Medical Devices: Page 44
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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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
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 -
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 -
Permission granted by Peyton Helbert / AAMI
CDRH’s Shuren backs expansion of TAP program to speed device approval
The FDA started the Total Product Lifecycle Advisory Program to help medtech companies cross the “valley of death” by getting agency feedback early.
By Elise Reuter • Feb. 21, 2024 -
Getty Images
FDA warns industry of ‘fraudulent’ third-party data in device applications
The agency has seen a rise in data that are fabricated, duplicated or otherwise unreliable in premarket submissions.
By Nick Paul Taylor • Feb. 21, 2024 -
Sarah Silbiger via Getty Images
Medical device recall system ‘failing to meet the needs of public health,’ physicians find
Amid a GAO review of recalls, the physicians advised the watchdog to revisit unique device identifiers and clarify the FDA’s enforcement authority.
By Nick Paul Taylor • Feb. 20, 2024 -
UK medical device reviewers form new association
The group intends to help the medical device sector navigate a post-Brexit regulatory landscape.
By Susan Kelly • Feb. 20, 2024 -
Courtesy of Medtronic
Medtronic exits ventilator business, creates new patient monitoring and respiratory unit
The decision reverses a strategy announced more than a year ago to separate the slower-growth patient monitoring and respiratory interventions businesses.
By Ricky Zipp • Feb. 20, 2024 -
Courtesy of Medtronic
Medtronic names Raman Venkatesh as first chief sustainability officer
Venkatesh will be responsible for leading the development and execution of Medtronic’s environmental sustainability strategy.
By Nick Paul Taylor • Feb. 16, 2024 -
Permission granted by Canary Medical
Q&ACanary CEO Bill Hunter talks smart knee implant progress, new heart device
The company collaborated with Zimmer Biomet on its Persona IQ device, which is slated for a full market release this year. Canary is also working on an implantable monitor for heart failure patients.
By Elise Reuter • Feb. 15, 2024 -
Sara Silbiger via Getty Images
Smiths Medical recalls syringe pumps for software malfunction
The FDA categorized the recall as Class I, noting that the software faults may cause pumps to fail, delaying or interrupting therapy.
By Nick Paul Taylor • Feb. 15, 2024 -
Courtesy of Masimo
Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter
The company's OTC device, which costs nearly $300, will compete with consumer pulse oximeters that are widely available but lack FDA clearance.
By Nick Paul Taylor • Feb. 14, 2024 -
Courtesy of Abbott
FDA advisory panel overwhelmingly backs Abbott’s Triclip
The expert panel voted unanimously in favor of the safety of the tricuspid valve device, despite questions about a potential placebo effect in the trial.
By Ricky Zipp • Feb. 14, 2024 -
Courtesy of Samsung Electronics
Samsung wins de novo nod for watch that detects sleep apnea
The FDA created special controls that provide a path to market for other developers of over-the-counter devices.
By Nick Paul Taylor • Feb. 14, 2024
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