Regulatory

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.

Abiomed gets the ball rolling with news that it has seen a first patient implated with its Impella RP in the U.S. IDE study into the device. Abiomed is seeking FDA approval under Humanitarian Device Exemption rules.

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.

The Freedom of Information act has come into its own with this one. A 2012 request has uncovered the fact that in direct contraditcion of its own press releases, Excite has not had Axiom FDA (510k) product approvals transferred to it, leaving such devices considered “adulterated and illegal”.

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.

In short We don’t know whether the FDA has its pen hovering over the tick box for MitraClip or not, … continue reading “Abbott’s MitraClip Suffers Untimely Setback”

At extremely high blood glucose levels (1024 mg/dL and above), the OneTouch® Verio®IQ Meter will not provide a warning and will shut off… so the company is recalling it.

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.

FDA proposals could see Automated External Defibrillators raised to class III status in an attempt to help manufacturers reduce the rather high incidence of adverse events that have been catalogued over recent years.

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”