The Latest
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Courtesy of Hologic
Hologic allies with Bayer to support uptake of contrast-enhanced mammography
The companies will provide a product package and training intended to support adoption of the imaging technique.
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Courtesy of CMR Surgical
CMR Surgical secures $165M for its robot expansion
The new funding will also support product innovation efforts as the company builds a position in the fast-growing robotic surgery market.
Updated Sept. 21, 2023 -
"Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
Limited resources constrain federal oversight of medical device ads, GAO finds
U.S. agencies took 322 enforcement actions related to medtech advertising between 2018 and 2022.
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Courtesy of Hamilton Medical
Hamilton Medical recalls ventilators for control board problem
The issue can cause a short circuit or lead the capacitor to lose function, interrupting ventilation.
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Courtesy of Stryker
Stryker adds minimally invasive bunion device to fast-growing extremities portfolio
The company is making the case that the system reduces recurrence, scar size and opioid use.
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Stefan Zaklin via Getty Images
CMS leader defends breakthrough device reimbursement proposal at House hearing
Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies pathway to five reviews a year.
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Carl Court via Getty Images
EU antitrust officials make surprise inspections at cardiovascular device company
The unnamed company may have violated EU rules against abusing a dominant market position, the European Commission said.
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Sarah Silbiger/Getty Images via Getty Images
FDA makes device conformity testing scheme permanent to streamline assessments
The FDA has delivered on a MDUFA V commitment by turning ASCA into a permanent, voluntary accreditation program.
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Courtesy of Boston Scientific
Boston Scientific to buy back pain treatment company Relievant for $850M
The company, which makes a treatment for chronic back pain, is expected to bring in more than $70 million in sales this year.
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Mario Tama via Getty Images
J&J starts trial of pulsed field ablation catheter with mapping feedback
Omnypulse expands J&J’s portfolio of investigational devices with a catheter that gathers contact force data.
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peakSTOCK via Getty Images
Gates Foundation grants GE HealthCare $44M for AI ultrasound tech
The money will go to subsidiary Caption Health to make AI tools to help with maternal care and pediatric lung health.
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Courtesy of U.S. Food and Drug Administration
FDA releases draft guidance for studying weight loss devices
The documents arrive amid questions about whether new medicines will cut demand for weight loss procedures.
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artJazz via Getty Images
MedTech Europe says MDR, IVDR framework needs ‘structural reform’
Patients may face delayed access to treatments unless changes are made to the new regulatory system, 35 European trade groups warned in an open letter.
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Sara Silbiger via Getty Images
FDA finalizes breakthrough device changes to target health inequities
The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions.
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Lakshmiprasad S via Getty Images
Beacon Biosignals receives FDA clearance for sleep tracking headband
The company’s at-home device, the Dreem 3S, has six EEG electrodes to capture brain activity.
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Permission granted by Bigfoot Biomedical
Q&ABigfoot CEO talks Abbott acquisition, future of diabetes tech
Jeffrey Brewer hopes to see more integrated solutions for people with diabetes, starting with the company’s partnership with Abbott.
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Lintau Zhang via Getty Images
Hospital, lab equipment makers brace for China demand slowdown
Chinese purchases represent 10% to 20% of revenues on average for leading companies in the life science tools sector, according to Jefferies research.
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Courtesy of GE HealthCare
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI
The organizations will collaborate on the application of AI to MRI and the automation of diagnostic and interventional ultrasound.
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Courtesy of Johnson & Johnson
J&J to phase out Janssen name in corporate rebrand
Janssen will be recast as Johnson & Johnson Innovative Medicine, while the company’s medical device business will remain Johnson & Johnson MedTech.
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Permission granted by Abbott Laboratories
Abbott’s neurostimulator recall, with 73 injuries reported, deemed Class I by FDA
The company contacted customers in July after receiving complaints from patients who were unable to exit the devices’ MRI mode.
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dzika_mrowka via Getty Images
Insulin pump-makers grapple with questions about GLP-1s
The new class of weight loss drugs has caused a stock selloff, but is unlikely to “meaningfully change the long-term outlook for diabetes,” analysts wrote.
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AlexeyKamenskiy via Getty Images
FTC closes probe of Resonetics’ $900M medical nitinol purchase
The acquisition would give Resonetics a leading supplier of the alloy for the medical device industry.
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Sarah Silbiger via Getty Images
FDA finalizes biocompatibility guidance for devices that touch the skin
The agency chose not to make some major requested revisions, such as including metals in the scope of the guidance.
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Permission granted by Orthofix
Orthofix fires CEO, CFO after investigation finds misconduct
The executives engaged in “repeated inappropriate and offensive conduct” inconsistent with the company’s values, Orthofix said.
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Sarah Silbiger via Getty Images
TB deaths prompt FDA warning on reducing transmission risk
The agency outlined risk mitigation strategies for cell and tissue products after two recipients of bone matrix products died.
