FDA Targets GE, Siemens MRIs in Class II Recalls
The FDA issued a pair of Class II recalls on MR imaging systems. The unrelated announcements affect some devices made by GE Healthcare and Siemens. Read more here.
Aetna CMO: UDIs in claims forms necessary to improve care
Transparency when it comes to doctors and hospitals tracking the devices that go into patients is necessary to improve quality and reduce costs, according to Harold Paz, executive vice president and chief medical officer at Aetna. Read more here.
Regulators, Experts Outline Plan for New National Medical Device Surveillance System
Medical devices—and the patients who use them—would substantially benefit from a National Medical Device Postmarket Surveillance System (MDS), charges a new report authored by the Brookings Institution's Engelberg Center for Health Reform with support from the US Food and Drug Administration (FDA). Read more here.
Joint Commission releases requirements for imaging services
The Joint Commission has released updated accreditation requirements for diagnostic imaging service providers in U.S. hospitals and ambulatory care centers. Although the new rules emphasize imaging safety in positive ways, more specific guidance is needed, according to safety advocates. Read more here.
Bill Filed to Repeal Medical Device Excise Tax
January 8, 2015 -- Bipartisan legislation to repeal the 2.3% medical device excise tax has been introduced into the U.S. House of Representatives. The Protect Medical Innovation Act (HR 160) is sponsored by Reps. Erik Paulsen (R-MN) and Ron Kind (D-WI) and was introduced with 254 original co-sponsors. Paulsen and Kind introduced a similar bill to repeal the [...]
Support Builds for Medical Device Tax Repeal
A bipartisan group of lawmakers predicted Wednesday that the House could repeal ObamaCare’s tax on medical device sales by the end of March. Read more here.
FDA Expands Medical Device Surveillance Program
After five years, the FDA is transitioning its Mini-Sentinel program to a full-scale Sentinel System. “We’re on our way to developing a nationwide rapid-response electronic active surveillance system, Sentinel System, for monitoring the safety of FDA-regulated drugs and other products,” wrote Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in [...]
FDA pushes forward with UDI system development
The U.S. Food and Drug Administration is pressing "full steam ahead" to develop a unique device identifier (UDI) system for medical devices, according to Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. Read more here.
CMS Says Yes to CT Lung Cancer Screening for Seniors
Bucking a negative assessment from its own appointed review panel, the U.S. Centers for Medicare and Medicaid Services (CMS) today approved CT lung cancer screening for Medicare recipients, saying the evidence is sufficient to justify screening high-risk individuals until the age of 74 years. Read more here.
JAMA IM Editorials Weigh in on Lung Cancer Screening
With Medicare on the cusp of a momentous decision about whether to pay for CT lung cancer screening, the issue is the focus of a pair of editorials published October 13 in JAMA Internal Medicine. Taking opposite sides, the articles one last time outline positions that have become solidified as the U.S. government weighs what could [...]