Wednesday, February 01
The FDA has cleared Toshiba America Medical Systems’ Aquilion Prime CT system.
Tuesday, January 31
Despite his belief that implementation of ICD-10 is a costly endeavor with no expected benefits, thought leader John Halamka, MD, CIO of Beth Israel Deaconess Medical Center (BIDMC), CIO at Harvard Medical School, both in Boston, is helping his facility move forward and posted on his blog Jan. 31 two tools to help other facilities with the project.
Monday, January 30
The FDA’s Center for Devices and Radiological Health (CDRH) has released its ombudsman report for 2011, the first year the office’s electronic tracking system has been used to facilitate record-keeping and trending.
Wednesday, January 18
The FDA has cleared Agfa HealthCare to market its DX-M computed radiography digitizer with needle-based detectors.
Friday, January 13
The FDA has cleared Konica Minolta Medical Imaging’s Xpress CR Digital Mammography upgrade.
Thursday, January 12
The FDA has cleared Riverain Technologies Temporal Comparison x-ray software.
Wednesday, January 11
The latest version of Siemens Healthcare’s Acuson SC2000 volume imaging ultrasound system has received 510(k) clearance from the FDA and is now commercially available in the U.S.
Monday, January 09
The FDA has granted clearances for GE Healthcare's Brivo NM615, a single-head nuclear medicine gamma camera with SPECT capability.
Friday, January 06
The FDA shared in a December 2011 draft guidance its current thinking on how manufacturers and distributors of prescription drugs and medical devices should respond to unsolicited requests for information about unapproved, off-label uses related to their FDA-approved products.
Thursday, January 05
The FDA has cleared NinePoint Medical’s Nvision VLE Imaging System, a volumetric optical coherence tomography (OCT) device for endoscopic imaging.
Tuesday, January 03
The FDA has issued draft guidance describing the processes available to anyone wishing to dispute decisions and actions by the Center for Devices and Radiological Health (CDRH).
Tuesday, January 03
The FDA has issued draft guidance to clarify current review practices of premarket notification 510(k) submissions for FDA staff and manufacturers of medical devices.
Tuesday, December 20
Many practices are lagging behind in implementing software upgrades or testing health plans in advance of the transition to the new HIPAA Version 5010 electronic transaction standards prompting the Medical Group Management Association (MGMA) to call on the Department of Health and Human Services to immediately issue an expanded contingency plan.
Friday, December 16
Mobile MIM has received FDA 510(k) clearance for Mobile MIM 3.0 for diagnostic x-ray and ultrasound viewing, as well as radiation treatment plan review and approval.
Thursday, December 15
The FDA has approved the American College of Radiology (ACR) to accredit the Planmed Nuance and Nuance Excel full field digital mammography (FFDM) systems beginning Dec. 27.
Wednesday, December 14
The International Contrast Ultrasound Society (ICUS) threw its support behind a proposed FDA label change that would affect the use of Optison, an ultrasound contrast agent marketed by GE Healthcare for use in contrast-enhanced ultrasound procedures.
Wednesday, December 14
The FDA has allowed marketing of a handheld device intended to aid in the detection of intracranial hematomas using near-infrared spectroscopy. The device is expected to help determine if a CT study is needed in patients with critical head injuries.
Wednesday, December 07
The FDA has issued a Class I recall of the Draeger Medical's Infinity Acute Care System monitoring tool, which was manufactured between March and September. The product was distributed solely to the Rush University Medical Center in Chicago.
Monday, December 05
A New York City dentist is facing legal charges over her requirement that patients assign her the copyrights to any public comments they make about her dentistry practice; a requirement, the lawsuit’s plaintiff argues, that effectively prevents patients from engaging in fair and honest criticism.
Monday, December 05
As a means to thwart improper payments and reduce payment errors, the Centers for Medicare & Medicaid Services (CMS) put forth three new projects for 2012 designed to cut the Medicare fee-for-service error rate in half and recover nearly $2 billion in improper payments.
