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FDA Plans eMDR System Updates

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) plans to update the FDA’s electronic medical device reporting (eMDR) system to reflect updates to the FDA Form 3500A and other system enhancements. The FDA Form 3500A is...

FDA Clears GE Healthcare’s Deep Learning-Based MR Image Reconstruction

GE Healthcare has announced U.S. FDA 510(k) clearance of AIR Recon DL. “This pioneering technology, using a deep learning-based neural network, improves the patient experience through shorter scan times while also increasing diagnostic confidence with better image...

GlobalData: Impact of COVID-19 on diagnostic imaging not as severe compared to other areas

The impact of COVID-19 on diagnostic imaging (DI) procedures will not be as severe compared to other therapy areas, such as aesthetics and dental, since only 38.7% of these procedures are elective and expected to drop due to the COVID-19 pandemic, according to...

FDA Approves Cerianna

PETNET Solutions Inc., a Siemens Healthineers company, and Zionexa USA, a wholly owned subsidiary of Zionexa SAS, have announced that the Food and Drug Administration (FDA) has approved Cerianna (fluoroestradiol F 18) injection for intravenous use. Cerianna...

People on the Move — July 2017

Hologic of Marlborough, Massachusetts has added Charles J. Dockendorff to its Board of Directors. Dockendorff is a former EVP and CFO for Covidien, having joined Tyco Healthcare, its Kendall Healthcare Products segment, as a controller in 1989.

As a result of its acquisition of the medical imaging business of PerkinElmer Inc. Varex Imaging Corporation has made Brian Giambattista SVP and GM of X-ray detectors for the company’s combined imaging detector business. Giambattista has been president of the PerkinElmer medical imaging business since 2008. Rick Colbeth, the former Varex GM of X-ray detectors, has been promoted to SVP of Engineering of its X-ray detector business.

Acertara of Longmont, Colorado added Nicholas Ellens to oversee its acoustic power testing lab. Ellens joins Acertara from the Johns Hopkins University Department of Radiology MR research faculty, where he worked on focused ultrasound and MR-guided high intensity focused ultrasound (HIFU) projects.

Angela Alistar has been named medical director of medical oncology at Atlantic Health System Cancer Care of Morristown, New Jersey. Alistar is a translational research specialist, and joins Atlantic Health System from the Wake Forest School of Medicine, where she led the GI oncology team. She is a member of the American Society of Clinical Oncology, the American Society of Hospice and Palliative Care Medicine, and the American Society of Hematology.

In its acquisition of C.R. Bard Inc., BD (Becton, Dickinson and Company) of Franklin Lakes, New Jersey will create a new business, BD Interventional, to which Bard employees will report. Bard chairman and CEO Tim Ring will join the BD Board of Directors, as will another Bard director as yet unnamed. BD is also promoting Tom Polen from EVP and president of the BD Medical Segment to president of BD; he will oversee BD’s Medical, Life Sciences and new Interventional segments.

Richard S. Isaacs has been named executive director and CEO of The Permanente Medical Group (TPMG) and president-CEO of Mid-Atlantic Permanente Medical Group (MAMPG) of Oakland, California. Isaacs succeeds Robert Pearl in both roles as well as co-CEO of the National Permanente Executive Committee of The Permanente Federation. He has served as physician in chief for the Kaiser Permanente South Sacramento Medical Center since 2005.

Brainlab AG of Munich, Germany has announced that CFO Joseph A. Doyle plans to retire after nearly 20 years with the company. Doyle joined Brainlab as VP in 1998, and two years later was promoted to CFO; he was also the company’s COO from 2001 to 2009. After his retirement, Doyle will remain with Brainlab as an advisor.

Shockwave Medical of Fremont, California named Doug Godshall its president and CEO. Godshall was CEO and director of HeartWare International Inc., which was acquired by Medtronic in August 2016. At Boston Scientific, he was president of vascular surgery, vice president of business development, and a member of its operating committee. Godshall replaces Shockwave Medical co-founder, Daniel Hawkins.

Cleveland Clinic President and CEO Toby Cosgrove is stepping down after nearly 13 years at the helm. Cosgrove plans to vacate his post by the end of 2017, but has been invited to continue with the organization in an advisory role. Cosgrove helped the Cleveland Clinic grow into the largest employer in Ohio, with nearly $9 billion in annual revenues and a staff of more than 50,000. The search for his replacement is underway, and according to the organization, will result in the hiring of a practicing physician.

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