Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
In an apparent effort to push back against medical device industry lobbying, the FDA crafted an internal report outlining agency successes in keeping "malfunctioning or needlessly invasive high-risk medical devices" off the U.S. market, despite their approval in the European Union.
The U.S. Senate’s Health, Education, Labor & Pensions Committee passes the "Food & Drug Administration Safety and Innovation Act," but fails to include provisions consumer advocates insist are necessary to protect patients from unsafe medical devices.
Accuray will go head-to-head against Intuitive Surgical in a first-of-its-kind clinical study comparing its CyberKnife radiosurgery system against the da Vinci surgical robot in efforts to establish a new gold standard for early-stage prostate cancer.
Wall Street analysts remain confident that Boston Scientific subsidiary Cameron Health’s lead-free implantable cardioverter defibrillator will win FDA approval this week, but some wonder whether the device will appeal to patients.
An FDA advisory panel recommended approval for HeartWare International‘s (NSDQ:HTWR) HVAD implantable heart pump for people with end-stage heart failure, a decision that may be good news for rival heart makers Abiomed (NSDQ:ABMD) and Thoratec (NSDQ:THOR) as well.
Opponents of the impending 2.3% medical device levy appear to be gaining steam as an increasing number of outlets are reporting on repeal efforts and the measure’s potential to hurt jobs and innovation.
Med-tech titan Boston Scientific issues a warning on electrical malfunctions in its Cognis and Teligen implantable cardioverter defibrillators, after receiving reports of a small number of adverse events including 1 patient’s death.