Regulatory: Page 116

MiE, NIS get FDA OK for PET upgrade
By AuntMinnie.com staff writers
Medical Imaging Electronics (MiE) and Nuclear Imaging Services (NIS) have received 510(k) clearance from the U.S. Food and Drug Administration for its ECAT Scintron upgrade.
May 15, 2013
FDA clears Bayer's Xofigo
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared the use of radium-223 dichloride to treat patients who have castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.
May 15, 2013
iCRco gets clearance for CR mammo
By AuntMinnie.com staff writers
Computed radiography (CR) firm iCRco has received clearance from the U.S. Food and Drug Administration for its 3600M mammography system.
May 13, 2013
FDA issues report on medical device ID plans
By AuntMinnie.com staff writers
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has published a report providing an update of its plans to require that most medical devices distributed in the U.S. carry a unique device identifier.
May 12, 2013
California's breast density notification law -- 1 month in
By Kate Madden Yee
It's been just over 30 days since California's version of breast density notification legislation went into effect. How is the law affecting clinical practice in the state's breast centers? Although they are complying, many breast imagers are skeptical of its value.
May 8, 2013
2013 05 06 10 55 22 338 Breast Density 200
Signostics gets FDA nod for handheld US device
By AuntMinnie.com staff writers
Australian handheld ultrasound developer Signostics has received U.S. Food and Drug Administration 510(k) clearance for its Signos RT ultrasound system.
May 6, 2013
NJ legislation would require breast density payments
By AuntMinnie.com staff writers
Legislation is advancing in the New Jersey Assembly that would require health insurers to cover additional breast screenings if a mammogram demonstrates dense breast tissue, according to a bill by sponsor Troy Singleton (D-Burlington).
May 6, 2013
Siemens gets FDA clearance for MRI software
By AuntMinnie.com staff writers
Siemens Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration for its CAIPIRINHA software, which cuts by half the length of time patients need to hold their breath during MRI scans.
May 5, 2013
2013 05 08 12 36 29 161 Siemens Caipirinha B 450
CMS proposes 2014 inpatient payment rates
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule for 2014 payment rates of hospital-provided inpatient services.
April 28, 2013
Teleflex gets nod from FDA
By AuntMinnie.com staff writers
Medical device developer Teleflex announced that its Arrow VPS G4 device for catheter line placement has received 510(k) clearance from the U.S. Food and Drug Administration.
April 28, 2013
NinePoint gets new clearance for esophageal system
By AuntMinnie.com staff writers
NinePoint Medical said it has received an additional 510(k) clearance from the U.S. Food and Drug Administration for its NvisionVLE optical coherence tomography imaging system.
April 28, 2013
U.S. House passes bill to protect helium supply
By AuntMinnie.com staff writers
A bipartisan bill to prevent the early closure of the Federal Helium Reserve has passed the U.S. House of Representatives by a vote of 394 to 1, according to the Medical Imaging and Technology Alliance.
April 25, 2013
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