Medical Devices: Page 20
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Sarah Silbiger via Getty Images
FDA to expand total product life cycle program
Officials plan to start accepting radiological and ophthalmic medical devices into the program, designed to accelerate medtech innovation, in October.
By Nick Paul Taylor • July 2, 2024 -
Courtesy of BusinessWire/Masimo
Masimo COO says he’ll resign if CEO Kiani is forced out
Activist investor Politan Capital Management is attempting to remove longtime Masimo leader Joe Kiani, claiming the company lacks independent oversight.
By Susan Kelly • July 1, 2024 -
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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 -
Mario Tama/Getty via Getty Images
Medtech M&A may pick up after mixed start to 2024: analysts
The annual number of medtech acquisitions is on course to slump to its lowest level since 2017, according to Needham.
By Nick Paul Taylor • July 1, 2024 -
Patrik Stollarz / Staff via Getty Images
FDA walks back injury, death reports on recent Philips BiPAP recall
The agency now says 10 injuries and seven deaths are associated with the problem. The updated numbers match figures shared by Philips and are significantly below the original report.
By Elise Reuter • Updated July 11, 2024 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
Dexcom to lay off 535 employees in California
A company spokesperson said Dexcom is centralizing its U.S. manufacturing operations in Arizona and repurposing its San Diego facility.
By Ricky Zipp • June 27, 2024 -
Courtesy of HP
Medtronic CFO Karen Parkhill leaving for HP
Truist analysts wrote that “there could be some investor angst until a permanent successor is announced.”
By Nick Paul Taylor • June 27, 2024 -
Peter Macdiarmid via Getty Images
Zimvie mulls sale after takeover approaches: Bloomberg
Zimvie is reportedly working with an adviser to assess its options after strategic investors and industry players showed interest in a deal.
By Nick Paul Taylor • June 26, 2024 -
Courtesy of Dexcom
Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech.
Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.
By Elise Reuter • June 26, 2024 -
mathisworks via Getty Images
Beyond Air cut more than 20% of employees
BTIG analysts said the company’s near-term cash needs, “disappointing sales results and lack of progress on profitability metrics” are concerning.
By Nick Paul Taylor • June 26, 2024 -
Permission granted by Embecta
Embecta touts its insulin patch pump at ADA
Embecta said its device, with a larger insulin reservoir, addresses an unmet need for people with Type 2 diabetes.
By Elise Reuter • June 25, 2024 -
Retrieved from Ascensia Diabetes Care on June 25, 2024
Senseonics tips 365-day CGM to double 2025 sales
Senseonics is in talks with insulin pump manufacturers about integrating its implantable Eversense continuous glucose monitor with their devices.
By Nick Paul Taylor • June 25, 2024 -
Courtesy of Insulet Corp.
Insulet seeks label expansion of Omnipod 5 for Type 2 diabetes
At the American Diabetes Association meeting, Insulet shared study results showing improvements in blood glucose and quality of life.
By Elise Reuter • June 24, 2024 -
Sarah Silbiger via Getty Images
Cardinal Health recalls procedure kits over plastic syringes made in China
Cardinal listed more than 500 catalog numbers in its recall notice and told customers to remove and discard the syringes.
By Nick Paul Taylor • June 24, 2024 -
Courtesy of Orthofix
Orthofix’s president of global orthopedics resigns
Kimberley Elting will end her eight-year stint at the company in July, continuing Orthofix's recent trend of executive turnover.
By Nick Paul Taylor • June 24, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips Respironics to end manufacturing at two Pennsylvania plants: report
Philips said it would transition operations from the two sites to a third-party manufacturer. The plan will cut 300 jobs, according to the Pittsburgh Post-Gazette.
By Elise Reuter • June 21, 2024 -
Courtesy of Tandem Diabetes Care
Tandem names Jean-Claude Kyrillos as chief operating officer
The appointment gives Kyrillos a leading role in work to expand the insulin delivery company’s global operations and achieve profitable growth.
By Nick Paul Taylor • June 21, 2024 -
Mario Tama via Getty Images
J&J creates open digital platform for surgical applications
J&J at first will focus on surgical video, telepresence and planning and limit access to select hospitals. It plans to make the platform more widely available in 2025.
By Nick Paul Taylor • June 21, 2024 -
Sasirin Pamai via Getty Images
Globus Medical gets FDA nod for ortho robot
With the clearance, Globus could gain share in the roughly $15 billion market for reconstructive orthopedic surgery, RBC Capital Markets analyst Shagun Singh said.
By Elise Reuter • June 20, 2024 -
Retrieved from Dermtech on June 20, 2024
Dermtech files for Chapter 11, lays off 20% of staff
The diagnostic test maker will continue to hunt for a buyer for its skin cancer detection patch.
By Nick Paul Taylor • June 20, 2024 -
David McNew via Getty Images
Former Stimwave CEO gets 6 years in prison for fake device scheme
The case centered on allegations that Stimwave marketed a dummy piece of plastic as a receiver of radiofrequency energy.
By Nick Paul Taylor • June 20, 2024 -
Sarah Silbiger/Getty Images via Getty Images
FDA official sets out approach to AI in medical devices
Developing quality assurance practices for AI models should be a priority, said Troy Tazbaz, director of the CDRH’s Digital Health Center of Excellence.
By Elise Reuter • June 18, 2024 -
Courtesy of Boston Scientific
Boston Scientific buys Silk Road Medical for $1.26B
Silk Road developed a minimally invasive procedure to prevent stroke in patients with carotid artery disease.
By Susan Kelly • June 18, 2024 -
Courtesy of Medtronic
Medtronic’s president of global regions set to retire in June
Medtronic made Rob ten Hoedt one of four regional leaders after it bought Covidien almost 10 years ago.
By Nick Paul Taylor • June 18, 2024 -
Permission granted by Boston Scientific
PFA devices are changing AFib treatment. The next wave could grow the market further.
New pulsed field ablation systems from Boston Scientific and Medtronic are already reshaping the cardiac ablation market, but upcoming devices could spur even greater adoption.
By Susan Kelly • June 17, 2024 -
Sarah Silbiger via Getty Images
Merit Medical recalls plastic syringes made by Jiangsu Shenli
Merit’s recall comes amid broader FDA scrutiny of plastic syringes made in China.
By Nick Paul Taylor • June 17, 2024
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