FDA: Page 17
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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FDA shares draft guidance on studying medtech treatments for opioid use disorder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 -
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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 -
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 -
Sarah Silbiger/Getty Images via Getty Images
Problem with Draeger transport ventilators categorized as Class I recall by FDA
Draeger contacted customers last month after receiving reports that devices stopped providing ventilation because of depleted batteries.
By Nick Paul Taylor • July 14, 2023 -
Permission granted by Urologic
Urotronic wins FDA approval to challenge Boston Scientific, Teleflex for prostate market
The company’s Optilume device combines balloon dilation and the delivery of paclitaxel to treat symptoms linked to an enlarged prostate.
By Nick Paul Taylor • July 13, 2023 -
artJazz via Getty Images
Illumina hit by EU with maximum €432M fine for Grail acquisition
The European Commission called Illumina’s closing of the deal without its approval an “unprecedented” move that undermines its system for regulating the competitive landscape.
By Susan Kelly • July 12, 2023 -
Courtesy of U.S. Food and Drug Administration
Analysis shows paclitaxel-coated devices unlikely to increase death risk, leading FDA to withdraw warning
The FDA’s decision to remove mortality warnings from device labels is a boost to manufacturers of paclitaxel-coated devices.
By Nick Paul Taylor • July 12, 2023 -
Sara Silbiger via Getty Images
J&J Megadyne unit’s electrode pad recall labeled Class I over burn risk
The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths.
By Nick Paul Taylor • July 12, 2023 -
Permission granted by ShockWave
Analysts expect a reimbursement boost for Shockwave coronary artery-clearing device
The analysts think growth expectations for the company are too low and have set their earnings estimate for next year 15% above Wall Street’s consensus.
By Nick Paul Taylor • July 11, 2023 -
Permission granted by Medtronic
Medtronic secures Medicare coverage for MiniMed 780G insulin pump
Medtronic has begun processing orders and will start shipping devices over the next few weeks.
By Nick Paul Taylor • July 10, 2023 -
Adam Berry via Getty Images
European guidelines offer support for renal denervation in hypertension, boosting Medtronic, ReCor
Medtronic hailed the updated guidelines as a “turning point” for the use of renal denervation in treating high blood pressure.
By Nick Paul Taylor • July 6, 2023 -
Courtesy of U.S. Food and Drug Administration
Startup’s fast-acting wound treatment gel gets FDA nod for use in humans
Cresilon raised $25 million last year as part of a push to expand its wound-gel product for animals into human health.
By Nick Paul Taylor • July 5, 2023 -
artJazz via Getty Images
EU MDR costs could cause device shortages for children, medical groups warn
The cost of certification under new medical device regulations in Europe is a barrier to manufacturers that make devices for small groups of patients, medical associations said.
By Elise Reuter • June 29, 2023 -
Retrieved from Istock.
FDA seeks feedback on technologies that can enable healthcare at home
The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.
By Nick Paul Taylor • June 29, 2023 -
Sarah Silbiger via Getty Images
FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use
The agency in March cleared NuVasive to market its Precice limb-lengthening system for use in the femur and tibia of children aged 12 years and up.
By Nick Paul Taylor • June 29, 2023 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
FTC proposes updates to merger review that could slow healthcare dealmaking
A new rule proposed by antitrust regulators would ask companies to provide additional information about planned mergers to help the Federal Trade Commission keep pace with increased deal volume and complexity.
By Emily Olsen • June 28, 2023 -
Sarah Silbiger/Getty Images via Getty Images
Teleflex recall of separating vascular catheters labeled Class I event
The company began the recall in May after receiving 83 complaints, including 18 reports of injuries, related to the fault.
By Nick Paul Taylor • June 28, 2023 -
Brian Tucker
Proposed EtO limits garner criticism from device industry, praise from occupational health groups
Lobbyists representing medical device companies say the proposed policy would reduce capacity at commercial sterilizers by as much as 50%.
By Elise Reuter • June 27, 2023 -
CMS proposes pathway to earlier breakthrough device coverage
The voluntary plan would allow manufacturers to address evidence gaps through studies designed to answer specific questions.
By Susan Kelly • Updated June 23, 2023
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