U.S. health officials are making a high-tech screening device available in Africa to help spot counterfeit malaria pills in hopes that the technology may eventually be used to combat the fake drug trade worldwide. The Food and Drug Administration announced Wednesday that U.S. partners in Ghana will begin using a U.S.-developed handheld device...
K2M, Inc., the largest privately held spinal device company in the world focused on developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced another expansion of the company’s U.S. biologics offering with the addition of a new product line to the VESUVIUS™ Osteobiologic Systems.
HelpMeSee has achieved a significant milestone in medical simulation by successfully testing virtual reality surgical training simulators as a proof of concept. This success led HelpMeSee to select Moog for a joint development contract to design and produce a high-fidelity virtual reality Eye Surgery Simulator and courseware model to train cataract surgeons...
Vycor Medical, Inc. announced today it has secured two new patents (2008-518369 and 11/993280) covering its Spinal ViewSite Cervical Access System (VCAS). The addition of these patents brings Vycor's total patent portfolio to 34 issued and 21 pending. The Company's...
Ethicon Launches Next Generation Energy Device at American Society of Colon and Rectal Surgeons’ Annual MeetingApril 25, 2013 8:30 am | by The Associated Press | Comments
To expand choice and help surgeons provide greater precision, Ethicon Endo-Surgery, Inc. today announces the launch of the HARMONIC ACE + Shears with Adaptive Tissue Technology (HARMONIC ACE + Shears), the next generation product in the best-in-class HARMONIC portfolio of ultrasonic surgical devices that can handle multiple surgical jobs
A*STAR and Veredus Laboratories Create Market's First Lab-on-Chip for the Detection of Multiple Tropical Infectious DiseasesApril 25, 2013 3:01 am | by The Associated Press | Comments
The Agency for Science, Technology and Research (A*STAR) and Veredus Laboratories, a leading supplier of innovative molecular diagnostic tools, announced the launch of VereTrop, the first biochip in the molecular diagnostics market that can identify 13 different major tropical diseases from...
Profound Medical Announces Initiation of TULSA Clinical Trial for Treatment of Localized Prostate CancerApril 25, 2013 12:01 am | by PR Newswire | Comments
Profound Medical Inc. today announced the commencement of its Health Canada approved, multi-center TULSA clinical trial for its minimally invasive, novel ablation device used to facilitate prostate cancer treatment. In the world's first procedure of its kind, a patient was treated in a collaborative effort with London Health Sciences Center...
Meeting Announcement: July 24-25, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory CommitteeApril 25, 2013 12:00 am | by U.S. Food & Drug Administration | Comments
On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device.
510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, May 17, 2013April 25, 2013 12:00 am | by U.S. Food & Drug Administration | Comments
The purpose of the meeting is to discuss FDA’s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal Register notice associated with this meeting and in discussion during the public meeting.
Humans are veritable chemical factories - we manufacture thousands of substances and transport them, via our blood, throughout our bodies. Some of these substances can be used as indicators of our health status. A team of EPFL scientists has developed a tiny device that can analyze the concentration of these substances in the blood.
Ergoresearch Ltd. and Victhom Human Bionics Inc. announced today that the Superior Court of Québec has issued a final order approving the previously-announced plan of arrangement relating to the acquisition by Ergoresearch Inc., a direct wholly-owned subsidiary of Ergoresearch, of Victhom.
Eastman Chemical Company has announced it will expand its non-phthalate plasticizer portfolio with the addition of Eastman 168™ SG (sensitive grade) non-phthalate plasticizer. Eastman 168 SG non-phthalate plasticizer is an enhanced grade of the Eastman 168 non-phthalate plasticizer.
Medstrat, Inc., a leading provider of picture archiving and communications system (PACS) technology to Orthopaedic practices and hospital systems, announced today that it has posted the terms of the Settlement Agreement by which Merge Healthcare dismissed its November 14, 2012 lawsuit filed against Medstrat.
Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting StentApril 24, 2013 4:40 pm | by The Associated Press | Comments
Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent.
Life Care Medical Devices Ltd Announces CE Mark And Planned Commercialization For Laparoscopic Surgery Access DeviceApril 24, 2013 4:29 pm | by The Associated Press | Comments
Life Care Medical Devices Ltd today announced the issuance in August 2012 of CE mark for its Keyhole Cup Laparoscopic Access Device. Keyhole Cup addresses a critical need in the laparoscopic surgery market and was developed to advance the standard of care for laparoscopic access.