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After receiving a non-substantially equivalent letter from the FDA last month for its skin cholesterol test, Prevu, PreMD (Toronto) has now filed a request for a second level review of the 510(k) submission. "It's been devastating in terms of impact on the company," Brent Norton, president/CEO told Cardiovascular Devices & Drugs, later acknowledging that the decision puts the company in "a tough spot."
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England's influential National Institute for Health and Clinical Excellence (NICE) has reversed its earlier position opposing use of drug-eluting stents (DES), clearing the way for reimbursement of such interventions in what is estimated to be a $100 million market. If there are no appeals against the draft decision, the final guidance on DES will go into effect in March.
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Acacia Research; Acacia Patent Acquisition; Acrongenomics; Molecular Vision; Angiotech Pharmaceuticals; Symphony Medical; Boston Scientific; Getinge Group; Bristol-Myers Squibb; Bristol-Myers Squibb Medical Imaging; Micrus Endovascular; Genesis Medical Interventional; NewCardio; Marine Park Holdings; Synovis Life Technologies; Heraeus Vadnais
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As if a huge debt, a sagging share price, weakened sales and a variety of regulatory problems arent enough, a jury has ordered Boston Scientific (Natick, Massachusetts) to pay $431 million in damages to Dr. Bruce Saffran, a New Jersey radiologist who charged that the medical device maker's drug-eluting stents (DES) infringe a patent that he received in 1997.
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Amic; Arbor Surgical Technologies; Medtronic; CV Therapeutics; Medlogics Device; St. Jude Medical; HealthTrust Purchasing Group; Masimo
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General malaise is the only complaint of a 77-year-old man and, other than a low-grade fever, his vital signs are within normal limits. But while waiting to be seen, he becomes mildly disoriented, tachycardic, and hypotensive, and he is diagnosed with urosepsis. If the changes in this patient's status go unnoticed, he could suffer circulatory collapse.
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The next time an older person arrives in your ED with atypical or vague symptoms, an online resource could help you assess that patient.
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An elderly woman tells ED triage nurses she's had an excruciating, unrelenting headache for the past two days.
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If you assume that patients complaining of headache are nontherapeutic medication seekers or chronic complainers, you risk undertriaging these patients, warns Rebekah Child, RN, MSN, CEN, CNIV, an ED nurse at Cedars-Sinai Medical Center in Los Angeles.
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When guidelines for severe traumatic brain injury (TBI) are followed, deaths decrease by 50% and patients with poor outcomes decrease from 34% to 19%, according to a recent study.
