Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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Novartis‘ eye care business, Alcon, said today that it won FDA approval for its AcrySof IQ ReStor multifocal toric intraocular lens. The lens treats presbyopia and pre-existing corneal astigmatism in adult patients undergoing cataract surgery.
The AcrySof IQ ReStor intraocular lens is already commercially available in the E.U., Australia, Canada, parts of Central and South America and Asia. Read more
AtriCure in September warned doctors of the risk that the tip of its Cobra Fusion cardiac ablation catheter could dislodge and separate from the device.
The Cobra Fusion device is designed to deliver both bipolar and monopolar energy to the ablation site. The device also uses suction to gently pulls tissue out of the path of circulating blood to eliminate the heat sink effect during both modalities, according to AtriCure’s website. Read more
Cardinal Health said today it reached a settlement with the US Department of Justice, paying $44 million to clear up civil penalties related to a 2012 case with the US Drug Enforcement Agency.
With the settlement, the company said that all related governmental organizations “have agreed to take no further administrative or civil action on these and related matters.” Read more
The FDA announced it has relabelled Stryker subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II.
Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA. Read more
EnteroMedics said that its board declared a 1-for-70 reverse stock split effective Dec. 28, as part of the company’s plan to regain compliance with the NASDAQ exchange’s $1.00 minimum bid price.
ETRM shares closed at 49.2¢ apiece yesterday, down -0.8%. The stock was down another -1.2% today in pre-market trading to -48.6¢. Read more