Approval/Clearance

Bausch + Lomb, has extended the CE mark status for its VICTUS® femtosecond laser platform to include the creation of corneal incisions in patients undergoing cataract surgery. Two other new indications were included, including penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.

Monteris® Medical has announced that the U.S. FDA has issued a second 510(k) clearance for its MRI-guided ablation device for brain tumors and other lesions.

The FDA has approved an IDE for InVivo’s biopolymer scaffold, making it the first such treatment to dip its toe in the America patient population. The new study is expected to deliver a Humanitarian Device Exemption, giving it access to market sooner than a PMA.

This weekend (April 6-9) sees the 35th running of the Charing Cross Vascular Symposium in London. Medtronic has just received CE mark approval for its new AAA stent graft introducer sheath and will be showcasing it among its other offerings at the event.

Hitachi Medical Systems America, Inc., has announced FDA clearance to market its SCENARIA Advanced 128 CT system, the newest model of the SCENARIA scalable CT platform. The company claims enhanced patient access and rapid workflow for its 128-slice model that it says provides both routine and advanced applications with enhanced performance and value.

The SAM Junctional Tourniquet has been FDA 510(k) cleared for market. The device is designed to control bleeding where standard tourniquets would not be effective.

Endoscopic device company Apollo Endosurgery, Inc., has announced that its OverStitch™ Endoscopic Suturing System has gained European CE Mark approval. The company plans to immediately launch the system to select centers in several European countries.

Medtronic, Inc. has gained U.S. FDA 510(k) clearance of its new Affinity Fusion® oxygenation system. The system is designed to serve as a patient’s lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures.

Training simulator company Simbionix USA Corporation, has received FDA clearance for its TEVAR application for PROcedure Rehearsal Studio™ . This application joins the family of PRS cleared for marketing applications for Carotid Intervention and EVAR procedures.

Cardiac device and remote monitoring specialist company Biotronik is 50 years old. The company is having a double celebration as it is also announcing the CE mark approval of its MRI compatible Iforia ICD/CRT-D implant

Tenex Health’s TX1 is a clever ultrasonic device can cut and debride damaged tendon without affecting the surrounding healthy tissue. Now FDA has expanded its indications with a new 510(k) clearance that enables the company to press on with its pipeline of applications.

Heart failure is associated with increased myocardial sympathetic nerve activity, which in turn depletes local capacity for norepinephrine uptake and storage. AdreView measures that capacity, so provides an indication of heart disease status.

iCAD, Inc., has received U.S. FDA clearance for its new cervical applicator for use with its Xoft® Axxent® Electronic Brachytherapy System® to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

MEDICREA group has gained FDA approval of its PASS® LP system for the treatment of adolescent idiopathic scoliosis. The PASS® LP is the lowest profile pedicle screw spinal fusion system available on the market and has been designed to address the most complex spinal pathologies making it specifically adapted to pediatric indications.

Sorin’s newly approved RESPOND CRT trial aims to demonstrate clinical benefit of innovative SonR® CRT optimization system in cardiac resynchronization therapy.

In short What a peculiar and unusual series of events the final throes of MitraClip’s progress to FDA approval have … continue reading “FDA Panel Not Unanimous On MitraClip, But Approval Likely”