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FDA News
Rockley Completes Human Studies of Blood Pressure Monitor
OXFORD, England, Aug. 24, 2023 — Rockley Photonics has completed two IRB-approved human studies using a first-generation Alpha prototype of their noninvasive laser-based cuffless blood pressure monitor. The device is currently in advanced development. The first study successfully demonstrated intra-subject tracking of blood pressure compared to measurements using an intra-arterial pressure transducer, or an A-line, which is the gold-standard method to continuously monitor blood pressure during surgery and in the ICU. The
SpectraWAVE Secures FDA Clearance for Intravascular Imaging Tech
BEDFORD, Mass., March 14, 2023 — Medical imaging company SpectraWAVE has received 510(k) clearance from the Food and Drug Administration (FDA) for its intravascular imaging system, HyperVue. The dual modality system combines OCT and near-infrared spectroscopy (NIRS) to support...
NIR Spectroscopy Could Provide Window into AD Pathology, Therapeutics
BEDFORD, Mass., Sept. 1, 2021 — To detect Alzheimer’s disease (AD) in its early stages, researchers at the VA Bedford and VA Boston Healthcare systems developed a noninvasive optical technique that uses near-infrared spectroscopy to identify changes in the brain by capturing...
FDA Approves Zeiss’ ReLEx SMILE
DUBLIN, Calif., Nov. 19, 2018 — Zeiss’ medical technology segment has announced FDA pre-market approval (PMA) for its ReLEx SMILE system, expanding myopia treatment to patients with astigmatism. ReLEx SMILE utilizes the high-precision femtosecond laser VisuMax to create a...
FDA Approves Laser Phototherapy Device for Hair Restoration in Men
PLEASANTON, Calif., April 11, 2018 — Medical device maker Theradome has received U.S. FDA clearance to market its LH80 PRO laser phototherapy hair restoration device to men. Theradome's LH80 PRO Laser Helmet, which uses laser phototherapy to stimulate hair growth, is now U.S....
Ra Medical Systems Receives FDA Clearance for Laser Ablation
CARLSBAD, Calif., June 12, 2017 — In an effort to battle Peripheral Artery Disease (PAD), the leading cause of limb amputations, the U.S. Food and Drug Administration (FDA) has granted market clearance to laser developer Ra Medical Systems Inc., makers of excimer lasers and...
Biolase Epic Pro Dental Laser Receives FDA Approval
IRVINE, Calif., Jan. 26, 2017 — Dental laser manufacturer Biolase Inc. has received U.S. Food and Drug Administration approval of its Epic Pro laser systems, offering higher laser power than most diode lasers in dentistry. The Epic Pro is the first commercially available laser...
FDA Clears Zeiss Ocular Imaging System
JENA, Germany, Nov. 29, 2016 — Carl Zeiss Meditec AG has received U.S. Food and Drug Administration (FDA) clearance for its PLEX Elite 9000 Swept-Source OCT posterior ocular imaging system, expanding the potential for clinical researchers to open new frontiers of discovery in...
FDA Clears USA Laser Biotech Lasers
RICHMOND, Va., Aug. 5, 2016 — USA Laser Biotech Inc. has received FDA 510(k) clearance for the Lumix laser series, combining and synchronizing high-power super-pulsed and continuous wave capabilities. The Lumix 3 and Lumix 4 lasers provide pulse rates of up to 100,000 Hz. Higher...
ANA-Detecting Microscope Cleared by FDA
SACRAMENTO, Calif., July 25, 2016 — The Image Navigator automated microscope from diagnostic instrumentation developer Immuno Concepts Inc. has been cleared by the U.S. Food and Drug Administration as being safe and effective. The Image Navigator eliminates the labor of indirect...
Lunula Laser Receives FDA Approval to Treat Nail Fungus
MCKINNEY, Texas, July 21, 2016 — The low-level Lunula Laser from Erchonia Corp. has received 510(k) approval from the U.S. FDA. Erchonia said it is the first low-level laser to receive marketing clearance for the treatment of onychomycosis, or nail fungus.
Concordia’s Photodynamic Therapy Laser Receives Premarket Approval
OAKVILLE, Ontario, July 19, 2016 — Concordia International Corp. said that the U.S. Food and Drug Administration has approved the Company's premarket approval application for its Photofrin 630 PDT (photodynamic therapy) Laser.
FDA Approves Implantable Vision-Correcting Lens
SILVER SPRING, Md., July 8, 2016 — The U.S. Food and Drug Administration (FDA) has approved Revision Optics Inc.’s Raindrop Near Vision Inlay device that corrects near vision for patients with presbyopia, providing an alternative for surgical, outpatient treatment of the disease.
Mauna Kea Miniprobe Receives FDA Clearance
PARIS, June 2, 2016 — Microscopy developer Mauna Kea Technologies SA has received its twelfth 510(k) clearance from the U.S. Food and Drug Administration (FDA). The new FDA clearance covers its confocal miniprobes for use in urological and minimally-invasive surgical...
Member Exclusive
Delivering Optical Devices to the Medical Market
Mar 1, 2016 — Medical optics is big business. The global market for medical device technologies is expected to reach $538.7 billion in 2018, registering a compound annual growth rate (CAGR) of 5.5 percent over five years, according to market analysts at BCC...
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High-Tech Glasses Show Cancer Cells
ST. LOUIS, March 14, 2014 — Distinguishing between cancer cells and healthy cells could become easier for surgeons. And all they'll need to do is put on glasses.
US Research Spending Decline Driven By Industry
ANN ARBOR, Mich., Jan. 2, 2014 — A sharp drop in US spending on biomedical research has been driven almost entirely by reduced investments from industry, not the public sector, a new study finds. The US’s global share of biomedical research spending fell from 51 percent in...
Partnership to Advance Optical Biopsies
PARIS and LONDON, Dec. 18, 2013 — Medical device company Mauna Kea Technologies and Imperial College London are partnering to advance research and applications of Mauna Kea’s optical biopsy platform, the partners announced recently. Mauna Kea’s Cellvizio is a probe-based...
Laser Helmet for Thinning Hair Launches in U.S.
PLEASANTON, Calif., Dec. 17, 2013 — The first clinical-level laser hair restoration product — the Theradome Laser Helmet LH80 PRO — is now available for in-home treatment of thinning hair and male pattern baldness, maker Theradome said this week. The product has been...
Laser cutting market could hit $3.77B in 2018
Sep 1, 2013 — The laser cutting market is expected to reach $3.77 billion in 2018, according to MarketsandMarkets of Dallas. The value of that market was $2.08 billion in 2012 but will reach nearly $4 billion in 2018, at an estimated compound annual growth rate...
Baby breathes easy with laser-printed air tube
ANN ARBOR, Mich. – When a child stops breathing, it’s a mother’s worst nightmare. And a doctor’s first instinct is not to reach for a laser to solve the problem. But in a recent extreme case, a laser-based process did indeed save the day. April...
Early Compliance Saves Money
Jul 1, 2013 — Don’t put off thinking about regulatory approval for a medical device that you are bringing to market – experts say you’ll save big in the long run. Medical devices must pass strict regulations before they are released for clinical...
Laser Cutting Market to Hit $3.77B in 2018
DALLAS, June 21, 2013 — The laser cutting market is expected to reach $3.77 billion in 2018, according to a new market research report. The report examines the laser cutting, drilling, marking and engraving market by technology (CO2 laser, excimer laser, Nd:YAG laser and...
Unique Phototherapy Device Begins US Sales
TAMPA, Fla., May 27, 2013 — Psoria-Light, a new device that treats skin disorders using targeted deep-UV LEDs, has started domestic sales, product maker Psoria-Shield announced.
Laser-Printed Air Tube Saves Baby’s Life
ANN ARBOR, Mich., May 24, 2013 — A baby boy can now breathe easy thanks to a 3-D-printed tracheal splint implant developed at the University of Michigan.
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