BEDFORD, Mass., Dec. 15, 2011 /PRNewswire/ — Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved its Cervista HTA (high [...]

The FDA has issued a Class I Recall for Mizuho Orthopedic Systems’ OSI Modular Table Systems. The incorrect removal of T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor. http://www.fdanews.com/newsletter/article?issueId=15257&articleId=141718

Shares of CardioNet Inc. plunged Wednesday after the heart device maker said the U.S. Department of Justice is investigating allegations CardioNet may have overcharged Medicare. THE SPARK: CardioNet disclosed Tuesday that it received a civil investigative demand from the Justice Department. According to the company, the agency said it is looking into allegations CardioNet used [...]

Not every electrical device can keep going and going. Take Medtronic’s SynchroMed II Implantable Drug Infusion Pump, for example. The batteries that power the implanted drug delivery device have been reported to fail, Medtronic announced Friday, though such occurrences are rare. The company said it first warned physicians of the battery problem in 2009. By the [...]

Abbott (NYSE:ABT – News) today announced it has received U.S. Food and Drug Administration (FDA) approval for the XIENCE nano™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease in small vessels. XIENCE nano, which is based on the same platform as the XIENCE V® Everolimus Eluting Coronary Stent System, offers physicians [...]

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, today announced the approval of the EXOSEAL™ Vascular Closure Device in the US. EXOSEAL™ incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure.   ”We are very pleased to announce [...]

The FDA warns a trio of companies that offer direct-to-consumer genetic tests on medical claims made in their marketing campaigns. The FDA formally warned three providers of direct-to-consumer DNA tests about medical claims the companies make that the federal watchdog agency hasn’t approved. The FDA wants the companies; American International Biotechnology Services, Lumigenix Inc and [...]

Boston Business Journal — Boston Scientific Corp. (NYSE: BSX) has announced that a shipment of medical devices was stolen last month on its way to the company’s sterilization facility. The Natick, Mass.-based medical device company said that the devices, which include endoscopy and urology/women’s health devices, could cause infection, since they were not yet sterilized. [...]

Reminding your bones to grow…Smith & Nephew has announced a new, free service that helps patients keep on track with their physician-prescribed EXOGEN Ultrasound Bone Healing System treatment plans. Via EXOGEN CONNECTS, patients can receive reminders and tips for healthy living. Those who enroll in EXOGEN CONNECTS have on hand a personal wellness and support [...]

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that its DuraSeal(TM) Exact spine sealant has been approved by the U.S. Food and Drug Administration (FDA). DuraSeal Exact spine sealant is a new, low-swell formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The [...]