Covidien has today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.
Thoracic/Respiratory
FDA Clearance For da Vinci Vessel Sealer: CE Mark Next?
Intuitive Surgical, Inc. has announced that it received FDA clearance to market its EndoWrist® One™ Vessel Sealer instrument for use with the da Vinci® Si™ Surgical System.
Second Patient Receives Seeded Synthetic Windpipe
Surgeons at the Karolinska Institute in Sweden have implanted a second patient with a synthetic trachea formed from CT scans of the patient’s own anatomy and seeded with his own stem cells.
Covidien Announces CE Mark for Nellcor™ Respiration Rate Software
Covidien extends the functionality of its Nellcor respiratory monitoring platform with CE Mark approval for its Nellcor™ Respiration Rate Version 1.0 Software and the Adult Respiration Rate Sensor.
AtriCure Aiming At Thoracoscopic Indication For AtriClip LAA Occlusion Device
MedCity News has reported on AtriCure’s quest to gain approval for use of the device in a minimally invasive fashion in stand-alone procedures to close the LAA.
FDA Provides Info On NeurX Diaphragm Pacing system
Following FDA’s approval under Humanitarian Device Exemption rules of Synapse Biomedical’s NeurX Diaphragm Pacing System in September it has now released further information.
NICE and British Lung Foundation Say Early Diagnosis Of COPD Can Slow Its Progress
UK’s National Institute for Clinical Excellence(NICE) states in a new article that charities are urging people who may be at risk of developing COPD should visit their doctor and have a spirometry test in order to get an early diagnosis of the condition.
Ethicon Endo-Surgery Receives 510(k) Clearance for New ENSEAL® G2 Curved and Straight Tissue Sealers Line — Broadest Range of Advanced Bipolar Tissue Sealers Available for Open and Minimally Invasive Surgery
Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its innovative ENSEAL® G2 Curved and Straight Tissue Sealers
Medical Device Alert on Venturi Air Entrainment Jet Adapters manufactured by Lifecare Hospital Supplies Ltd
UK MHRA has issued a Medical Devices Alert on Venturi Air Entrainment Jet Adapters supplied in kits with Oxygen facemasks and Tubing, manufactured by Lifecare Hospital Supplies Ltd.
“New” Indian Regulatory Rules Mean Surgical Staplers Are Now Drugs
Indian regulations step back in time as more devices fall under pharmaceutical controls
Tissuemed announces new CEO
New appointments at Tissuemed
Tissuemed’s core technology granted US patent
UK-based adhesive surgical sealant film manufacturer Tissuemed has been granted a US patent for a key component of its underlying technology.
Aesculap Unveils Cinch Organ Retractor for Laparoscopic Surgery
Aesculap has released the Cinch Organ Retractor for laparoscopic surgery, a device designed to retract organs during reduced and single-port surgery.
ETHICON ENDO-SURGERY INTRODUCES FIRST POWERED ENDOCUTTER WITH ENHANCED SYSTEM-WIDE COMPRESSION AND STABILITY, ALLOWING SURGEONS GREATER CONTROL IN LAPAROSCOPIC SURGERY
Innovative ECHELON FLEX™ Powered ENDOPATH® Stapler Reduces Inadvertent Movement of Distal Tip to Help Protect Tissue from Damage, Ensure Better Control and Smooth, Consistent Firing During Minimally Invasive Procedures
FDA approves ‘atmosphere-friendly’ COPD inhaler
The FDA has approved Boehringer Ingelheim’s Combivent Respimat, a propellant-free inhaler for patients with chronic obstructive pulmonary disease (COPD).
Clinical Data Demonstrates Long Term Safety of Boston Scientific’s Alair[TM]Bronchial Thermoplasty System
Five-year data from Research in Severe Asthma (RISA) Trial demonstrate maintenance of stable lung function and absence of late clinical complications. Patients in Europe with severe asthma can now benefit from unique and proven non-drug therapy.