Industry News: Page 850

7D Surgical gets nods for spine surgery system

By AuntMinnie.com staff writers

7D Surgical has received 510(k) clearance from the U.S. Food and Drug Administration and a medical device license from Health Canada for 7D Surgical System, its machine-vision image-guided surgery (MIGS) system for spine surgery.

January 22, 2017

OssDsign gets FDA clearance for facial reconstruction

By AuntMinnie.com staff writers

Swedish cranial and facial reconstruction implant firm OssDsign said it has received U.S. Food and Drug Administration (FDA) clearance for its flagship OssDsign Cranial product for reconstructing defects during cranioplasty via 3D-printed implants.

January 19, 2017

GE Healthcare sees revenue, profit growth in Q4

By AuntMinnie.com staff writers

GE reported that its GE Healthcare division saw revenues grow 4% and operating profit rise 10% for the fourth quarter.

January 19, 2017

FDA issues 2 new guidances on medical products

By AuntMinnie.com staff writers

U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf announced that the agency has issued two new draft guidances about medical product communications.

January 19, 2017

FDA launches Oncology Center of Excellence

By AuntMinnie.com staff writers

The U.S. Food and Drug Administration (FDA) announced that it is establishing an Oncology Center of Excellence. Dr. Richard Pazdur will serve as its director.

January 19, 2017

MRI can help avoid unnecessary prostate cancer biopsies

By Wayne Forrest

By first undergoing a multiparametric MRI scan, more than 25% of men with suspected prostate cancer could avoid a needle biopsy guided by transrectal ultrasound, according to a study published online January 19 in Lancet.

January 19, 2017

Scientists use DTI-MRI to map Tasmanian tiger brain

By AuntMinnie.com staff writers

Scientists have used MRI and diffusion-tensor imaging (DTI) to reconstruct the brain architecture and neural networks of the thylacine, or Tasmanian tiger, an extinct carnivorous marsupial native to Tasmania, according to research published online January 18 in PLOS One.

January 18, 2017

Philips taps new CMO for health informatics

By AuntMinnie.com staff writers

Royal Philips, the parent company of Philips Healthcare, has appointed Dr. Roy Smythe as its new chief medical officer (CMO) for health informatics.

January 18, 2017

ACA has boosted colorectal cancer diagnoses

By AuntMinnie.com staff writers

The Affordable Care Act (ACA) increased the number of diagnoses of early-stage colorectal cancer by 8% among U.S. seniors ages 65 and older between 2011 and 2013, according to a study published in the January issue of Health Affairs.

January 18, 2017

Hitachi combines units into Hitachi Healthcare America

By AuntMinnie.com staff writers

Hitachi Ltd. has unveiled plans to consolidate its Hitachi Aloka Medical America and Hitachi Medical Systems America subsidiaries into one entity called Hitachi Healthcare America.

January 18, 2017

Zetta nets FDA OK for CT dose software

By AuntMinnie.com staff writers

Zetta Medical Technologies has received clearance from the U.S. Food and Drug Administration (FDA) to market its Zia iterative reconstruction software designed for low-dose CT protocols.

January 18, 2017

Total-body PET scanner project adds expertise

By AuntMinnie.com staff writers

A consortium that is developing a total-body PET scanner called Explorer has chosen two partners to help create the system.

January 18, 2017

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