World’s Smallest Pacemaker Wins CE Mark Approval for Medtronic April 15, 2015 The device is one-tenth the size of most pacemakers. Read More
DBV Technologies’ Peanut Allergy Treatment Wins FDA Breakthrough Therapy Designation April 13, 2015 Viaskin Peanut is the first food allergen treatment to receive the designation. Read More
FDA to Balance Premarket, Postmarket Data Requests April 10, 2015 A new final guidance from the U.S. FDA explains when the agency might let safety or performance information be gathered after PMA approval. Read More
FDA Issues Final Guidance on Expedited Access Program April 10, 2015 The new rules will allow more information on breakthrough technologies to fill unmet medical needs to be gathered postmarket. Read More
HeartWare’s Ventricular Assist System Wins Health Canada Nod April 10, 2015 The system’s HVAD Pump can be implanted without the usual invasive abdominal surgery required. Read More
IV Monitoring Device Wins FDA Nod April 9, 2015 The device is the first of its kind capable of continuously monitoring peripheral IVs. Read More
Aethlon Pursues Humanitarian Use Device Exemption for Ebola Treatment April 9, 2015 The device targets antivral drug resistance in viral pathogens. Read More
Perseon's MicroThermX Wins FDA Nod for Laparoscopic Ablation Procedures April 8, 2015 The device uses precision-guided microwave energy to ablate cancerous soft tissue. Read More
Robotic Glove Developed to Help Stroke Victims April 7, 2015 The glove provides victims with exercises and games designed to counteract rigid, fixed- hand and -wrist postures. Read More
FDA OKs Delayed Gastric Emptying Diagnostic Breath Test April 7, 2015 The test does not use radioactive materials. Read More
FDA Expands Indication for Ethicon’s Bleeding Control Sealant Patch April 6, 2015 In clinical trials, devicemaker claims Evarrest showed 94 percent efficacy against the standard of care’s 53 percent. Read More
Augmenix’s SpaceOAR Prostate Treatment Receives FDA Clearance April 6, 2015 SpaceOAR is the first FDA-cleared product capable of protecting the rectum from prostate cancer radiotherapy in male patients. Read More