Policy & Regulation: Page 2
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Courtesy of Labcorp
Labcorp wins FDA OK for pan-solid tumor liquid biopsy
Shakti Ramkissoon, Labcorp’s medical lead for oncology, said the test could allow laboratories and oncologists to profile solid tumors when tissue samples are limited or unavailable.
By Nick Paul Taylor • Aug. 6, 2024 -
Courtesy of Inspire Medical Systems
Inspire wins FDA approval for obstructive sleep apnea neurostimulator therapy
Inspire plans to start a soft launch of the device late in 2024 and move into a full release in 2025.
By Nick Paul Taylor • Aug. 5, 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 -
Karen Ducey/Getty Images via Getty Images
Experts fear patient harm from FDA’s lab developed test rule
Decreased access to diagnostic tests, worsening patient care and practice closures are among the concerns the AMA and others have raised as the regulation takes effect.
By Susan Kelly • Aug. 5, 2024 -
Courtesy of Johnson & Johnson
J&J launches Velys Spine surgical robotics and navigation platform
With its Velys surgical robotics portfolio, J&J aims to take market share from competitors Stryker and Zimmer Biomet.
By Nick Paul Taylor • Aug. 5, 2024 -
Courtesy of Johnson & Johnson
FDA, Health Canada team up to raise awareness of J&J’s Megadyne recall
Agency officials are working together to communicate the risk of burns tied to Megadyne electrode pads.
By Nick Paul Taylor • Aug. 1, 2024 -
Sarah Silbiger via Getty Images
FDA sends warning letter to defibrillator battery manufacturer
Amco makes batteries for automated external defibrillators sold by companies including Philips, Stryker and Zoll.
By Nick Paul Taylor • July 31, 2024 -
Joe Raedle via Getty Images
Patient shares a day in the life with diabetes at FDA’s first Home Health Hub meeting
The initiative, led by new CDRH Acting Director Michelle Tarver, is intended to improve health equity by including people’s living conditions in device design.
By Elise Reuter • July 30, 2024 -
Sarah Silbiger via Getty Images
FDA officials outline benefits of AI lifecycle management
The digital health leaders detailed a seven-stage diagram for how the healthcare industry could monitor artificial intelligence software development.
By Nick Paul Taylor • July 30, 2024 -
Courtesy of Guardant Health
Guardant wins FDA approval for colon cancer blood test
Colorectal cancer screening rates could increase if the Shield test appeals to people who have avoided colonoscopies or stool-based tests, the company said.
By Susan Kelly • July 29, 2024 -
Permission granted by Abbott Laboratories
Abbott recalls Freestyle Libre 3 sensors due to incorrect glucose readings
A spokesperson for Abbott said the recall “may impact less than 1% of Libre 3 users in the U.S.”
By Nick Paul Taylor • July 26, 2024 -
Permission granted by Peyton Helbert / AAMI
CDRH Director Shuren to step down after 15 years
Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices unit.
By Susan Kelly , Elise Reuter • July 24, 2024 -
Courtesy of Business Wire
Guardant settles allegations it violated the False Claims Act
The settlement resolves claims that an oncologist ordered significantly more tests after Guardant hired two people the physician recommended for jobs at the company.
By Nick Paul Taylor • July 23, 2024 -
Sarah Silbiger via Getty Images
FDA sends 2 warning letters after inspecting Chinese syringe manufacturers
One warning letter covers the production of plastic syringes for Cardinal Health.
By Nick Paul Taylor • July 22, 2024 -
Sarah Silbiger via Getty Images
FDA creates communication ‘super office’ at CDRH
The changes are part of a broader reorganization intended to increase organizational agility and help the agency meet user fee commitments.
By Nick Paul Taylor • July 16, 2024 -
Jemal Countess via Getty Images
House committee tells FDA to suspend lab developed test rule
Lawmakers said the final rule carries “the risk of greatly altering the United States’ laboratory testing infrastructure.”
By Nick Paul Taylor • July 15, 2024 -
Courtesy of Hamilton Medical
Hamilton recalls ventilators that may fail to restart
One death and one injury have been tied to the safety problem, the Food and Drug Administration said in a recall notice.
By Nick Paul Taylor • July 15, 2024 -
Sarah Silbiger/Getty Images via Getty Images
FDA finalizes guidance on studying opioid use disorder treatments
The Center for Devices and Radiological Health is aiming to help companies manage challenges such as inaccurate participant reports of drug use.
By Nick Paul Taylor • July 12, 2024 -
Anna Moneymaker / Staff via Getty Images
Deep DiveFDA’s lab developed test rule could be first check on agency’s power post-Chevron
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
By Susan Kelly , Elise Reuter • July 11, 2024 -
Courtesy of BD
FDA warns BD blood culture bottle shortage could impact diagnosis
BD said reduced availability of blood culture media bottles due to supplier issues has prevented it from meeting global demand.
By Nick Paul Taylor • July 11, 2024 -
Courtesy of Medtronic
Medtronic recalls endotracheal tubes over blockage risk
The Food and Drug Administration has told healthcare providers to stop using the two affected types of endotracheal tubes.
By Nick Paul Taylor • July 11, 2024 -
Mark Wilson via Getty Images
Federal officials step down from health AI group’s board
HHS officials Micky Tripathi and Troy Tazbaz resigned from their roles as non-voting members of the Coalition for Health AI, an industry group working to create standards for artificial intelligence in healthcare.
By Emily Olsen • July 10, 2024 -
iStock via Getty Images
Roche wins CE mark for its first CGM
The clearance positions Roche to challenge Abbott and Dexcom for the European continuous glucose monitor market.
By Nick Paul Taylor • Updated July 10, 2024 -
Sarah Silbiger via Getty Images
Pulse drops 510(k) plan for PFA device after FDA requests clinical data
Analysts said the AFib device is now unlikely to come to market before late 2026.
By Nick Paul Taylor • July 9, 2024 -
Retrieved from Cardinal Health on July 02, 2024
FDA continues crackdown on plastic syringes made in China
The agency has issued import bans for four manufacturers, and multiple companies have recalled affected syringes. Check out MedTech Dive’s roundup of the news.
By Elise Reuter • July 2, 2024 -
Sarah Silbiger via Getty Images
FDA to expand total product life cycle program
Officials plan to start accepting radiological and ophthalmic medical devices into the program, designed to accelerate medtech innovation, in October.
By Nick Paul Taylor • July 2, 2024
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