By Kelly A. Briganti, Editorial Director, G2 Intelligence
Starting April 15, the FDA will begin implementing an expedited approval process for devices subject to premarket approval or de novo requests that can satisfy unmet needs for life-threatening or irreversibly debilitating conditions. Participation in this Expedited Access Pathway (EAP) program, is voluntary at the sponsor's request. Jeffrey Shuren, M.D., J.D., Director of the U.S. Food and Drug Administration's Center for Devices and Radiological Health, explains the reason behind the EAP in an April FDA Voice blog: "We know that…
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By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Many current commercial electronic health records (EHRs) have "significant limitations" in graphing laboratory test results, according to a study published online March 19 in the Journal of the American Medical Informatics Association. The authors say that nonstandardized display of results has patient safety implications if test data is not communicated clearly and accurately.
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By Stephanie Murg, Managing Director, G2 Intelligence
Although an extensive body of research links inherited mutations in the BRCA1 and BRCA2 genes to breast and ovarian cancer, little is known about the relationship between specific mutations and cancer risk—until now. A study published in the April 7 issue of the Journal of the American Medical Association identified mutations that are associated with significantly different risks of breast and ovarian cancers.
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By Ron Shinkman, Editor, Laboratory Industry Report
Foundation Medicine and pharmaceutical giant Roche have closed their $1.03 billion strategic transaction, the two companies have announced this week.
Under the terms of the deal, Roche has purchased 15.6 million shares from the Massachusetts-based Foundation at the price of $50 per share. Roche also purchased another 5 million shares newly issued by Foundation, for gross proceeds of $250 million. The company also was granted three new seats on the now eight-member board of directors.
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By Christopher P. Young, Editor, G2 Compliance Advisor
Brookline Massachusetts physician, Dr. Punyamurtula Kishore, and his company Preventive Medicine Associates, Inc. (PMA), pleaded guilty to fraudulently billing Massachusetts's Medicaid program, MassHealth, for unnecessary drug tests. Kishore was sentenced to 11 months in jail and he and PMA were ordered to pay $9.3 million after pleading guilty to Medicaid kickbacks, Medicaid false claims (for PMA) and larceny over $250 (for PMA and Kishore). Kishore also agreed to surrender his medical license.
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