Medical Devices: Page 22
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Courtesy of Ascensia Diabetes Care
Q&AAscensia’s new head of CGM talks plans for a 365-day sensor
Brian Hansen recently joined Ascensia, which markets Senseonics’ implantable glucose sensors. The current version lasts 180 days, but Senseonics is seeking FDA approval for a one-year sensor.
By Elise Reuter • Aug. 6, 2024 -
Courtesy of Inspire Medical Systems
Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy
Inspire plans to start a soft launch of the device late in 2024 and move into a full release in 2025.
By Nick Paul Taylor • Aug. 5, 2024 -
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 -
Courtesy of Johnson & Johnson
J&J launches Velys Spine surgical robotics and navigation platform
With its Velys surgical robotics portfolio, J&J aims to take market share from competitors Stryker and Zimmer Biomet.
By Nick Paul Taylor • Aug. 5, 2024 -
Courtesy of 23andMe
23andMe board rejects CEO Wojcicki’s take-private proposal
A special committee of the board said the proposal offers no premium to 23andMe’s stock price, and with a lack of committed financing, is “insufficient.”
By Elise Reuter • Aug. 2, 2024 -
Courtesy of Philips
Philips sues independent lab, alleges ‘numerous egregious errors’ in CPAP foam tests
Philips claimed PSN Labs overestimated the potential threat to patients, saying it “would have pursued a different and more focused recall” if not for the results.
By Elise Reuter • Aug. 2, 2024 -
libre de droit via Getty Images
Inari promotes Kevin Strange to CFO
Mitch Hill, who has been in the role since 2019, will retire effective Oct. 1.
By Nick Paul Taylor • Aug. 2, 2024 -
Permission granted by iRhythm Technologies
iRhythm names Daniel Wilson CFO after Brice Bobzien steps down
Along with outlining the succession plan, CEO Quentin Blackford updated investors on an earnings call about the company’s response to an FDA warning letter.
By Nick Paul Taylor • Aug. 2, 2024 -
Courtesy of GE Healthcare
GE Healthcare faces pressure in China as hospitals delay orders
Johnson & Johnson’s medtech business and Philips also cited China’s order slowdown for sluggish revenue growth in the second quarter.
By Susan Kelly • Aug. 1, 2024 -
Courtesy of Johnson & Johnson
FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall
Agency officials are working together to communicate the risk of burns tied to Megadyne electrode pads.
By Nick Paul Taylor • Aug. 1, 2024 -
Courtesy of Stryker
Stryker plans ‘very active’ M&A, ortho robot launches in 2H
After another record quarter of orthopedic robot installations, CEO Kevin Lobo hinted at a potential interest in soft tissue robots.
By Elise Reuter • July 31, 2024 -
Sarah Silbiger via Getty Images
FDA sends warning letter to defibrillator battery manufacturer
Amco makes batteries for automated external defibrillators sold by companies including Philips, Stryker and Zoll.
By Nick Paul Taylor • July 31, 2024 -
Joe Raedle via Getty Images
Patient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting
The initiative, led by new CDRH Acting Director Michelle Tarver, is intended to improve health equity by including people’s living conditions in device design.
By Elise Reuter • July 30, 2024 -
ridvan_celik via Getty Images
Asensus updates Karl Storz merger filing after investors make demands
Asensus denied that there were deficiencies in the original disclosure of the proposed takeover by Karl Storz but voluntarily expanded on details to avoid lawsuits or delays.
By Nick Paul Taylor • July 30, 2024 -
Courtesy of Tandem Diabetes Care
Q&ATandem CMO shares Mobi feedback, expansion plans
MedTech Dive caught up with Chief Medical Officer Jordan Pinsker to talk about early feedback on Tandem’s smallest insulin pump and what’s next for the device.
By Elise Reuter • July 29, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips’ orders and sales held back by China’s anti-corruption push
Hospitals in China increased internal approval cycles to comply with anti-corruption measures.
By Nick Paul Taylor • July 29, 2024 -
Permission granted by Dexcom
Dexcom shares plunge on lower sales outlook
“I’m just kind of in shock,” an analyst said on the earnings call, asking for more detail on the forecast cut.
By Elise Reuter • July 26, 2024 -
Permission granted by Abbott Laboratories
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings
A spokesperson for Abbott said the recall “may impact less than 1% of Libre 3 users in the U.S.”
By Nick Paul Taylor • July 26, 2024 -
Courtesy of Edwards Lifesciences
Edwards spends $1.2B on 2 heart device firms, extending deal streak
Alongside the acquisitions, Edwards reported a slowdown in its core TAVR business in the second quarter that sent its shares tumbling.
By Susan Kelly • July 25, 2024 -
rustycanuck via Getty Images
Owens & Minor inks $1.36B takeover of Rotech
Rotech will help Owens & Minor get closer to its 2028 sales goal with home medical equipment, including sleep and oxygen devices, hospital beds and wheelchairs.
By Nick Paul Taylor • July 25, 2024 -
Courtesy of Inspire Medical Systems
Inspire Medical chief operating officer leaving to take CEO role
Philip Ebeling said he is resigning to become president and CEO of “a private medical device company operating in the cardiology space.”
By Nick Paul Taylor • July 25, 2024 -
Permission granted by Peyton Helbert / AAMI
CDRH Director Shuren to step down after 15 years
Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices unit.
By Susan Kelly , Elise Reuter • July 24, 2024 -
Mario Tama via Getty Images
Top 5 medtech deals in the first half of 2024
The first six months of the year brought a series of multibillion-dollar deals, led by Johnson & Johnson’s $13.1 billion takeover of Shockwave Medical.
By Nick Paul Taylor • July 24, 2024 -
Retrieved from ICU Medical on July 23, 2024
ICU Medical to close Minnesota facility, cut 83 jobs
The infusion pump maker has focused on consolidating service centers and manufacturing sites since it bought Smiths Medical in 2022.
By Susan Kelly • July 23, 2024 -
Courtesy of Cook Medical
Cook Medical to sell reproductive health business to private equity firm
Astorg intends to combine the Cook assets with Hamilton Thorne, another reproductive health business it plans to buy.
By Nick Paul Taylor • July 23, 2024 -
Sarah Silbiger via Getty Images
FDA sends 2 warning letters after inspecting Chinese syringe manufacturers
One warning letter covers the production of plastic syringes for Cardinal Health.
By Nick Paul Taylor • July 22, 2024
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