Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH) stated that the Agency lacks sufficient power to block unsafe products. A new bill not endorsed by Shren, tabled by the House Democrats will allow FDA to reject devices based on predicates recalled for safety flaws.
Makers of the bill cite products – like the vaginal implants and hip replacements put out by New Brunswick (a Johnson & Johnson company). The arguement states that a product based on a device with similar design will inherit any flaws. Such was the case when the Agency approved vaginal mesh implants even though products with similar design were recalled by Boston Scientific Corp.
A settlement has been reached between the FDA and Globus Medical Inc with regards to the Distribution of NuBone Osteoinductive Bone Graft prior to reaching proper premarket approval.
Globus Medical Inc. alleged that it maintained “open communication” with FDA and believed that it was operating within the regulation.
David C. Paul the chairman and CEO of Globus Medical will pay $450K while Globus Medical is to pay $550K – which will total $1 Million.
Low patient volumes and pricing pressures will keep same-facility aggregate EBITDA growth in the low-single digits (percentage) for the next 12 to 18 months says Moody’s. This will impact device and manufactures who are expected to have EBITDA growth to hover around 1 to 4 percent through 2012.
As reimbursement pressures mount hospitals will continue to drive device prices lower. This comes at a time when device manufactures face challenges in getting reimbursement coverage.
Editor of The Health Care M&A Monthly and The Health Care M&A Report - Sanford Steever (PhD) was quoted as saying: “The only things that could slow it down are election-year jitters over the continued future of healthcare reform.”
The majority of members of the Royal College of Radiologists says NHS reforms should be abandoned. The college said 76% of its members – which include cancer specialists called for England’s NHS withdrawal of the plans to reform the health and social care bill.
Among the complaints for the bill, doctors say that the reforms are complex and not “fit for the purpose” and that it will cause privatization.
Royal College of Radiologists president Jane Barrett was quoted as saying: “The RCR has always had grave concerns about many aspects of the bill. We have sought, and, with others, attained many changes to the draft legislation. Despite those amendments, our concerns remain and we feel this move of position is necessary.” The reforms will mean an end to research and education and will impact integrated care.
Barrett went on to say: “Clinical radiology is at the hub of many areas of medical care, including cancer, stroke and trauma. Our clinical oncologist fellows and members are at the forefront in treating many cancers. It is essential that the Royal College of Radiologists continues to lead on the professional standards for the training and practice of clinical radiologists and clinical oncologists.”
Metal-on-metal hip replacements with head diameters of 36 mm or more need to be monitored every year of the life of the replacement says Medicines and Healthcare products Regulatory Agency (MHRA).
The updated advice was given to surgeons as a MHRA Medical Device Alert. which was issued to minimize the risk of complications.
Amendments to a law that will require all women having an abortion to get an ultrasound beforehand has been sent to Virginia’s Republican governor for approval. In addition to Virginia, six other states have similar laws.
The law will require the woman a chance to see an image of the child before an abortion. The will mandate that the image comprise the woman’s medical record for seven years.
House of Delegates approved the amendments on Thursday in a 61-35 vote. The amendments allows for an optional instrument to be used for determining the child’s age. Age determination is difficult during the first trimester and the probe (which is inserted in the woman’s vagina) will make this determination easier. Despite the “optional” requirement, women’s rights groups along with state Democrat lawmakers were upset – indicating that the procedure was too invasive.
Those in favor of the law say that the image will give women more information regarding their decision. North Carolina, Texas, and Oklahoma have requirements for a verbal description of the image to be provided to the woman, in addition to the ultrasound image.
An announcement was made – that Silverfleet Capital sold Sterigenics for $675 Million to equity group GTCR. The announcement said that the sale will close on the second quarter.
Sterigenics is the largest sterilization servicing firm. The company processes mainly single use medical devices and utilizes both Ethylene Oxide and Gamma sterilization methods. It has headquaters in Oakbrook Illinois.
Neil MacDougall – Silverfleet Managing Partner and Sterigenics Director,was quoted as saying that “(Sterigenics) has grown substantially during the six-year period that we have been investors.” He indicated that their success was attributed to investments in the creation of new service centers in Germany and China and capability expansions in the U.S., U.K., Belgium and France.
David Meyer -Sterigenics Chief Executive was quoted as saying that Silverfleet “fully understood both the opportunities and risks in our business and has, therefore, provided us with the assistance we needed, when we needed it.”
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