MASSDEVICE ON CALL — Med-tech industry lobby AdvaMed had some words of inspiration for lawmakers looking to mark up the latest iteration of the Medical Device User Fee Act this week.
"Mark up is an important milestone in the reauthorization process, and we are encouraged by the bipartisan support this legislation has received," AdvaMed chairman & CEO Stephen Ubl said in a prepared statement. "We are hopeful it will remain on track to pass in a timely fashion."
The device advocate was an instrumental player in drafting the new user fee deal, which will effectively double the fees the FDA can collect for medical device review in exchange for meeting certain performance goals.
New AdvaMed chairman and Zimmer (NYSE:ZMH) president & CEO David Dvorak named passage of the latest user fee agreement as 1 of the top priorities of his 2-year term.
Medicare bust by 2024?
Medicare trustees warned Congress this week that the program’s hospital trust fund will be broke by 2024, Healthwatch reported.
Roche launches Class I recall of heart attack diagnostics
Roche’s (PINK:RHHBY) recall of a series of Elecsys Troponin I and Elecsys Troponin I STAT immunoassays, used to determine heart damage as an aid in the diagnosis of a heart attack, over concerns that they may return a falsely low result that "may cause serious adverse health consequences, including death," according to an FDA report.
New PET/CT scans look for infections around implants
Doctors can distinguish between normal post-operative inflammation and an active infection around a medical implant using combined fluorodeoxyglucose marked by fluorine-18 positron-emission tomography and computed tomography, TheHeart.org reported.
New cell phone scanner looks for oral cancer
OScan, maker of a smartphone attachment capable of diagnosing oral cancer using high-res imaging scans of the mouth, won the 2012 mHealth Alliance Award, iMedicalApps.com reported.