Latest Headlines

  1. Omron Introduces Smartwatch-Size Blood Pressure Monitor

    Omron Healthcare has miniaturized blood pressure monitor technology into a wearable device the size of a wristwatch, which can track blood pressure while monitoring physical activity and sleep.

  2. Precision Spine’s Anterior Cervical Interbody System Gains FDA Clearance

    Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has announced recently that it recently received 510(k) clearance of its ShurFit ACIF 2C Anterior Cervical Interbody System, which is made from medical grade polyetheretherketone (Peek Optima, LT1) and coated with both commercially pure Titanium (Ti) and Hydroxyapatite (HA).

  3. NICE Pauses Plans To Charge Manufacturers For Medical Device Appraisals

    The U.K.’s National Institute of Health and Care Excellence’s (NICE) plan to recoup the appraisal cost of drugs, devices, and diagnostics by charging industry has been temporarily suspended.

  4. FDA Describes How Interface Design And Human Factors Support Approval Of Generic Combination Products

    The US Food and Drug Administration (FDA) has issued a draft guidance to assist submitters of abbreviated new drug applications (ANDA) in minimizing differences between the user interface of a proposed generic drug-device combination product and the user interface of its Reference Listed Drug (RLD).

  5. Abbott's DRG Neurostimulation System Launches In EU

    Abbott (NYSE: ABT) today announced the European launch of the new Proclaim™ DRG Neurostimulation System, designed to deliver dorsal root ganglion (DRG) stimulation to patients suffering from chronic neuropathic pain. Through the Proclaim platform's Bluetooth® wireless technology and iOS™ software, the Proclaim DRG Neurostimulation System offers patients a more intuitive therapy experience, compared to current systems with traditional controllers that can be difficult to operate.

  6. MKS' Ophir® Business Unit Honored as Manufacturer of the Year by Utah Manufacturers Association

    MKS Instruments, Inc. recently announced that the Utah Manufacturers Association has honored the Ophir Business Unit, part of the Light and Motion Division of MKS Instruments, as 2016 Utah Manufacturer of the Year for "Outstanding Performance in Operational Excellence, Economic Achievement, Workplace Safety, Community Outreach, and Fidelity to the Principles of Free Enterprise."

  7. Siemens Healthineers, Biogen To Jointly Develop MRI Tools For MS

    Siemens Healthineersand Biogen have announced that the companies plan to jointly develop magnetic resonance imaging (MRI) applications with the intent of quantifying key markers of multiple sclerosis (MS) disease activity and progression.

  8. When Is An Investigational Device Ready For Human Study? FDA Weighs In

    FDA has finalized a guidance outlining risk-benefit factors manufacturers should consider when determining whether an investigational device is suitable for clinical study with human participants. 

  9. FDA Explains How To Prepare Pre-Request For Designation Submissions

    The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing how device sponsors should prepare and submit Pre-Request For Designation (Pre-RFD) submissions to seek early input from the agency during a combination product's early stage of development, when the sponsor is contemplating a specific configuration of the product.

  10. CyMedica Orthopedics® Announces FDA Clearance For e-vive™, The First App-Driven Muscle Activation Therapy And Patient Engagement Solution For Pre And Post-Operative Knee Surgery Rehabilitation

    CyMedica Orthopedics®, developer and manufacturer of innovative muscle rehabilitation systems announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for e-vive™- the first of its kind app-controlled, data-driven muscle activation therapy and patient engagement solution designed to empower at-home pre-hab to rehab muscle strengthening for ACL and total knee replacement patients.