Guided Therapeutics Announces Plans for Advancing PMA Application August 18, 2015 Company plans to collect additional scans to supplement data already provided to FDA. Read More
CareFusion Recalls Over 7,000 Units of Alaris Syringe Pump August 18, 2015 Recall Is CareFusion’s Ninth Class 1 Recall of an Alaris Device Since 2010. Read More
Cohera Medical Receives Approval to Market Surgical Sealant in EU August 17, 2015 Sealant is designed to reduce leaks after gastrointestinal procedures during the first few days of healing. Read More
Nonin Medical Introduces Wireless Finger Pulse Oximeter August 17, 2015 Device enables clinicians and patients to monitor arterial blood oxygen saturation and pulse rate. Read More
New MRI Contrast Agent Detects Smaller Aggressive Tumors August 17, 2015 Agent can detect tumors as small as 300 microns. Read More
FDA Clears GE Healthcare for Low Dose CT Lung Cancer Screening Option August 17, 2015 GE Healthcare first to receive FDA clearance for low dose CT lung cancer screening option. Read More
Cadence Biomedical Collaborators Secure Grant for Neurorehabilitation Device August 17, 2015 Grant awarded by the Physiotherapy Foundation of Canada and the Quebec Rehabilitation Research Network. Read More
Washington Hospital Implants Cochlear’s Thinnest Implant August 14, 2015 The thin design means the device is less noticeable. Read More
Provista Recruits Women for Breast Cancer Blood Test August 14, 2015 The company uses an algorithm to determine if the test can differentiate malignant and benign tumors. Read More
Integrity Applications Submits Presubmission Documents to FDA for GlucoTrack DF-F August 14, 2015 The company is seeking FDA guidance on the regulatory pathway for the device. Read More
Integra LifeSciences Completes Purchase of TEI Businesses August 14, 2015 The deal expands Integra’s reconstructive surgery and wound care product lines. Read More
Roche Snaps Up Molecular Diagnostics Maker GeneWEAVE BioSciences August 14, 2015 GeneWEAVE’s first system is being evaluated in a U.S. clinical trial. Read More