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Minute Insight: Siemens Healthineers Launches The World's First Photon-Counting CT Scanner

 
• By Reed Miller

Naeotom Alpha will allow for faster, more precise, and safer computed tomography imaging for cardiac imaging, oncology, and pulmonology.

Minute Insight

After 15 years of development, Siemens Healthineers is launching Naeotom Alpha, the first “photon-counting” computed tomography (CT) scanner.

“[Naeotom Alpha] adds clinical value for fast and reliable diagnoses by the physician by improving image quality, potentially leading to...

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Minute Insight: Medtronic May Sell Respiratory And Monitoring Units To Private Equity

 
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‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Ultrahuman Launches Home Health Monitoring

 
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FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.