Latest Headlines

  1. Quantitative Insights’ QuantX Advanced Computer-Aided Diagnosis Platform Earns FDA De Novo Approval

    Quantitative Insights, Inc. (QI) recently announced that it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantX Advanced system, the industry’s first computer-aided diagnosis platform incorporating machine learning for the evaluation of breast abnormalities.

  2. Outsourced Pharma Announces San Diego Conference Session Update

    Outsourced Pharma announces an agenda and panelist update for its Outsourced Pharma San Diego conference to be held in La Jolla on August 22 – 23 2017, at the Hyatt Regency La Jolla. Outsourced Pharma is a conference designed for executives at pharma and biotech sponsor companies who rely on contract development and manufacturing organizations to bring their products to market.

  3. FDA Clears First Neonatal Magnetic Resonance Imaging Device

    Recently, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).

  4. Life Science Connect Announces The Acquisition Of Industry Standard Research

    Today Life Science Connect (LSC), a leading B2B marketing services and engagement company, announced the acquisition of Industry Standard Research (ISR), also known as ISR Reports.

  5. FDA Clears Philips’ Wearable Light Therapy Device For Psoriasis

    Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Philips BlueControl wearable light therapy device to treat mild psoriasis.

  6. Abbott, Bigfoot Biomedical To Collaborate On Diabetes Technologies

    Abbott (NYSE: ABT) and Bigfoot Biomedical today announced that the companies have entered into an agreement to develop and commercialize diabetes management systems, integrating Abbott's FreeStyle® Libre glucose sensing technologyi with Bigfoot's insulin delivery solutions in the United States.

  7. Stryker’s MultiGen 2 RF Generator Cleared BY FDA

    Stryker announced today that it has received FDA 510(k) clearance for its MultiGen 2 RF Generator. This product provides physicians with the efficiency, control and reliability they need when performing radiofrequency ablation, a minimally invasive procedure that can provide lasting relief to those suffering from facet joint pain.1

  8. Zimmer Biomet CEO Dvorak Steps Down

    Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced that David C. Dvorak has stepped down as President and Chief Executive Officer and a member of the Board of Directors, effective today.

  9. FDA Approves Medtronic’s CoreValve Evolut TAVR For Expanded Indication

    Medtronic plc recently announced the expanded U.S. Food and Drug Administration (FDA) approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.

  10. Masimo’s rainbow Super DCI-Mini Sensor Earns CE Mark

    Masimo announced recently the CE marking of the rainbow Super DCI-mini sensor, a reusable spot-check sensor that features Masimo SET Measure-through Motion and Low Perfusion pulse oximetry and rainbow SET technology with multiple physiologic measurements – including, for the first time, the ability to measure total hemoblogin (SpHb), carboxyhemoglobin (SpCO), methemoglobin (SpMet), and arterial oxygen saturation (SpO2) using the same noninvasive reusable sensor.