1. Articles from med-life.news

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    1. How a New Blood Volume Analyzer from Daxor Could Save Lives From Acute Heart Failure

      How a New Blood Volume Analyzer from Daxor Could Save Lives From Acute Heart Failure

      'The new technology is designed to quantify circulating total blood volume, plasma volume, and red cell volume with 98% accuracy — all through a simple, rapid blood test administered in both inpatient and outpatient settings.The test utilizes the indicator tracer dilution technique and is considered to be the gold standard for accuracy.'

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      Mentions: Jorg Lorscheider
    2. FDA Developing New Pathway for Device Clearance

      FDA Developing New Pathway for Device Clearance

      'Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old. 'That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies,' Gottlieb and Shuren added.

      To advance its goals, the agency is considering making public on its website a list of cleared devices that have demonstrated substantial equivalence to older predicate devices. It is considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies.

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      Mentions: Jorg Lorscheider
    3. FDA Eyes Changes to 510(k) Program

      FDA Eyes Changes to 510(k) Program

      'FDA wants to modernize the 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews.

      The agency said it is pursuing changes to the program in an effort to help keep pace with the increasing complexities of evolving medical technology. It’s important to note that the Center for Devices and Radiological Health (CDRH) cleared 3,173 medical devices through the 510(k) pathway in 2017, representing 82% of the total devices cleared or approved by FDA.'

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    4. Another EpiPen Is Now on the Market

      Another EpiPen Is Now on the Market

      'Teva Pharmaceuticals has finally launched its generic version of Mylan’s EpiPen.  The Petah, Tikvah, Israel-based company’s emergency allergy shot will be priced at $300 – the same as Mylan’s generic. Teva received approval for its version of EpiPen in August.

      The generic will be available in limited supply and the company will launch a lower-dose – the EpiPen Jr. sometime next year, the company said.

      “We’re pleased to provide access to Epinephrine Injection (Auto-Injector) for patients who may experience life-threatening allergic emergencies and we’re fully dedicated toward ensuring additional supply in 2019,” Brendan O’Grady, EVP'

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    5. Siemens Healthineers Unveils MAGNETOM Altea 1.5 Tesla MRI Scanner

      Siemens Healthineers Unveils MAGNETOM Altea 1.5 Tesla MRI Scanner

      The device features a generous 70 centimeter bore that will fit some of the largest patients, as well as the company’s BioMatrix technology that helps to prepare for scans based on patient info and speeds up the workflow. In part, this is done using a tool that alleviates the need for placing anatomical landmarks on the patient skin, instead using the skin itself as the marker.

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      Mentions: Jorg Lorscheider
    6. Abbott Nabs Approvals for DRG Invisible Trial System

      Abbott Nabs Approvals for DRG Invisible Trial System

      Abbott Laboratories has nabbed approvals for a chronic pain treatment device that patients can try before getting an implanted version of the technology. The Dorsal Root Ganglion (DRG) Invisible Trial System now has CE mark and a nod from FDA. The Abbott Park, IL-based company said patients who find adequate pain relief with DRG therapy can then have the Proclaim DRG System implanted.

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    7. Verily and Novartis Halt Glucose Detection Lens Work

      Verily and Novartis Halt Glucose Detection Lens Work

      The Mountain View, CA-based company isn’t out of diabetes completely, as it still has partnerships in the space with DexCom, Sensile, and Sanofi. “Our clinical work on the glucose-sensing lens demonstrated that there was insufficient consistency in our measurements of the correlation between tear glucose and blood glucose concentrations to support the requirements of a medical device,”

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    8. Mobidiag Receives Final €4M Tranche of €15M Financing Project

      Mobidiag Receives Final €4M Tranche of €15M Financing Project

      Mobidiag said in a statement that the funding has already enabled the company to finalize, launch, and commercialize its Novodiag molecular diagnostic system. The system is a fully automated PCR- and microarray-based instrument for small- to medium-sized clinical microbiology labs providing syndromic and targeted testing for infectious diseases..

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      Mentions: Jorg Lorscheider
    9. Chembio secures FDA EUA authorization for Ebola virus diagnostic test

      Chembio secures FDA EUA authorization for Ebola virus diagnostic test

      Point-of-care diagnostics firm Chembio Diagnostics has secured emergency use authorization from the US Food and Drug Administration (FDA) for its Ebola virus diagnostic test. Chembio said the EUA status has been provided for the DPP Ebola antigen system for use with human capillary fingerstick whole blood, EDTA venous whole blood and EDTA plasma.

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    1-24 of 538 1 2 3 4 ... 21 22 23 »
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