FDA: Page 19
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Permission granted by Medtronic
Medtronic renal denervation device hits setback at FDA panel
The agency’s outside advisers found the risks of the procedure to lower blood pressure outweighed the benefits in a narrow vote.
By Susan Kelly • Aug. 24, 2023 -
Courtesy of Draeger
Draeger’s ventilator sound insulation recall triggers FDA Class I notification
The company found concentrations of a potentially carcinogenic foam component were above acceptable levels for children.
By Nick Paul Taylor • Aug. 24, 2023 -
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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 -
Courtesy of Recor
Recor wins FDA panel’s backing for high blood pressure device
The advisers found the company’s renal denervation system is safe and effective, but several panelists expressed concern about the long-term durability of the treatment.
By Susan Kelly • Aug. 23, 2023 -
Courtesy of Levita Magnetics
Levita’s surgeon-controlled arm for magnetic procedures gains 510(k) clearance
The device maker says the technology can reduce the need for an additional assistant in the operating room, driving efficiency.
By Nick Paul Taylor • Aug. 23, 2023 -
Retrieved from GE HealthCare via Business Wire.
GE HealthCare wins FDA clearance for wireless hospital vital sign monitor
The Portrait Mobile device is one of GE HealthCare’s “first major introductions in monitoring in recent years,” according to the company.
By Nick Paul Taylor • Aug. 16, 2023 -
qingwa via Getty Images
Illumina faces SEC probe over Grail acquisition
The securities regulator has asked for documents tied to the 2021 deal in addition to the conduct and compensation of members of Illumina and Grail management.
By Susan Kelly • Aug. 14, 2023 -
iStock via Getty Images
Median lag between FDA authorization and Medicare coverage hits 6 years: study
Fewer than 30% of novel medical devices obtain some Medicare coverage in the three years after regulatory authorization, researchers found.
By Nick Paul Taylor • Aug. 11, 2023 -
Courtesy of Getinge
Getinge’s heart assist pump shutdown problem given FDA Class I recall tag
The company notified healthcare providers after receiving 26 complaints about Cardiosave devices, used to support severely ill patients, unexpectedly shutting down.
By Nick Paul Taylor • Aug. 11, 2023 -
Permission granted by ZimVie
ZimVie wins FDA approval for smaller Mobi-C cervical disc
The device maker said the new product will “address the anatomical needs of the U.S. patient population.”
By Nick Paul Taylor • Aug. 10, 2023 -
Courtesy of Abbott Laboratories
Abbott lands FDA clearance of Alinity complete blood count system
The company claims the device uses less floor space and has one of the highest throughputs as it competes with diagnostic systems made by Beckman Coulter and Siemens Healthineers.
By Nick Paul Taylor • Aug. 8, 2023 -
Permission granted by Medtronic
Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts
Needham analysts predict the experts will vote in favor of Medtronic and put the device on track to target a $1 billion-plus market.
By Nick Paul Taylor • Aug. 7, 2023 -
libre de droit via Getty Images
Penumbra says stroke device delayed at least 12 months due to FDA request
The setback stalls “a meaningful new product catalyst,” but the growth of Penumbra’s other devices could cushion the impact, analysts said.
By Nick Paul Taylor • Aug. 4, 2023 -
Courtesy of Outset Medical
Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook
The halt prompted the company to predict it will now hit the bottom end of its full-year revenue range, a revision that surprised some analysts.
By Nick Paul Taylor • Aug. 4, 2023 -
Courtesy of Abbott
CMS inpatient final rule will have muted impact on medtech companies, analysts say
The CMS disclosed add-on payments that will continue in 2024 and named products that received approval under the breakthrough devices pathway.
By Nick Paul Taylor • Aug. 3, 2023 -
RiverNorthPhotography via Getty Images
Cooper scraps $875M takeover of Cook Medical business after FTC investigation
The FTC said ending the planned acquisition “ensures that critical reproductive health markets remain competitive.”
By Nick Paul Taylor • Aug. 2, 2023 -
Permission granted by Vicarious Surgical
Vicarious expects to perform first human procedure with robot next year
The company, after disclosing layoffs in February, said it has gained clarity on its regulatory pathway following pre-submission meetings with the FDA.
By Susan Kelly • July 31, 2023 -
Stock via Getty Images
GE HealthCare oxygen sensor recall gets Class I label from FDA
GE warned that the sensors can limit the effectiveness of cardiac defibrillation, expose patients to electrical currents, or give inaccurate blood oxygen readings.
By Nick Paul Taylor • July 31, 2023 -
Sara Silbiger via Getty Images
FDA shares draft guidance on studying medtech treatments for opioid use disorder
The FDA aims to address challenges including inaccurate self-reported drug use, missing data and the need to show the durability of the treatment.
By Nick Paul Taylor • July 28, 2023 -
Courtesy of Abbott Laboratories
Abbott recall of heart catheter categorized as Class I event
Abbott plans to win approval for a modified steerable product and bring it to market as a replacement for the recalled device.
By Nick Paul Taylor • July 27, 2023 -
Sarah Silbiger via Getty Images
FDA adopts new sterilization standard to support switch from ethylene oxide
The regulator said it added the alternative sterilization method to its database in response to pressure to reduce EtO use and to support supply chain resiliency.
By Nick Paul Taylor • July 26, 2023 -
Sarah Silbiger via Getty Images
FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis
The time it took for the FDA to reach 510(k) decisions decreased by 24 days, but the agency is still working through a pandemic-driven backlog of premarket approval applications.
By Nick Paul Taylor • July 24, 2023 -
Permission granted by Becton Dickinson
BD gains FDA clearance to relaunch Alaris infusion pump after recalls
The company will fix or replace older devices still in use at hospitals as it ramps up to resume sales in its market-leading infusion business.
By Susan Kelly • July 24, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA provides safety update on hernia repair mesh as medtech companies face lawsuits
The FDA’s analysis of adverse event reports describes problems including pain, injury and disability.
By Nick Paul Taylor • July 17, 2023 -
iStock via Getty Images
AdvaMed says CMS radiotherapy rate cut proposal will limit patient access
The proposed rule includes a 2% reduction in reimbursement, continuing a trend that has seen the CMS cut payments by more than 20% over the past decade, according to the the American Society for Radiation Oncology.
By Nick Paul Taylor • July 17, 2023 -
Adeline Kon/Healthcare Dive/MedTech Dive
What the new CMS payment proposals mean for device makers
Ophthalmic device company Glaukos could benefit from the proposed changes, analysts wrote.
By Elise Reuter • July 14, 2023
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