Medtronic, Inc. announced that it has received FDA approval for the world's first insulin pump with real-time continuous glucose monitoring . The Minimed Paradigm will help patients take immediate action to correct or prevent problems related to glucose level.
This morning's New York Times has an extensive article on the new wave of genomic-based diagnostic tests. The new territories they can explore in diagnostics are exhilarating, and their profit margins are far more than those for conventional tests. But concerns remain about whether the extra cost is justified, and FDA is interested in expanding its regulatory oversight. Traditionally, FDA has regulated tests sold to doctors and hospitals but not those done by a single lab.
Only one hurdle remains for the largest deal in device-industry history to go through. European Union regulators have approved Boston Scientific Corp.'s $27 billion purchase of Guidant Corp. They also signed off on the sale of Guidant's stent business to Abbott. All that's needed now is approval from the U.S. Federal Trade Commission, which is expected to come shortly. Then the real work can begin. And there is a lot of work to be done to get back in the graces of FDA and the public.
FDA and the Centers for Disease Control and Prevention have sent out a public health notice warning of increasing reports of a serious fungal infection caused by soft contact lenses that if untreated can lead to blindness. As of Sunday, 109 cases of the fungal infection, known as keratitisÂ andÂ linked to the fungusÂ Fusarium , were under investigation.
Some believe that external defibrillators aren't in more public places because of fear of lawsuits over misuse. That fear may be alleviated in Canada's largest province. The Ontario legislature is considering a bill that would protect any individual who uses one from liability.
CDRH has used outside experts to help it review products during the approval process. But it has never used them for help on postmarket issues until now. The New York Times reports that CDRH will expand an existing advisory panel for heart devices to add experts who will advise it on postmarket safety issues for those products. They will help CDRH interpret safety data that comes in and advise it on how to handle seriousÂ issues like recalls.
FDA has awarded a contract to Booz Allen Hamilton to evaluate the postmarket study commitment process. The hoped-for outcome is greater consistency among the centers for requiring, requesting, facilitating and reviewing postmarket study commitments. The evaluation is expected to begin this month and should last about a year.
On April 3, Congress requested that the U.S. International Trade Commission investigate the effects of foreign market competition on U.S. medical device and equipment trade. ITC will examine regulatory and other conditions of competition that affect sales and trade of U.S. medical devices in Japan and other foreign markets.
After two years of a healthy market for Initial Public Offerings, things slowed down in the first quarter of 2006. A poll by Thomson Venture Economics and the National Venture Capital Association showed that there were only 10 IPOs in the quarter, totalling $540.8 million. That puts 2006 well behind pace to match the 56 IPOs that fetched $4.46 billion in 2005. Of the 10 IPOs, three were in the "Medical/Health" category, but it's not specified how many of those are device companies.
Boston Scientific's $27 billion purchase of Guidant Corp. was ratified by shareholders of both companies Friday, with 98% of Guidant shareholders and 96% of Boston Scientific's backing the plan. The deal will take effect upon U.S. and European Union regulatory approval, expected some time this month. If you've been reading this blog, you know about the mess Guidant has gotten itself into in the past year. Can Boston Scientific clean it up? We'll see.
Starkey Laboratories of Eden Prairie, MN has a new hearing aid debuting this week. It purports to automatically adapt to the environment, enhancing sounds users want to hear and cutting down background noise. The company predicts that the device will revolutionize hearing aids and produce sales of 1 million units annually. The Minneapolis Star-Tribune is similarly enthusiastic, judging from an article it ran this morning.
MD&DI Associate Editor Maria Fontanazza just returned from the Medical Device Regulatory and Compliance Conference at Harvard University. Here is her report: As the pace of medical innovation continues to accelerate, expect some changes from CDRH in the coming months. Scott Gottlieb, deputy commissioner for medical and scientific affairs in the Office of the Commissioner at FDA, saidÂ the agencyÂ is ready to tackle regulatory, product, and communication challenges. And with the cost of healthcare increasing, FDA needs to take steps to develop a more efficient approach, said Gottlieb.
Guidant Corp. suffered yet another setback yesterday when it announced it would scrap its drug-eluting stent slated for introduction in Europe because of manufacturing defects. The New York Times reports that European introduction of the Xience V stent has been pushed back to the third quarter of this year, and the company has taken a $15 million write-off for the first quarter.
In the latest chapter of the battle over stent technology, Medtronic Inc. has sued Guidant Corp., alleging two of Guidant's stents infringe patents licensed to Medtronic. The suit , filed in the High Court in Dublin, Ireland, follows a similar action filed in North Carolina in February. evYsio Medical Devices, the Canadian company Medtronic licensed its technology from, has two separate suits against Guidant pending.
CDRH's Office of Science and Engineering Laboratories (OSEL) today released its annual report for Fiscal Year 2005 . OSEL supports the scientific basis for FDAâ€™s regulatory decision-making by developing independent laboratory information for CDRH. In addition, OSEL researchers are involved in mission-oriented science activities including test methods development, risk assessments, forensic investigations, product evaluations, and technology forecasting.