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FDA Approves SBi's S.T.A.R.(R) Total Ankle Replacement System
Small Bone Innovations, Inc. (SBi), a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced that the U.S. Food and Drug Administration (FDA) has approved SBi"s Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients. S.T.A.R. has received pre-market approval (PMA) to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.

New Animal Study Of Rexahn's Serdaxin™ Shows Drug's Promise To Treat Anxiety And Depression With Minimal Side Effects
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), announced the results of a wide-ranging animal study offering more evidence that Serdaxin™ may be an effective therapeutic for the treatment of anxiety disorders in humans. Serdaxin is Rexahn"s leading anxiety and depression drug candidate, and is currently in Phase II clinical trials.
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New York Times Examines Changes In Surrogacy Process In Recent Years
The medical, legal and interpersonal processes involved with a surrogate birth have changed significantly since the controversial "Baby M" case two decades ago, the New York Times reports. In the case, the surrogate was the infant"s biological mother and unsuccessfully sought custody of the child after birth. The Times reports that the legal proceedings in the case helped reinforce the validity of surrogacy contracts, which are now standard practice.Most couples today use a gestational surrogate -- meaning that they have no genetic link to the woman carrying the fetus -- and some choose to maintain friendships with the surrogate after birth. According to the Times, people might choose gestational surrogacy if the woman lacks a uterus, has a malformed uterus, must take medication incompatible with pregnancy, or has had repeated miscarriages or failures at in vitro pregnancies. Male couples or single men might also use this option.Legal protections have strengthened since the Baby M case, although surrogacy remains illegal in some states. State laws also vary in the steps required to ensure that the parents" names, rather than the surrogate"s, are on the child"s birth certificate.Despite an increase in popularity, surrogacy remains "fraught with controversy" over criticisms that compensation to surrogates amounts to "baby selling" and exploitation of low-income women, according to the Times. However, surrogacy advocates say that most women who choose to become surrogates have altruistic motives. Surrogates typically receive between $15,000 and $20,000 as compensation for carrying the pregnancy and undergoing hormonal preparations. The Times reports that reputable agencies and lawyers who specialize in surrogacy help guard against exploitation and spurious motives for seeking a surrogate pregnancy. Prospective surrogates and parents typically undergo psychological screening and legal guidance, and most lawyers require that surrogates meet certain age and health criteria (Brody, New York Times, 7/21).
Nutrition

Care Regulator Publishes Inspection Report On East-Yorkshire Based Mental Health Hospital

The Care Quality Commission (CQC) has published an inspection report on the Yorkshire-based independent mental health hospital, Linden House in Market Weighton near York. The report says improvements have been made in relation to concerns about the quality of care following an unannounced inspection in March. But the Commission makes clear that further significant progress is required. Inspectors assessed the low- and medium-secure hospital against statutory requirements made last year. As a result, Linden House now faces further enforcement action over breach of the Private and Voluntary Health Care Regulations (2001). CQC"s predecessor the Healthcare Commission had found in September and December last year that Linden House had not met requirements relating to issues such as handling controlled drugs, handling confidential information, staff training, staff levels and the adequate risk assessment of patients. It consequently issued four statutory notices, warning the provider of potential legal action if it failed to comply. At the follow up inspection in March, CQC found significant improvements had been made at Linden House in staffing levels at the hospital. Assessors felt this had had a positive impact on patients and nursing staff. But the Commission found that the hospital had still not met all of the requirements detailed previously. Concerns included: - There was no evidence of any suicide/self harm audits being completed within the hospital. - There was no evidence that any supportive observation audits had been completed. - Information for patients was not available for them in accessible formats. - Not all staff receive annual appraisals. - No evidence of current Nursing and Midwifery Council registration status for all staff required to be registered. - Information on how to make a complaint not available in an accessible format for all of the patients. CQC has now issued a further two statutory notices, taking the total served on the hospital up to six. Tim Weller, the Commission"s senior enforcement manager, said; "We welcome the positive action that has taken place at Linden House but much more needs to be done. "We are absolutely determined to make sure that the company takes the right action on behalf of patients. "We are currently considering what further enforcement action needs to be taken to ensure compliance and will continue to closely monitor the situation at the hospital." The CQC"s powers include prosecution and/or cancelling registration of a provider that fails to comply with enforcement notices. Linden House is registered under the Care Standards Act 2000 to provide services for patients with a learning disability or for people who have been detained under the Mental Health Act. Read the latest inspection report for Linden House The Care Quality Commission


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