Leerink predicts Inspire to clear coverage blockade, quickly grow sleep apnea sales

    The upbeat estimates assume another major insurer will cover the implant in the next 18 months.

    By Oct. 30, 2018
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    Look out device makers — Amazon set to sell glucose monitors, blood pressure cuffs

    The products will be sold under the brand name Choice through a partnership with Arcadia Group, a consultancy firm with a history of partnering with big brand retailers like Walmart.

    By Samantha Liss • Oct. 29, 2018