The FDA has approved the cobas HPV (human papillomavirus) test from Roche (Basel, Switzerland) as a first-line primary screening test for cervical cancer in women 25 and older. The approval follows the March 12 unanimous recommendation from the Microbiology Devices Panel of the FDA's Medical Devices Advisory Committee, making the cobas the only HPV test in the U.S. approved for first-line primary screening. Previously HPV tests had been used as a follow-up test for Pap (Papanicolaou) results and as an adjunct to Pap in women over 30.
In a multi-billion deal that would combine two major orthopedic players, Zimmer (Warsaw, Indiana) said Thursday it will acquire Biomet (also Warsaw) for $13.35 billion in cash and stock. The transaction is expected to close in the first quarter of 2015.
When patients receive an implantable cardioverter-defibrillator (ICD) system, there's a good chance they will need an MRI scan within 10 years of receiving the device. The problem is that in the U.S. there are no ICD devices approved for MR-conditional use because of potential interactions between the MRI, the ICD, and patient safety.
A Federal District Court judge took med-tech investors and spectators by surprise earlier this month by ordering a preliminary injunction on the U.S. sales of Medtronic's (Minneapolis) CoreValve transcatheter aortic valve replacement (TAVR/TAVI) system. The case took a turn in Medtronic's favor this week as the Federal Circuit Court of Appeals granted the company's request to postpone the implementation of the injunction.
A torn anterior cruciate ligament (ACL) is almost like the classic chicken and egg problem. Most people who tear their ACL enjoy playing sports and in fact playing sports is usually how they tear their ACL to begin with. But once they tear their ACL they cannot return to sports until the ligament is repaired.
Gastroenterologists are usually quick to admit they do not have a good way to manage patients with Barrett's esophagus. They know Barrett's is a precursor to esophageal cancer, but they don't have a great way of predicting which Barrett's patients are likely to progress to esophageal cancer and which patients probably won't develop the cancer.
TriVascular Technologies (Santa Rosa, California), a company pursuing technologies to treat aortic abdominal aneurysms (AAA) raised $78 million in its Wall Street debut Wednesday on the Nasdaq Global Select Market. The company launched its initial public offering of 6.5 million shares of common stock priced at $12 a share, below the previously expected range of $13 to $15.