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FDA News
‘C Dots’ Head to Clinical Trial
ITHACA, N.Y., Feb. 2, 2011 — “Cornell Dots” — brightly glowing nanoparticles — may soon be used to illuminate cancer cells to aid in diagnosis and treatment. The FDA has approved the new technology for the first clinical trial in humans. It is the first time that the FDA has approved using an inorganic material in humans in the same fashion as a drug. “The FDA approval finally puts a federal approval stamp on all the assumptions we have been working under for years. This is really, really...
Octopus Invests in Michelson Diagnostics
ORPINGTON, England, Nov. 11, 2010 — Octopus Investments Ltd. announced an investment of £1.7 million into Michelson Diagnostics Ltd., a medical equipment and scanner provider, whose laser scanning technology can image skin and other surface tissue at higher resolutions than ever...
Palomar to Launch Home-use Laser by Spring
BURLINGTON, Mass., Sept. 27, 2010 — Palomar Medical Technologies Inc., a developer of light-based systems for cosmetic treatments, announced that it would move the launch of its patented, home-use laser for the treatment of periorbital wrinkles by a few months.
Mini Telescope Implant Approved
SARATOGA, Calif., July 9, 2010 — The US Food and Drug Administration (FDA) has announced approval of an implantable miniature telescope (IMT) made by VisionCare Ophthalmic Technologies Inc. to improve vision in some patients with end-stage age-related macular degeneration (AMD)....
Alcon to Acquire LenSx Lasers
FORT WORTH, Texas, July 7, 2010 — Eyecare company Alcon Inc. will acquire privately held LenSx Lasers Inc., developer of a femtosecond laser used in cataract surgery, for $361.5 million, Alcon announced Tuesday. The LenSx system, the first femtosecond laser to receive US Food and...
LIA: Becoming the Laser Institute of America
Jul 1, 2010 — As just about everyone knows, American physicist Theodore Maiman fired the first laser in May 1960 in Malibu, Calif. What is less well-known is that, in February 1968, also in California, Maiman and other laser pioneers founded the Laser Industry...
Spectranetics Settles Class Action Suit for $8.5M
COLORADO SPRINGS, Colo., June 22, 2010 — Medical laser maker Spectranetics Corp. announced Tuesday that it has settled a pending class-action suit for $8.5 million in cash and has also settled a stockholder derivatives case for payment of attorneys fees. The class-action suit was filed in...
Lantis Laser, Perio-Imaging to Merge
DENVILLE, N.J., June 18, 2010 — Lantis Laser Inc. announced it will merge with Perio-Imaging Inc., a private New York-based company that makes an ultrasongographic periodontal probe system. The merger would be an all-stock transaction. The name of the new company will be announced...
Hybridyne Medical Imaging System OK’d by FDA
TORONTO, April 29, 2010 — Hybridyne Imaging Technologies Inc. announced it has received FDA clearance for its ProxiScan system. Using planar imaging techniques, the system can be used in imaging the distribution of radionuclides in the human body. It may also be used...
NIR spectroscopy to predict pill quality
BALTIMORE – The quality-testing process for pharmaceuticals raises drug costs, according to pharmacy professor Stephen Hoag, but he says that evaluation with near-infrared spectroscopy could help lower those costs. “The drug industry used to test a pill...
VivoSight Gains 510(k) Clearance
ORPINGTON, UK, Jan. 15, 2010 -- The London-based developer and manufacturer of Optical Coherence Tomography (OCT) products, Michelson Diagnostics Ltd. has been awarded 510(k) clearance from the US Food & Drug Administration (FDA) for its VivoSight OCT scanning product. The...
Spectranetics to Pay Feds $5M
COLORADO SPRINGS, Colo., Dec. 30, 2009 –- Excimer laser maker Spectranetics Corp. has agreed to pay the US $4.9 million in civil damages plus $100,000 in cash or property to resolve claims against the company, the Justice Department announced Tuesday. “I believe that our level of...
UV Light Detects Salmonella
AMES, Iowa, Feb. 3, 2009 – After the recent outbreak of Salmonella in the US, which has sickened more than 500 people and killed eight, the federal government has launched a criminal investigation that will be carried out by the FDA’s criminal division and the Department of...
Lasik Is Safe, But Mishaps Can Occur
Oct 22, 2008 — Lasik can change the lives of people dependent on glasses or contact lenses. People who have lasik no longer have to search blindly for those glasses if they break or get misplaced. They don't need to go through the ritual of putting on contact...
Spectroscopy Hunts Down Counterfeit Drugs
Oct 1, 2008 — Consumers are using the Internet to buy prescription drugs more cheaply, sometimes without a prescription, but they may get more than they bargained for because some unscrupulous retailers provide fake or adulterated drugs. The problem has been...
Feds Raid Spectranetics
COLORADO SPRINGS, Colo., Sep. 5, 2008 -- Spectranetics Corp. said it is cooperating fully with an investigation related to its products and business practices after a raid by federal authorities on Thursday. Spectranetics, which makes an excimer laser used in minimally invasive...
Sandstone to Stop Imports
BIRMINGHAM, Ala., June 16, 2008 -- A US Food and Drug Administration (FDA) warning has prompted, in part, a small Alabama laser company to expand its US manufacturing operations. Sandstone Medical Technologies LLC, a Birmingham-based producer of new and reconditioned lasers used...
Hologic Acquiring Third Wave
BEDFORD, Mass., June 11, 2008 -- Medical imaging systems maker Hologic Inc. announced it will acquire Third Wave Technologies Inc. for $11.25 per share, or approximately $580 million. Madison, Wis.-based Third Wave develops molecular diagnostic reagents for DNA and RNA analysis...
FDA OKs NIR Plaque Imager
BURLINGTON, Mass., May 8, 2008 -- A device that lets a doctor see inside a blood vessel to assess the fat content of plaque in arteries has been cleared for marketing by the US Food and Drug Administration. The InfraReDx LipiScan NIR catheter imaging system uses near-infrared...
Zygo Optical Systems Div.: A Tier 1 Electro-Optical Device Supplier
MIDDLEFIELD, Conn., April 9, 2008 -- Zygo Corp.'s reputation for state-of-the-art interferometry is well known throughout the world. For almost four decades, however, the company has also been manufacturing high-precision optical components and systems serving applications ranging from...
FDA OKs Laser Hair-Removal Device for Home Use
Feb 7, 2008 — SpectraGenics, a Pleasanton, Calif.-based maker of aesthetic lasers, today announced over-the-counter (OTC) clearance from the US Food and Drug Administration (FDA) for its patented handheld laser hair-removal device for home use. The Tria will be...
FDA Nanotech Role Outlined
WASHINGTON, July 31, 2007 -- The US Food and Drug Administration (FDA) should consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology, according to a report released by the FDA Nanotechnology Task...
House OKs Laser Pointer Bill
WASHINGTON, May 23, 2007 -- Anyone who is seized by the urge to point a laser pointer at the cockpit of an airplane might think better of it, thanks to a bill passed by the House of Representatives that would make it a criminal act punishable by five years in prison. Sponsored...
Study Urges Nano Oversight
WASHINGTON, May 23, 2007 -- Although the general public continues to know little to nothing about nanotechnology -- the manipulation of matter on an atomic scale -- the number of consumer products containing some aspect of it has now surpassed 450 and is increasingly rapidly,...
Analytical Spectral Devices Receives 2006 IQ Award
Aug 25, 2006 — Analytical Spectral Devices Inc. (ASD), a Boulder, Colo.-based maker of quality control instruments, has received the 2006 IQ (Innovation Quotient) Award in the Medical and Health Products category for its RxSpec drug verification technology. The...
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