Medical Devices: Page 75
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Laser vision correction procedures fell 16% in the second quarter
The slowdown raises questions about whether demand is waning or if there was a pull-through in procedures last year.
By Elise Reuter • Aug. 22, 2022 -
iStock / Getty Images Plus via Getty Images
Medical device industry poised to withstand an economic slowdown, experts say
While procedures volumes may decline, analysts said the effects likely won’t reach levels seen in 2020 or during the Great Recession.
By Ricky Zipp • Aug. 22, 2022 -
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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 -
Courtesy of Edwards Lifesciences
Edwards gets CE mark for Pascal Precision system, allowing device to be marketed in Europe
The system, which is used to treat patients with mitral or tricuspid regurgitation, is also expected to get FDA approval by the end of the year.
By Elise Reuter • Aug. 19, 2022 -
Permission granted by ResMed
Q&AFriday Q&A: ResMed CEO Mick Farrell discusses Philips recall, improving supply chain, prioritizing patients
The executive spoke about managing a 12-month patient backlog following a spike in demand due to Philips’ recall and supply constraints.
By Ricky Zipp • Aug. 19, 2022 -
Medtronic gets third Class I label in 2022 for latest HVAD recall
The latest recall is for nearly 40,000 batteries for the HeartWare Ventricular Assist Device system.
By Ricky Zipp • Aug. 19, 2022 -
Permission granted by Eargo
Eargo plans to sell its hearing aids in stores after over-the-counter ruling
Best Buy, which announced it would sell over-the-counter hearing aids in more than 300 stores, has listed the Eargo 6 as one of the products it will offer.
By Elise Reuter • Aug. 18, 2022 -
Sarah Silbiger via Getty Images
Medical device recalls hit two-year high in Q2, report finds
While the number of recalls jumped in the period, the total units affected dropped to the lowest point in five years.
By Ricky Zipp • Aug. 18, 2022 -
Chris Jackson via Getty Images
New entrants may shake up hearing-aid market after FDA clears path for OTC sales
Startups, large tech companies and even traditional hearing-aid manufacturers are expected to offer over-the-counter devices.
By Elise Reuter • Aug. 17, 2022 -
Maddie Meyer via Getty Images
Moderna, after firing newly hired CFO, finds replacement in PerkinElmer executive
The COVID-19 vaccine maker has appointed James Mock, currently PerkinElmer’s CFO, as its next finance head, three months after ousting Jorge Gomez from the role.
By Ned Pagliarulo • Aug. 17, 2022 -
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 -
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
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