Medical Devices: Page 95
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Deep Dive
Diabetes tech companies set sights on Type 2 patients as user numbers climb
With patients flocking to CGMs and insulin pumps over the past several years, companies like Dexcom, Insulet and Tandem are looking to further expand.
By Ricky Zipp • Aug. 9, 2021 -
Permission granted by iXensor
Sponsored by iXensorNew digital health solution helps mass COVID-19 testing to prevent Delta variant resurgence
To sustain reopened activities, identify outbreaks and new variants, the ability to manage testing at pace and scale has never been more urgent.
By Piers Ford • Aug. 9, 2021 -
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 -
FDA puts Class I label on Boston Scientific recall estimated to affect one-third of pacemaker line
The medtech giant took the action after discovering devices, once hailed as a growth driver, can incorrectly enter safety mode, putting patients at risk of serious injury.
By Nick Paul Taylor • Aug. 9, 2021 -
Medtronic to buy Intersect ENT in $1.1B deal targeting chronic rhinosinusitis market
Intersect ENT's implants, which deliver steroids to open sinus passageways, could position Medtronic to sell products for a condition affecting 35 million U.S. adults.
By Greg Slabodkin • Aug. 6, 2021 -
ResMed reaffirms Philips recall is up to $350M boost but held back by supply chain struggles
"Supply bottlenecks continue to restrict our access to critical electronic components, especially semiconductor chips, that ultimately limit our net production output,” CEO Mick Farrell told investors late Thursday.
By Nick Paul Taylor • Updated Oct. 29, 2021 -
Permission granted by iRhythm Technologies
iRhythm doesn't expect 2022 CMS pricing. 'It may take some time.'
Amid a challenging 2021, the cardiac monitoring player beat Wall Street revenue expectations. However, Medicare pricing uncertainty is still hanging over its future.
By Ricky Zipp • Aug. 6, 2021 -
Courtesy of BD/PRNewswire
BD results called mixed amid bullish COVID-19 testing outlook
The medtech assumes no major system-wide hospital restrictions on electives, despite the rapid spread of the delta variant, raising eyebrows from one analyst group. BD also announced CFO Chris Reidy will retire.
By Greg Slabodkin • Aug. 5, 2021 -
Kena Betancur via Getty Images
Nevro shares plunge 25% after sluggish Q2, execs brace for worse to come
Struggles in the second quarter led analysts to question whether the company is losing share to rivals such as Abbott Laboratories, Boston Scientific and Medtronic. Nevro refuted the idea that it's losing market share.
By Nick Paul Taylor • Aug. 5, 2021 -
Outpatient revenue drives hospital volume rebound in June, Kaufman Hall says
The report's year-to-date trends in outpatient visit growth add to color from medtech companies reporting electives rebounding in recent financial results.
By Hailey Mensik • Aug. 4, 2021 -
Rival to Boston Scientific's Sentinel meets skeptics at FDA advisory panel
One expert said there's "compelling evidence that [Keystone Heart] not only didn't demonstrate efficacy, but there's a potential signal of harm."
By Nick Paul Taylor • Aug. 4, 2021 -
Philips ventilator recall labeled Class I by FDA, second in as many weeks
The recall was triggered by identification of a risk that ventilators will provide lower oxygen flow. The Class I event is separate from FDA's designation in July of a recall impacting millions of Philips sleep apnea and ventilator devices.
By Nick Paul Taylor • Aug. 4, 2021 -
Roundup: Medtechs mirror pre-pandemic results in Q2 fueled by procedure volume recovery
After elective procedures began gradually rebounding in the first quarter of 2021, companies are reporting results close to or beating 2019 levels.
Aug. 3, 2021 -
Spencer Platt via Getty Images
Zimmer beats Q2 expectations, pandemic still a drag on large joint procedures
As the delta variant causes COVID-19 surges across the globe, CEO Bryan Hanson said on a Tuesday earnings call "it doesn't seem to be translating into the same revenue disruptions we've seen in the past."
By Susan Kelly • Aug. 3, 2021 -
Alex Wong via Getty Images
Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic
Comments "overwhelmingly supported" the plan to use pre-pandemic data on the cost of inpatient stays to inform CMS' rates for fiscal 2022.
By Nick Paul Taylor • Aug. 3, 2021 -
Sarah Silbiger via Getty Images
FDA ups premarket application user fees by 2.5% for FY 2022
The base PMA fee will be $329,000, though the increase is far less than the 7% hike instituted last year.
By Greg Slabodkin • Aug. 2, 2021 -
Sarah Silbiger via Getty Images
Digital health, heart disease devices feature in latest FDA breakthrough designations
Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions.
By Nick Paul Taylor • Aug. 2, 2021 -
Hillrom reverses course, will finalize $375M BardyDx acquisition
The decision ends a months-long fight by Hillrom to back out of the buy due to substantially reduced Medicare rate cuts for long-term cardiac monitoring. Hillrom expects the deal to close in the coming weeks.
By Ricky Zipp • Aug. 2, 2021 -
Pent-up demand drives Edwards' TAVR sales past forecasts, but slowdown predicted
While the delta variant was not directly discussed on the call, CFO Scott Ullem acknowledged "flare-ups of COVID in various regions" but downplayed any impact on the company's business.
By Nick Paul Taylor • July 30, 2021 -
Sarah Silbiger via Getty Images
Patient deaths called 'injury,' 'other' in FDA medical device database: study
The analysis raises questions about the complex reporting system. FDA has reached out to the lead author for reports believed to be misclassified to perform its own evaluation.
By Ricky Zipp • Updated July 30, 2021 -
Courtesy of Siemens Healthineers
Siemens Healthineers' diagnostic sales soar on EU demand for COVID-19 tests
Antigen test revenue grew more than 200% but is now expected to drop significantly. Unlike rivals Abbott and Quidel, which have seen fast-falling sales, the German medtech primarily serves Europe.
By Nick Paul Taylor • July 30, 2021 -
Supply constraints stymie Smith & Nephew's ortho recovery
Sales of knees and hips by the U.K. medtech underperformed rivals like Stryker and J&J, sending shares down in London.
By Nick Paul Taylor • July 29, 2021 -
Talk of Baxter-Hillrom tie-up grows as both companies focus on connected care
Hillrom CEO John Groetelaars in a Friday earnings call highlighted the growing importance of connected care, the focus area of Baxter's current M&A strategy. A Baird analyst said it sounded like a non-specific defense of a deal.
By Nick Paul Taylor • Updated July 30, 2021 -
Spencer Platt via Getty Images
As Stryker boosted by electives comeback, CEO downplays delta variant risk to procedures
Kevin Lobo said the uncertainty is "baked in" to the company's forecast, though some analysts noted coronavirus variants cloud the outlook for the rest of the year.
By Susan Kelly • July 28, 2021 -
Mayo Clinic named U.S. News top hospital for sixth straight year
The list, which already examines specialty areas like knee replacements, added seven new measures including care for spinal fusion and hip fracture.
By Shannon Muchmore • July 28, 2021 -
Boston Scientific tops pre-pandemic results in Q2, expects similar trends in H2
The company joins a handful of other medtechs seeming to move past the crisis, fueled by the return of elective care. CEO Michael Mahoney expects a "manageable level of COVID impact in the second half of the year."
By Ricky Zipp • July 27, 2021
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