Medical Devices: Page 72
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Permission granted by Philips
Philips’ next CEO, Roy Jakobs, provides ‘continuity’ amid ongoing recall: Barclays
Roy Jakobs currently leads the company’s connected care business and has helped oversee its recall response.
By Ricky Zipp • Aug. 17, 2022 -
gchutka via Getty Images
Visibly wins FDA clearance for self-administered online vision test
The agency has placed restrictions on the test, limiting it to adults aged 22 to 40 years and cautioning that it only gives “supportive recommendations.”
By Nick Paul Taylor • Aug. 17, 2022 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Patrik Stollarz / Staff via Getty Images
FDA reviews rise in Philips respiratory device reports, including 44 deaths
The agency received more than twice as many reports linked to foam breakdown from May to July than from April 2021 to April 2022.
By Nick Paul Taylor • Aug. 17, 2022 -
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 -
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
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