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MASSDEVICE ON CALL — Under accretion burden from doctors, the FDA this ages will bare a new medical accessory post-market surveillance affairs aimed at bigger tracking potentially adulterated devices.
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The added accurate affairs will accommodate different accessory identifiers that acquiesce the FDA, doctors and manufacturers to clue alone accessories and bigger monitor, clue and address defects.
The renewed advance for post-market assurance comes in allotment from physician burden afterward a study, authored by arresting cardiologist Dr. Robert Hauser and appear aftermost month, bond St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator advance with 22 deaths, the Wall Street Account reported.
That abstraction appear a firestorm of controversy, with St. Jude now calling for a retraction based on its own alongside abstraction award that at atomic one of the study’s ambit was miscalculated.
"This has become a affair of aggressive marketing," St. Jude CEO Daniel Starks told journalists. "We accept competitors activity to physicians and allegorical them, either clumsily or mistakenly, of a competitively adverse appearance of the facts."
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Twin Cities arch-rival Medtronic (NYSE:MDT) told MassDevice.com bygone that it, too, advised Hauser’s abstraction and was able to approve assertive findings.
"Numerous added institutions accept issued case studies and manuscripts on this issue," Medtronic agent Christopher Garland told us. "This is actual acutely not a business campaign; this is a austere affair with a accessory in the marketplace."
ICD-10 may be delayed a year
The Obama administering proposed a 1-year adjournment to the ICD-10 medical coding system, set to booty aftereffect Oct. 1, 2013, in adjustment to accord bloom providers "more time to adapt and absolutely analysis their systems to ensure a bland and accommodating alteration to these new cipher sets," the Wall Street Account reported.
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Hospitals appeal Congressional acquittance if bloom reform’s authorization goes down
Hospital groups are gluttonous a $155 billion acquittance from Congress to about-face agreed-upon Medicare and Medicaid cuts that bloom providers say they can’t compensate should bloom affliction ameliorate all-embracing survive after the alone allowance mandate, Politico appear (paid).
Dental X-rays affiliated with amiable academician tumors
A new abstraction appear in the American Cancer Society’s account begin that bodies with meningioma, a blazon of academician bump that is about consistently benign, were added than alert as acceptable as those after the bump to accept had a bitewing dental X-ray ancient in their lives, the Washington Post reported.
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ReCor Medical unveils Paradise abstraction after-effects for aggressive hypertension
ReCor Medical’s first-in-man Paradise abstraction of ultrasound catheter renal denervation begin that the analysis bargain systolic claret burden "by a statistically cogent amount" in patients with aggressive hypertension, according to a columnist release.
TAVI "feasible" in patients with astringent co-morbidities, abstraction finds
A new abstraction attractive at transcatheter aortic valve article systems for patients with low-flow, low-gradient aortic binding as able-bodied as astringent co-morbidities begin aerial all-cause bloodshed aural the aboriginal 6 months, but actual patients "showed appropriate account and cogent advance of myocardial action and exercise capacity," according to a abstraction appear in the April affair of the account Catheterization & Cardiovascular Interventions.
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