Medical Devices: Page 23
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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 -
Sarah Silbiger via 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 -
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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
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 -
Getty Images via Getty Images
Invitae files for Chapter 11 bankruptcy
The genetic testing company hopes to keep its employees on payroll as it works through a court-overseen sale.
By Elise Reuter • Feb. 14, 2024 -
Permission granted by Senseonics
Senseonics gains expanded Medicare coverage for implantable CGM
Three Medicare Administrative Contractors will start covering the Eversense E3 CGM for people who only take basal insulin.
By Elise Reuter • Feb. 13, 2024 -
gorodenkoff via Getty Images
Robotic knee replacement revision rate no better than traditional surgery: study
Orthopedics companies such as Stryker and Zimmer Biomet have promoted robotic knee surgery as a more accurate technique.
By Nick Paul Taylor • Feb. 13, 2024 -
kieferpix via Getty Images
Medtech companies lay off thousands in 2024, continuing last year’s trend
With the year drawing to a close, Masimo, Smith & Nephew and Boston Scientific are among the medtech companies to announce job cuts.
By MedTech Dive Staff • Updated Dec. 17, 2024 -
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Masimo finds pulse oximeter is accurate in Black patients with low pulse strength
A recent study, which examined a Masimo device, found low pulse strength and darker skin pigmentation are associated with pulse oximeter errors.
By Nick Paul Taylor • Feb. 12, 2024 -
Courtesy of Abbott Laboratories
FDA meeting document ‘generally supportive’ of Abbott Triclip: analysts
J.P. Morgan analysts noted the agency’s queries on safety but added the document has “simple voting questions” that “all lean towards approval.”
By Nick Paul Taylor • Feb. 12, 2024 -
Permission granted by Illumina
Illumina cut 12% of global staff over past year: CEO
The genomics company, which initiated a fresh round of layoffs last month, expects to finalize its Grail divestiture by the end of June, Jacob Thaysen said Thursday.
By Susan Kelly • Feb. 9, 2024 -
kieferpix via Getty Images
Livanova to lay off 137 people at Pittsburgh facility
A spokesperson said the layoffs are part of the company's plan to shut down its advanced circulatory support business.
By Ricky Zipp • Feb. 9, 2024 -
Courtesy of Fresenius
Fresenius Medical Care brings dialysis technology to US with FDA clearance
The company plans to start a broad market launch next year and push to establish hemodiafiltration as the new standard of care.
By Nick Paul Taylor • Updated March 8, 2024 -
Courtesy of Illumina
Illumina to lay off 111 people at San Diego headquarters
The job cuts, expected by March 12, include senior management positions, scientists and engineers.
By Susan Kelly • Feb. 8, 2024 -
Permission granted by Zimmer Biomet
Zimmer Biomet to cut about 540 jobs
A spokesperson told MedTech Dive that the company will lay off about 3% of its workforce as part of a restructuring.
By Elise Reuter • Updated Feb. 8, 2024 -
Courtesy of Insulet Corp.
Insulet wins CE mark for integration of insulin pump with Abbott CGM
The clearance positions Insulet to sell the integrated Type 1 diabetes product in Europe beginning in the first half of the year.
By Nick Paul Taylor • Feb. 8, 2024 -
Courtesy of Boston Scientific
Boston Scientific’s spinal cord stimulators approved for non-surgical back pain
FDA backing for the Wavewriter SCS systems allows the company to challenge Abbott and Nevro.
By Nick Paul Taylor • Feb. 7, 2024 -
Courtesy of Edwards Lifesciences
How Edwards’ Evoque valve won an early nod from the FDA
The heart valve specialist has the chance to shape a new tricuspid market with the first-of-its-kind device, like it did 20 years ago in TAVR, CEO Bernard Zovighian said.
By Susan Kelly • Feb. 7, 2024
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