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FDA Grants Expanded Approval of Siemens Healthineers Mammography Platform for Digital Breast Tomosynthesis
Posted on Comments Off on FDA Grants Expanded Approval of Siemens Healthineers Mammography Platform for Digital Breast Tomosynthesis
The inclusion of the 3D imaging technology PlatinumTomo in the Mammomat B.brilliant device reportedly enables clinicians to obtain 50-degree 3D images in less than five seconds.
Read the full article at: www.diagnosticimaging.com
Continue Reading »FDA Clears Automated Dosimetry with the Monte Carlo Method for Radionuclide Therapy
Posted on Comments Off on FDA Clears Automated Dosimetry with the Monte Carlo Method for Radionuclide Therapy
The clearance may facilitate improved standardization and efficiency of dosimetry-guided, theranostic applications of radiopharmaceutical therapy.
Read the full article at: www.diagnosticimaging.com
Continue Reading »Contego Medical’s Neuroguard IEP system receives US FDA approval for carotid revascularisation
Posted on Comments Off on Contego Medical’s Neuroguard IEP system receives US FDA approval for carotid revascularisation
Contego Medical today announced the US Food and Drug Administration’s (FDA) premarket approval (PMA) of the Neuroguard IEP system for carotid revascularisation.The company shares in a press release that clinical studies of the Neuroguard IEP system, including the PERFORMANCE I trial and PERFORMANCE…
Read the full article at: neuronewsinternational.com
Continue Reading »FDA Grants Breakthrough Device Designation for Emerging High-Intensity Focused Ultrasound Treatment of Pancreatic Cancer
Posted on Comments Off on FDA Grants Breakthrough Device Designation for Emerging High-Intensity Focused Ultrasound Treatment of Pancreatic Cancer
The Sonire Therapeutics ultrasound system is currently being studied for the treatment of patients with unresectable pancreatic cancer refractory or intolerant to first-line chemotherapy.
Read the full article at: www.diagnosticimaging.com
Continue Reading »FDA releases its stance on regulating AI in healthcare
Posted on Comments Off on FDA releases its stance on regulating AI in healthcare
The Agency says AI can transform multiple aspects of healthcare, but it is difficult to fully oversee and regulate the technology without the assistance of all sectors involved.
Read the full article at: www.mobihealthnews.com
Continue Reading »FDA Opens Performance Pathway To Four Dental Device Types
Posted on Comments Off on FDA Opens Performance Pathway To Four Dental Device Types
Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a…
Read the full article at: insights.citeline.com
Continue Reading »SymPhysis Medical raises €2.2m as it prepares for FDA approval
Posted on Comments Off on SymPhysis Medical raises €2.2m as it prepares for FDA approval
SymPhysis Medical has developed a device to address the condition of fluid in the chest experienced by many end-of-life cancer patients.
Read the full article at: www.siliconrepublic.com
Continue Reading »Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50
Posted on Comments Off on Hungary’s New Designation Pushes EU Medical Device Notified Body Count To 50
Having 50 notified bodies under the Medical Device Regulation is a landmark achievement for the EU after a long and slow, journey to reach this point.
Read the full article at: insights.citeline.com
Continue Reading »Digital treatment for insomnia awaiting NHS funding secures FDA clearance
Posted on Comments Off on Digital treatment for insomnia awaiting NHS funding secures FDA clearance
A cost-saving UK digital health innovation that’s still awaiting NHS England funding, more than two years after NICE recommended its national adoption in the NHS, will soon be made available to patients in the US after it secured FDA clearance.
Read the full article at: www.med-technews.com
Continue Reading »European Parliament softens stance on overhaul of medical device rules | Euronews
Posted on Comments Off on European Parliament softens stance on overhaul of medical device rules | Euronews
Timetable for reforms of rules affecting medical devices not defined after calls for thorough impact assessment.
Read the full article at: www.euronews.com
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