Medical Devices: Page 79
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Courtesy of Outset Medical
Outset lands VA contract for portable hemodialysis system in ‘modest’ boost for sales
Stifel analysts said the contract could generate additional sales of as much as $50 million over five years.
By Nick Paul Taylor • Aug. 16, 2022 -
Ijubaphoto via Getty Images
Hearing aids to be available over the counter following final FDA rule
Hearing aids were introduced for over-the-counter purchase in mid-October
By Elise Reuter • Aug. 16, 2022 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Philips
Philips CEO Frans van Houten to step down in October amid recall woes; Jakobs named successor
The leadership change follows a July announcement that the company is in talks on a consent decree with the Department of Justice.
By Ricky Zipp • Aug. 16, 2022 -
nortonrsx via Getty Images
Smartphone-linked blood pressure monitors fail to beat traditional devices, study finds
Individuals have been able to check their blood pressure at home using devices that lack connectivity features for years, raising the question of whether the technology improves outcomes.
By Nick Paul Taylor • Aug. 16, 2022 -
Boston Scientific acquires biomaterials firm Obsidio to bolster embolization business
Obsidio’s Gel Emobolic Material technology was cleared by the FDA in July.
By Ricky Zipp • Aug. 15, 2022 -
ChooChin via Getty Images
J&J, other orthopedics companies faced unequal pandemic recovery in second quarter
As procedure volumes increased, some businesses such as Zimmer Biomet gained share while others lagged.
By Elise Reuter • Aug. 15, 2022 -
Permission granted by Becton Dickinson
BD’s recall of emergency vascular access devices labeled Class I event by FDA
The company first announced the recall in June. There have been no reports of serious injuries or deaths tied to the issue.
By Nick Paul Taylor • Aug. 15, 2022 -
Courtesy of Abbott
Abbott will invest $450M in Ireland to expand EU production of FreeStyle Libre CGMs
The move, which will give Abbott a new facility in Kilkenny and enhance its existing site in Donegal, comes amid stiffening competition with Dexcom.
By Nick Paul Taylor • Aug. 15, 2022 -
NataliaSokko via Getty Images
ResMed CEO Farrell says supply chain ‘very much in flux’ amid signs of improvement
Mick Farrell told investors on an earnings call Thursday that one improvement has been the supply of semiconductor chips. Still, the executive stressed the importance of prioritizing medical devices.
By Ricky Zipp • Aug. 12, 2022 -
Courtesy of Abbott
Abbott blood test predicts death, unfavorable outcomes in traumatic brain injury patients, study finds
Abbott is pursuing FDA clearance for the breakthrough-designated TBI test to expand access to a diagnostic that predicted death and severe disability.
By Nick Paul Taylor • Aug. 12, 2022 -
Permission granted by Senseonics
Q&AFriday Q&A: Francine Kaufman, Senseonics’ CMO, talks growing users, a 365-day CGM, doctor recruitment
Kaufman spoke about Senseonics’ release of its 180-day CGM in the U.S., developing a unique product in the diabetes technology market and competing with Dexcom and Abbott.
By Ricky Zipp • Aug. 12, 2022 -
Sean Gallup via Getty Images
‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say
Medical device manufacturers argue the agency’s current rules on cybersecurity requirements are too restrictive and should be phased in gradually.
By Elise Reuter • Aug. 11, 2022 -
Courtesy of Insulet Corp.
Insulet raises forecast as Omnipod 5 sales climb; Tandem expects tougher market in second half
Both insulin pump companies grew revenue by more than 10% in the second quarter, but Tandem lowered its 2022 forecast amid a tougher market, while Insulet increased its guidance.
By Ricky Zipp • Aug. 11, 2022 -
Medtronic issues Class I recall of implantable cardioverter defibrillators in U.S.
The devices may deliver a reduced shock during high-voltage therapy, about 79% of the programmed energy.
By Nick Paul Taylor • Aug. 11, 2022 -
Spencer Platt/Getty Images via Getty Images
Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales
While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.
By Nick Paul Taylor • Updated Aug. 10, 2022 -
Boston Scientific says it’s investigating allegations of anti-bribery law violations
The company says the issue is centered on its operations in Vietnam.
By Nick Paul Taylor • Aug. 10, 2022 -
Spencer Platt/Getty Images via Getty Images
Eargo’s Q2 revenue slides amid decline in hearing-aid shipments
The company’s gross system shipments fell by more than 8,000 when compared to the year-earlier period.
By Ricky Zipp • Aug. 9, 2022 -
Sarah Silbiger via Getty Images
FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for OTC sales
The move comes after the agency proposed the creation of a new category of over-the-counter hearing aids in October.
By Nick Paul Taylor • Aug. 9, 2022 -
Rrraum via Getty Images
BD begins tender offers for up to $500M in debt to advance repayment strategy
The spinoff of the diabetes business to form Embecta has provided proceeds that BD plans to use to pay down $1 billion in debt, according to Fitch Ratings.
By Nick Paul Taylor • Aug. 9, 2022 -
Naomi Eide/MedTech Dive
Senate passes $740B bill to lower healthcare costs after months of wrangling
While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.
By Nick Paul Taylor • Aug. 8, 2022 -
Sarah Silbiger via Getty Images
FDA’s breakthrough device designations poised for another record year
At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.
By Nick Paul Taylor • Aug. 8, 2022 -
Permission granted by Kevin Fu
Q&AFriday Q&A: FDA’s former medical device cybersecurity director says more investment needed in staffing
The FDA and medtech companies will need more cybersecurity staff to stay ahead of hackers, says Kevin Fu, who is now focused on building that workforce for the government, private sector and academia.
By Elise Reuter • Aug. 5, 2022 -
Permission granted by iRhythm Technologies
iRhythm raises 2022 revenue forecast after record number of registrations in Q2
The cardiac monitor maker increased the low end of its forecast by $5 million, although executives expect a flat third quarter compared to the second quarter due to macroeconomic pressures.
By Ricky Zipp • Aug. 5, 2022 -
Courtesy of Suralignhttps://www.surgalign.com/wp-content/uploads/2020/07/Spine.png
SEC accuses surgical implant business of pulling forward sales to hit targets
According to the SEC, Surgalign, known at the time as RTI Surgical, shipped future orders ahead of schedule to pull forward revenues and mask disappointing sales figures.
By Nick Paul Taylor • Aug. 5, 2022 -
Hospitals have low level of accountability for connected device breaches
Of the 43% of organizations that reported a data breach in the past two years, 88% said at least one connected device was a contributing factor to the breach, according to a new report.
By Rebecca Pifer • Aug. 4, 2022
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