Medical Device News
Latest industry news, regulatory updates, and announcements from trusted sources.
Intuitive expands push into cardiac market with CE mark
After de-emphasizing heart surgery for decades due to limits with its earlier platforms, the surgical robot maker is eyeing the large market in cardiovascular disease treatment.
Read Full Article →Lab test providers want Medicare payment reform. Will Congress pass it?
Facing maximum Medicare payment cuts, test providers Quest Diagnostics and Labcorp are urging lawmakers to revamp the rate-setting process, but getting a bill through Congress this year will be a chal…
Read Full Article →Aptar Pharma and Macquarie University partner on drug delivery project
Aptar and Macquarie's collaboration will evaluate how factors, including how formulation variables influence drug delivery with Aptar’s dry powder inhaler platform. The post Aptar Pharma and Macquarie…
Read Full Article →FDA clears Marani Health’s remote maternal monitoring system
Marani's M•wrap for foetal and and maternal heart signal monitoring is intended to give patients an at-home monitoring option versus travelling to a clinic. The post FDA clears Marani Health’s remote …
Read Full Article →Revvity introduces GSP T1D 3plex kit for type 1 diabetes detection
Revvity has launched the GSP T1D 3plex kit, which aims to support population screening programmes for children at risk of developing T1D months or years before symptoms emerge. The post Revvity introd…
Read Full Article →FDA grants breakthrough designation to Glytec’s Glucommander Pediatrics
The US FDA has granted breakthrough device designation to Glytec’s proposed insulin dosing recommendation algorithm, Glucommander Pediatrics, for hospitalised newborns and infants under two years old.…
Read Full Article →FDA nominee Overton parries vaccine questions at Senate hearing
Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
Read Full Article →AI will inflate healthcare costs before lowering them, Oz says
AI will “turbocharge” medical billing and drive up costs in the short term, CMS Administrator Dr. Mehmet Oz warned Wednesday. But he says the pain is worth it for long-term savings.
Read Full Article →Grail multicancer detection test wins FDA advisers’ backing
Members of the molecular and clinical genetics panel said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings.
Read Full Article →Anaconda Biomed raises $56m for catheter portfolio’s advance
The funds will support Anaconda's clinical development aims and the completion of its pivotal IDE study. The post Anaconda Biomed raises $56m for catheter portfolio’s advance appeared first on Medical…
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