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FDA News
Biolase Laser Receives FDA OK for First Nondental Surgery
IRVINE, Calif., May 9, 2013 — Dental laser maker Biolase Inc.’s WaterLase iPlus all-tissue laser has been cleared by the US Food and Drug Administration for soft-tissue use in orthopedic and podiatric surgery, the company announced Wednesday. It is the first nondental clearance for its flagship product. Biolase Chairman and CEO Federico Pignatelli said the approval expands the product into two markets, each with tremendous potential. "Just the top ten orthopedic surgical soft-tissue procedures, for example, offer....
Lantos 3-D Ear Scanner Cleared by FDA
CAMBRIDGE, Mass., April 2, 2013 — MIT spinout Lantos Technologies Inc. has received FDA clearance for a 3-D ear-scanning system that streamlines the topology measurement process for custom-fit ear devices. The system could drive innovation in the hearing aid, consumer audio,...
People In The News
Apr 1, 2013 — Laser Energetics Inc. of Mercerville, N.J., has hired consultant Jerome E. Dennis to help bring its Dazer Laser products into full compliance with the requirements of the Center for Devices and Radiological Health (CDRH) of the FDA. Dennis, a...
Ophthalmic Laser System Cleared by FDA
CLERMONT-FERRAND, France, March 22, 2013 — Quantel Medical has received FDA 510(k) clearance for its Vitra Multispot ophthalmic laser system for diabetic eye disease treatment.
Tests Underscore Potential Hazards of Laser Pointers
GAITHERSBURG, Md., and ORLANDO, Fla., March 21, 2013 — Of the 122 laser pointers tested recently by the National Institute of Standards and Technology, nearly 90 percent of the green pointers and about 44 percent of the red were out of compliance with federal safety regulations, the agency reported...
Dazer Laser Now FDA Safety Compliant
MERCERVILLE, N.J., Feb. 26, 2013 — Laser Energetics Inc.’s Dazer Laser Guardian is now compliant with FDA safety regulations.
Block Engineering to Develop QCL System with Pfizer
MARLBOROUGH, Mass., Jan. 21, 2013 — Block Engineering has partnered with Pfizer Inc. to develop a quantum cascade laser based infrared spectroscopy system for noncontact cleaning verification of vessels during pharmaceutical manufacturing.
Pinnacle Biologics Acquires PDT Laser Tech
BANNOCKBURN, Ill., Dec. 5, 2012 — Pinnacle Biologics Inc. has completed its portfolio of photodynamic therapy (PDT) treatment components with the acquisition of Diomed’s PDT 630 laser and fiber optic diffuser Optiguide. Financial terms were not disclosed.
Clinical Trial Next for Laser Technique
Jul 1, 2012 — Carl Zeiss Meditec AG of Dublin, Calif., and Jena, Germany, has received conditional approval from the FDA to initiate a clinical trial for its ReLEx smile procedure to correct myopia. The technique for refractive surgery combines femtosecond laser...
Texas A&M Hosting Bio-Optics Conference
COLLEGE STATION, Texas, May 18, 2012 — The inaugural BioMedOpTex Symposium will take place May 23-25 at the Annenberg Presidential Conference Center at the George Bush Presidential Library.
Portable Probe Aims to Speed Oral Cancer Diagnosis
AUSTIN, Texas, April 30, 2012 — A new portable, miniature microscope could reduce the time it takes to diagnose oral cancer.
FDA OKs Spectranetics’ GlideLight Laser Sheath
COLORADO SPRINGS, Colo., April 26, 2012 — The single-use medical device developer’s GlideLight Laser Sheath for the removal of cardiac leads has received FDA approval.
Carl Zeiss Meditec Laser Technique to Begin Clinical Trials
DUBLIN, Calif., and JENA, Germany, April 24, 2012 — The medical technology supplier has received conditional approval from the FDA to initiate a clinical trial for its ReLEx smile procedure to correct myopia.
Device Spots Deadly Melanoma, Cell by Cell
COLUMBIA, Mo., Jan. 11, 2012 — A tool based on laser-induced ultrasound technology can detect single melanoma cells in a blood sample at a fraction of the cost of current cancer tests. A prototype developed at the University of Missouri’s Bond Life Sciences Center is now poised...
Optim Acquires Company
Jan 1, 2012 — Endoscope manufacturer Optim LLC has acquired Precision Endoscopic Technologies, formerly Max Endoscopy of Mentor, Ohio. The new company, called Precision Endoscopic Technologies LLC, will operate as a division of Optim and will be collocated at its...
Multiphoton Endoscope May Equal Fewer Biopsies
ITHACA, N.Y., Nov. 3, 2011 — Taking multiphoton microscopy into a new dimension, a new imaging device under development that can be inserted safely into a patient’s body could minimize the need for unnecessary biopsies. Researchers at Cornell University are...
Optim Acquires Precision Endoscopic Technologies
STURBRIDGE, Mass., Nov. 2, 2011 — Endoscope manufacturer Optim LLC has acquired Precision Endoscopic Technologies, formerly MAX Endoscopy of Mentor, Ohio. The new company, called Precision Endoscopic Technologies LLC, will operate as a division of Optim and will be collocated...
BMW Headlights to Get Lasers
Nov 1, 2011 — BMW will incorporate lasers into its headlights for the first time, using its new concept vehicle, the i8, to demonstrate. The lasers, which are 1000 times more intense than conventional LEDs, are safe and could result in significant fuel savings....
Laser Approach Advantageous for Cataract Surgery
ORLANDO, Fla., Oct. 25, 2011 — Two new studies on the use of femtosecond laser procedures in cataract surgery back the argument that the technology may be safer and more efficient than the standard procedures used today. According to data presented at the annual meeting of...
BMW to Replace LED Headlights with Lasers
MUNICH, Sept. 14, 2011 — BMW made headlines last week when it announced that it would incorporate lasers into its headlights for the first time, starting with its new plug-in hybrid, the i8 Concept. The lasers, which are 1000 times more intense than conventional LEDs, are...
Optical Filters Take Food Inspection to a Whole New Level
Jul 1, 2011 — Multispectral machine vision systems are one way to speed up quality control on production lines – and to make sure our food is safe for consumption. Foodborne diseases affect approximately 48 million people in the US each year, according to...
FDA Approves Human Trials of Cornell Dots
Jun 20, 2011 — NEW YORK, June 20, 2011 — The first clinical trial in humans of a new technology called Cornell Dots — brightly glowing nanoparticles that can light up cancer cells in PET-optical imaging — has been approved by the FDA. The new...
FDA OKs Zeiss Laser for Hyperopia
DUBLIN, Calif., April 11, 2011 — Carl Zeiss Meditec Inc. announced that its MEL 80 excimer laser has received premarket approval from the FDA for the treatment of hyperopia. The new indication complements the existing FDA-approved applications of the surgical laser for myopia and...
Photodynamic Therapy Treats HPV Nonsurgically
CAMBRIDGE, Mass., March 28, 2011 — A nonsurgical photodynamic therapy (PDT) procedure is being developed to destroy tissue infected by human papilloma virus (HPV) and treat precancerous lesions on the cervix without damaging healthy tissue. Unlike previous applications of PDT...
FDA Greenlights Kodak Laser Projection Technology
ROCHESTER, N.Y., Feb. 28, 2011 — The FDA announced the approval of a variance that allows the sale of Kodak laser projector systems using the company’s laser projection technology to cinema exhibitors without the need for individual site or show operator variances. The...
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