Hansen Medical(R) Announces FDA Clearance of the Magellan(TM) Robotic Catheter eKit

MOUNTAIN VIEW, CA--(Feb 2, 2016) - Hansen Medical®, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Magellan™ Robotic Catheter eKit (MRC eKit). The MRC eKit is the company's latest addition to the family of approved Magellan Robotic Catheters and helps extend robotic capabilities and control throughout procedures in the peripheral vasculature. With the MRC eKit, physicians will now have robotic control of 3rd party microcatheters through the existing Magellan Robotic Catheter 6Fr architecture. This added ability has the potential to help reduce procedure times and radiation exposure.

This approval comes after multiple cases were performed with the MRC eKit by Professor Marc Sapoval, MD, MSc at Hôpital Européen Georges Pompidou (HEGP-APHP) in Paris, France as a part of the Embolization Procedures in Peripheral Vasculature clinical study. Professor Sapoval successfully performed several prostate artery embolization (PAE) procedures and uterine artery embolization (UFE) procedures with the MRC eKit as a part of this study.

Read more: Hansen Medical Inc ( HNSN )

Zecotek Granted U.S. Notice of Allowance for Enhanced LFS Crystal Array Manufacturing

SINGAPORE, Jan. 15, 2016 -Zecotek Photonics Inc. (TSX-V: ZMS; Frankfurt: W1I; OTCPK: ZMSPF),), a developer of leading-edge photonics technologies for industrial, healthcare and scientific markets, is pleased to announce that the U.S. Patent office has issued a Notice of Allowance for an enhanced LFS crystal array manufacturing process which allows for more flexible production output at a significantly improved price point.  The enhanced process produces LFS crystal arrays of various sizes and configurations at a competitive price when compared to other crystal arrays and single elements. 

Read more: Zecotek Photonics Inc ( ZMS )

TSO3 Completes Additional Studies, Files Extended U.S. Claims for Breakthrough Medical Device Sterilizer

Company Submits Required Documentation Seeking Clearance to Extend Sterilization Claims to Include up to Eight Channels in a Single Device for its STERIZONE® VP4 Sterilizer – an Industry First

QUÉBEC CITY, Dec. 22, 2015 TSO3 Inc. (TOS.TO), an innovator in sterilization technology for medical devices in healthcare settings, has filed with the U.S. Food and Drug Administration recently completed studies that support an expanded indication for use of its STERIZONE ® VP4 Sterilizer.

Regulatory clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for flexible endoscopes.

Read more: TSO3 Inc ( TOS )

ReWalk Robotics Secures Line of Credit of Up to $20 Million to Support Market Building Activities

YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Jan. 04, 2016 -- ReWalk Robotics Ltd. (RWLK) (“ReWalk” or “the Company”) today announced that it has entered into an agreement with Kreos Capital V (Expert Fund) Limited (“Kreos”) for a line of credit of up to $20 million.  ReWalk drew down an initial tranche of $12 million. An additional $8 million dollars will be available in separate tranches subject to certain conditions, with a minimum drawdown of $2 million per tranche.

Under the terms of the agreement, interest-only payments will be due for the first 12 months at a rate of 10.75% per annum. Thereafter, monthly principal and interest payments will be due through the December 2018 maturity date, which can be extended by an additional 12 months subject to certain conditions.

Read more: ReWalk Robotics Ltd ( RWLK )

pSivida's Medidur™ Meets Primary Efficacy Endpoint in Phase 3 Trial: High Statistical Significance in Prevention of Recurrence of Posterior Uveitis (p Less Than 0.00000001)

Statistical Significance in Improvement in Visual Acuity and Reduction in Systemic Therapy
Positive Safety Data

WATERTOWN, Mass., Dec. 22, 2015  -- pSivida Corp. (PSDV) (PVA.AX), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced positive topline results from its first Phase 3 clinical trial evaluating the safety and efficacy of Medidur™ for the treatment of chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis).

Read more: pSivida Corp ( PSDV )

Videos / Webinars

View all videos

Pepperstone | Metatrader 4 Forex Broker