Medical Devices: Page 22
-
Courtesy of Dexcom
Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices
The companies want clarity on what evidence would be needed for new technologies to detect undiagnosed Type 2 diabetes or prediabetes.
By Nick Paul Taylor • March 4, 2024 -
Tim Boyle via Getty Images
Baxter considers selling kidney care unit to private equity
The company expects to divest its largest segment, whether through a spinoff or a sale, in the second half of the year.
By Elise Reuter • March 4, 2024 -
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 -
Sarah Silbiger via Getty Images
GE Healthcare recalls incubators due to risk of newborns falling
The Food and Drug Administration labeled the recall as a Class I event after a serious injury was reported.
By Nick Paul Taylor • March 4, 2024 -
Permission granted by Boston Scientific
Boston Scientific gains FDA nod for drug-coated coronary balloon
BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.
By Susan Kelly • March 1, 2024 -
Permission granted by Abbott
Q&AAbbott leader on the ‘hype’ and ‘reality’ of pulsed field ablation
Christopher Piorkowski, chief medical officer for the electrophysiology business, talks about the high expectations for the new atrial fibrillation treatment.
By Susan Kelly • March 1, 2024 -
juankphoto via Getty Images
FDA responds to claim breast implant removal is ‘reasonable’ to cut cancer risk
Experts convened by the American Association of Plastic Surgeons concluded it may be “considered reasonable” to remove textured breast implants to reduce the risk of a rare cancer.
By Nick Paul Taylor • Updated March 4, 2024 -
Courtesy of Medtronic
Medtronic asks ITC to stop sales, imports of Axonics devices
The complaint is the latest move in a long-running patent fight between the two companies regarding neuromodulation devices.
By Nick Paul Taylor • March 1, 2024 -
Courtesy of Insulet Corp.
Insulet sizes up competition as Tandem, Medtronic plan new insulin patch-pumps
Insulet CEO Jim Hollingshead said the company is “very confident” in its competitive position as rivals develop their own patch pumps.
By Elise Reuter • Feb. 29, 2024 -
Courtesy of Integra Lifesciences
Integra Lifesciences CEO Jan De Witte to retire
The company is working to restart a factory in Boston after problems at the plant led to a sweeping recall in 2023. De Witte will stay with Integra until it finds a successor.
By Elise Reuter • Feb. 29, 2024 -
Courtesy of Johnson & Johnson
J&J’s pulsed field ablation system secures European approval
The device maker will vie against rivals Boston Scientific and Medtronic in the market for the new treatment for atrial fibrillation.
By Susan Kelly • Feb. 29, 2024 -
Courtesy of Royal Philips
Philips names Stryker’s Charlotte Hanneman as CFO
Abhijit Bhattacharya, who took over as CFO in 2015 and has spent 37 years with the company, will step down in October.
By Nick Paul Taylor • Feb. 29, 2024 -
Mario Tama via Getty Images
J&J begins enrolling patients in Laminar LAA pivotal trial
The new device is meant to compete with systems offered by Boston Scientific and Abbott that address blood clot risk in atrial fibrillation.
By Susan Kelly • Feb. 28, 2024 -
Permission granted by Becton Dickinson
BD life sciences president Dave Hickey to retire July 1
The company has yet to name Hickey’s replacement but plans to have a successor in place before the executive retires.
By Nick Paul Taylor • Feb. 28, 2024 -
Retrieved from Hologic on February 28, 2024
Hologic’s radiographic markers targeted in FDA safety communication
The agency has seen reports the implants can move out of position and break through the skin.
By Nick Paul Taylor • Feb. 28, 2024 -
Bruce Bennett via Getty Images
Henry Schein expects cyber incident costs to continue in 2024
The company reported a $350 million to $400 million reduction in Q4 sales due to the incident, which forced it to take some systems offline.
By Elise Reuter • Feb. 27, 2024 -
Courtesy of Integra
Integra Lifesciences to cut about 60 jobs as it closes Indiana site
Manufacturing will be transferred to a plant in Maryland as part of a strategy to bolster operational efficiency, a company spokesperson said.
By Susan Kelly • Feb. 27, 2024 -
Permission granted by Virtual Incision
Virtual Incision wins FDA de novo nod for miniaturized surgical robot
The device weighs about two pounds and fits into a tray that can be carried between operating rooms.
By Nick Paul Taylor • Feb. 27, 2024 -
Courtesy of Medtronic
Medtronic will transfer or offer comprehensive support to workers affected by ventilator exit
The company did not state how many people may be affected by the decision, announced last week, to shut down its ventilator product lines.
By Ricky Zipp • Feb. 26, 2024 -
Zhanna Hapanovich via Getty Images
Agiliti to go private in $2.5B PE deal
After the transaction’s expected close in the first half of this year, Agiliti will no longer trade on the New York Stock Exchange.
By Susan Kelly • Feb. 26, 2024 -
Sara Silbiger via Getty Images
FDA warns against using smart wearables that claim to measure blood sugar
Unauthorized smartwatches and smart rings are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency.
By Nick Paul Taylor • Feb. 23, 2024 -
Permission granted by GT Medical Technologies
Q&ANew GT Medical CEO Per Langoe on driving adoption of brain tumor therapy
Langoe, the former head of Palette Life Sciences, spoke about his plans to expand use of GT Medical’s cancer-fighting implant.
By Susan Kelly • Feb. 23, 2024 -
Permission granted by Zimmer Biomet
Zimmer receives FDA clearance for robotic shoulder system
The clearance poises the orthopedics company to be first to market with robotic-assisted shoulder replacement surgery.
By Elise Reuter • Feb. 22, 2024 -
Courtesy of Agilent
Agilent’s McDonnell to succeed retiring CEO McMullen
Mike McMullen, a 40-year veteran of Agilent and predecessor Hewlett-Packard, plans to retire on Oct. 31.
By Susan Kelly • Feb. 22, 2024 -
3M to spin off health unit April 1
The company broke down Solventum’s expected growth and risks as a standalone business in a recent federal filing.
By Nick Paul Taylor • Feb. 22, 2024 -
Flashvector via Getty Images
Better Therapeutics wins breakthrough status for health app to treat liver disease
The FDA awarded the designation after seeing evidence the digital cognitive behavioral therapy may help reduce liver fat.
By Nick Paul Taylor • Feb. 21, 2024
Previous
