FDA: Page 13
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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 -
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 -
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 -
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 -
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 -
Sara Silbiger via Getty Images
Top CDRH official to retire
William Maisel, director of the Office of Product Evaluation and Quality, will retire this spring, an FDA spokesperson confirmed.
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 -
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 -
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 -
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 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 -
Sarah Silbiger via Getty Images
Hologic wins FDA clearance for AI-enabled cervical cancer screening system
The product creates digital images of Pap test slides and uses an AI algorithm to identify cells for review.
By Nick Paul Taylor • Feb. 5, 2024 -
Wavebreakmedia via Getty Images
FDA panel recommends new standards for pulse oximeters amid bias concerns
Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.
By Elise Reuter • Feb. 5, 2024 -
Permission granted by Veeva Systems
FDA to reclassify most high-risk IVDs, easing path to clearance
The effort comes ahead of the regulator’s plan to finalize a rule that would expand its oversight of laboratory-developed tests.
By Susan Kelly • Feb. 5, 2024 -
Retrieved from Food and Drug Administration.
Cardinal Health expands recall of Monoject syringes amid compatibility problems
The company said there have been no reports of patient deaths, but noted there is a risk of serious injury or death.
By Nick Paul Taylor • Feb. 5, 2024 -
Sara Silbiger via Getty Images
FDA publishes final rule to harmonize quality system requirements with global standard
The agency extended the transition timeline from one to two years, pushing back the effective date to 2026.
By Nick Paul Taylor • Feb. 1, 2024 -
Joe Raedle/Getty Images via Getty Images
Califf backs increased LDT oversight despite industry opposition
At a Wednesday event, the FDA commissioner named the laboratory-developed test proposal as a top priority and addressed questions on AI.
By Ricky Zipp • Feb. 1, 2024 -
Patrik Stollarz / Staff via Getty Images
FDA receives more reports of deaths linked to Philips’ recalled respiratory devices
From the start of July to the end of September last year, the agency received more than 7,000 reports that contained 111 deaths.
By Nick Paul Taylor • Feb. 1, 2024 -
Sarah Silbiger via Getty Images
FDA extends deadline for comments on role of digital health in diabetes detection
The agency is seeking answers on how digital health technologies could be used in the detection of prediabetes and Type 2 diabetes.
By Nick Paul Taylor • Jan. 31, 2024 -
JohnnyGreig via Getty Images
The top medtech trends in 2024
Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.
By MedTech Dive Staff • Jan. 31, 2024
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