Medical Devices: Page 19
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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 -
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 -
Explore the Trendline➔
Sitthiphong via Getty ImagesTrendlineMedical 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 -
Q&A
Tandem 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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Q&A
‘Our next frontier is prediction’: Medtronic on AI and heart disease
Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.
By Susan Kelly • July 22, 2024 -
Dental implant maker Osstem in talks to acquire Zimvie: report
Bloomberg first reported M&A rumors in June when Zimvie was approached about a takeover.
By Elise Reuter • July 19, 2024 -
Intuitive’s da Vinci 5 robot launch ‘well ahead’ of Wall Street expectations
Early customer feedback on the new robot suggests features such as improved ergonomics and vision technology are helping drive adoption, executives said.
By Susan Kelly • July 19, 2024 -
GE Healthcare to buy AI software from Intelligent Ultrasound for $51M
After purchasing Caption Health last year, GE Healthcare plans to add another artificial intelligence acquisition to the company.
By Nick Paul Taylor • July 19, 2024 -
Abbott previews PFA, over-the-counter CGM markets
Electrophysiology sales held up against rivals’ launches of pulsed field ablation systems. Meanwhile, Abbott is gauging sales of its first OTC CGMs.
By Elise Reuter • July 18, 2024 -
Deep Dive
Medtech firms have cut more than 14,000 jobs in the past 18 months
Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.
By Jasmine Ye Han , Ricky Zipp , Elise Reuter • Updated July 25, 2024 -
Qiagen to cut 175 employees, close Michigan PCR test plant
The layoffs and plant closure are part of a restructuring plan that Qiagen estimates will cost about $400 million.
By Elise Reuter • July 17, 2024 -
J&J medtech fails to meet growth expectations
CFO Joe Wolk told investors Wednesday that Johnson & Johnson’s medical device business missed the company’s 5%-7% growth forecast in the second quarter.
By Ricky Zipp • July 17, 2024 -
Masimo sues activist investor Politan, postpones annual meeting
The latest turn in the recent drama comes days after proxy advisory firms ISS and Glass Lewis backed two Politan nominees for Masimo’s board.
By Susan Kelly • July 16, 2024 -
FDA creates communication ‘super office’ at CDRH
The changes are part of a broader reorganization intended to increase organizational agility and help the agency meet user fee commitments.
By Nick Paul Taylor • July 16, 2024 -
J&J, Abbott and Intuitive start medtech earnings season
The companies’ financial results will offer a glimpse at the current health of medtech markets.
By Nick Paul Taylor • July 16, 2024