By a News Reporter-Staff News Editor at Health& Medicine Week Masimo announced that its rainbow Acoustic Monitoring? sensor, RAS-125c Acoustic Respiration Cloth Sensor has received U.S. FDA 510 clearance for continuous, noninvasive monitoring of acoustic respiration rate in pediatric patients. Masimo rainbow Acoustic Monitoring noninvasively an
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 23, 2013.{ nfg} Omeros Corporation announced its Investigational New Drug Application to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next
Perosphere Inc. said that it has received U.S. Food and Drug Administration Investigational New Drug clearance to initiate clinical investigations of the safety and efficacy of PER977 to reverse the anticoagulant activity of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors. Daiichi Sankyo Compan
Celgene International Srl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE^ in combination with gemcitabine for the first line treatment of patients with advanced pancreatic cancer.
BOUDRY, Switzerland Celgene International Srl, a subsidiary of Celgene Corporation today announced that the U.S. Food and Drug Administration has assigned a Priority Review designation to the supplemental New Drug Application for the use of ABRAXANE in combination with gemcitabine for the first line treatment of patients with advanced p
Covidien, a global provider of healthcare, announced that its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration 510 clearance for motion claims. According to a release, this makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside puls
WASHINGTON The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. The FDA said Roche's test is the first to be approved to diagnose the disease. "Providing health care professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appr
The U.S. Food and Drug Administration approved 12 new molecular entities in the first quarter of 2013. Fitch expects cancer drugs to lead specialty drug authorizations again in 2013, but new diabetes treatments could be a close second. Fitch notes that the FDA has instituted a new program- breakthrough therapy designation- to expedite the drug appr
SEATTLE, May 23, 2013/ PRNewswire/ Omeros Corporation today announced that its Investigational New Drug Application to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this
Omeros Corporation today announced that its Investigational New Drug Application to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this year, the OMS824 IND for use in pati
ENP Newswire- 22 May 2013. Release date- 21052013- ALISO VIEJO, CA.- Bausch+ Lomb, the global eye health company, today announced that it is has received approval from the U.S. Food and Drug Administration for the TRULIGN Toric posterior chamber intraocular lens. Jay Pepose, M.D., Ph.D, of the Pepose Vision Institute in St. Louis, MO, and medical m
Direct Flow Medical, Inc., a transcatheter heart valve company focused on improving patient outcomes, announced that it has received approval from the United States Food and Drug Administration for an Investigational Device Exemption to begin the SALUS feasibility trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System.
Perosphere Inc. announced today that it has received U.S. Food and Drug Administration Investigational New Drug clearance to initiate clinical investigations of the safety and efficacy of PER977 to reverse the anticoagulant activity of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors.
Varian Medical Systems today announced it received 510 clearance from the U.S. Food and Drug Administration for Varian's diagnostic X-ray image processing workstation that combines radio frequency and digital radiography capabilities on one platform. Varian's Nexus DRF Digital X-Ray Imaging System? has the ability to interface with a variety of i
ALISO VIEJO, Calif., May 21, 2013/ PRNewswire/ Bausch+ Lomb, the global eye health company, today announced that it is has received approval from the U.S. Food and Drug Administration for the TRULIGN? Toric posterior chamber intraocular lens. Jay Pepose, M.D., Ph.D, of the Pepose Vision Institute in St. Louis, MO, and medical monitor of the FDA
A new study from MIT analyzes the potential usefulness of a new treatment that combines the benefits of angioplasty balloons and drug-releasing stents, but may pose fewer risks. While approved for limited use in Europe, these drug-coated balloons are still in development in the United States and have not received FDA approval. The MIT study, which
Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration approved the use of Hologic' s new C-View 2 D imaging software. C-View 2 D images may now be used i
May 21 A Tennessee pharmacist pleaded guilty Tuesday in federal court in Topeka to substituting a cheaper drug imported from China for kidney dialysis patients in Kansas. Although there were no reports of harm to patients, the crime put patients at risk because the FDA cannot assure the safety and effectiveness of products that are not FDA approv
Hologic, a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration approved the use of Hologic's new C-View 2 D imaging software. C-View 2 D images may now be used in place
Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced that its Nellcor? pulse oximetry portfolio, which is used to measure arterial oxygen saturation, has received U.S. Food and Drug Administration 510 clearance for motion claims. This makes Covidien
By a News Reporter-Staff News Editor at Pharma Business Week BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced that the Food and Drug Administration granted approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator series. The Ilesto devices exemplify the...
By a News Reporter-Staff News Editor at Pharma Business Week "A significant percentage of patients are unable to lower their LDL cholesterol to recommended levels despite treatment," said Peter H. Jones, M.D., associate professor of medicine, Baylor College of Medicine. "Along with a healthy diet, LIPTRUZET is an effective new lipid-lowering tre
By a News Reporter-Staff News Editor at Pharma Business Week Sedasys, a Division of Ethicon Endo-Surgery, Inc., announced that the U.S. Food and Drug Administration has granted PMA approval for the SEDASYS System, the first computer-assisted personalized sedation system. The SEDASYS System is indicated for the intravenous administration of 1% pro
The U.S. Food and Drug Administration approved 12 new molecular entities in the first quarter of 2013. Fitch expects cancer drugs to lead specialty drug authorizations again in 2013, but new diabetes treatments could be a close second. Fitch notes that the FDA has instituted a new program- breakthrough therapy designation- to expedite the drug appr
By a News Reporter-Staff News Editor at Pharma Business Week Hill-Rom Holdings, Inc., a global leader in healthcare technologies, announced that it has received 510 clearance from the U.S. Food and Drug Administration to market the MetaNeb 4.0 System, the company's latest advancement in airway clearance technology for enhanced patient care in the
