Former Beaumont Employees and Medical Device Distributor Charged with Wire Fraud for a Scheme to Steal Medical Devices
FDA OCI, Paul Purdy, Beavercreek OH, Valdet Seferovic, Auburn Hills MI, Zafar Khan, Fenton MI, wire fraud, medical devices, steal, medical supplies, Beaumont Hospital, cystoscopes, contaminated, ophthalmoscopes, otoscopes, internet, sold, Wholesale Medical& Surgical Suppliers of America, indictmen (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - January 15, 2021 Category: Medical Law Authors: DOJ Source Type: news
Iridex wins FDA 510(k) for TruFocus LIO premiere ophthalmological laser
Iridex (NSDQ:IRIX) said yesterday it won FDA 510(k) clearance for its TruFocus LIO premiere ophthalmological laser accessory and that it launched the device in the US.
The TruFocus LIO Premiere is a light combination and reflection viewing system designed to be used with the Iridex retina laser system, the Mountain View, Calif.-based company said.
The newly cleared device is designed to be worn on the physician’s head and combines a laser treatment beam with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam which can be used with a handheld examination lens to view and treat a pa...
Source: Mass Device - September 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Iridex Corp. Source Type: news
Telemedicine Useful in Detecting Retinopathy of Prematurity Telemedicine Useful in Detecting Retinopathy of Prematurity
Telemedicine has similar accuracy to ophthalmoscopy in detecting clinically significant retinopathy of prematurity (ROP), researchers say.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 13, 2018 Category: Consumer Health News Tags: Ophthalmology News Source Type: news
Ophthalmoscopy, Telemedicine Similar in Accuracy to ID ROP
FRIDAY, April 6, 2018 -- Ophthalmoscopy and telemedicine are similarly accurate for detection of clinically significant retinopathy of prematurity (ROP), according to a study published online April 5 in JAMA Ophthalmology.
Hilal Biten, M.D., from... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 6, 2018 Category: Pharmaceuticals Source Type: news
Telemedicine Matches Ophthalmoscopy for ROP Dx (CME/CE)
(MedPage Today) -- Similar sensitivity for most types of clinically significant disease (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - April 6, 2018 Category: Pediatrics Source Type: news
Iridex dives after cutting outlook on eye laser component recall
Iridex (NSDQ:IRIX) shares took a big hit today after the company said last week that it’s recalling a component used with its eye laser surgery device after receiving three reports of permanent injuries associated with it.
Mountain View, Calif.-based Iridex said Feb. 23 that it’s pulling all 104 of its TriFocus Lio Premier ophthalmoscopes.
The three injury reports “stated that the procedures resulted in patients experiencing permanent damage to the eye, including focal cataracts and iris burns.”
“Customers who have the TruFocus LIO Premiere should stop using it. Iridex is notifying its distri...
Source: Mass Device - February 26, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Optical/Ophthalmic Recalls Wall Street Beat Iridex Corp. Source Type: news
FDA exempts 1,003 Class II devices from 510(k) requirements
The FDA this week finalized a list of 1,003 Class II medical devices that will no longer require 510(k) clearances.
The list was drafted and published in March as part of the 21st Century Cures Act, looking to decrease the regulatory burden on the FDA and decrease costs for medical device companies.
Included on the list are dentures, cartridge syringes, surgical light sources, esophageal dilators, surgical drapes, forceps and umbilical clamps, perineal heaters, ophthalmoscopes and a wealth of other devices.
The federal watchdog noted that while the devices are exempt from 510(k) clearance, they are still under their regula...
Source: Mass Device - July 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
New glaucoma test could save millions from blindness
Conclusion
Glaucoma is responsible for about 10 in 100 people registered blind in the UK. About 2 in 100 people over 40 in the UK have glaucoma, and around 10 in 100 of those aged over 75. Because there is no cure, but early treatment can often help slow or prevent damage, early diagnosis is important.
Regular eye tests may pick up glaucoma, but often there's no sign of the disease until people have already begun to lose vision. That's why this test is interesting. If it can be shown to work well and safely, it could be a quick and efficient way to diagnose glaucoma before people have started to lose their sight. However, ...
Source: NHS News Feed - April 27, 2017 Category: Consumer Health News Tags: Medical practice Older people Source Type: news
Dx: Ruptured Vessel
The ultrasound image shows a view of the globe with the retina at the bottom of the image. The vitreous humor appears anechoic (black) and the retina echoic (gray). Just in front of the retina is a small echoic area that was not present in the unaffected eye. It does not appear to be connected to the retina, making it a bit atypical in appearance for a retinal detachment. A vitreous detachment could also look like this on ultrasound, but would also be attached at some point to the posterior globe. Examination by ophthalmology with his fancy gadgets and unique skill set revealed that this echoic area seen on ultrasound was ...
Source: EPMonthly.com - December 2, 2016 Category: Emergency Medicine Authors: Logan Plaster Tags: Uncategorized Source Type: news
Detection of airbag impact-induced cone photoreceptor damage by adaptive optics scanning laser ophthalmoscopy: a case report - Kaizu Y, Nakao S, Yamaguchi M, Murakami Y, Salehi-Had H, Ishibashi T.
BACKGROUND: The purpose of this study was to report a case of traumatic maculopathy with para-central visual field defects following an impact by airbag deployment using adaptive optics scanning laser ophthalmoscopy (AO-SLO). CASE PRESENTATION: A 51-year-o... (Source: SafetyLit)
Source: SafetyLit - July 10, 2016 Category: Global & Universal Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
Study identifies risk factors associated with eye abnormalities in infants with presumed Zika virus
Researchers have assessed and identified possible risk factors for ophthalmoscopic (an instrument used to visualize the back of the eye) findings in infants born with microcephaly (a birth defect characterized by an abnormally small head) and a presumed clinical diagnosis of Zika virus intrauterine infection. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - May 26, 2016 Category: Science Source Type: news
Cheap device for examining eyes successfully tested
Pocket-sized ophthalmoscope could improve medical care and training in developing countries. (Source: SciDev.Net)
Source: SciDev.Net - April 27, 2016 Category: Global & Universal Source Type: news
Make the Diagnosis: Blurred vision, "flashes of light"
(MedPage Today) -- Case Findings: A 70 year old man presents with blurred vision and a nasal field defect in one of his eyes. Prior to arriving in the emergency department, he saw flashes of light and floaters, accompanied by a shower of black dots blocking his vision. When examining his eye with indirect ophthalmoscopy with scleral depression, you see the accompanying picture. (Source: MedPage Today Ophthalmology)
Source: MedPage Today Ophthalmology - October 5, 2015 Category: Opthalmology Source Type: news
Unusual intraocular foreign bodies after an explosion: patient's hand bone fragments - Sonmez M, Duzgun E, Yildirim Y, Ayata A, Unal MH.
A 26-year-old Turkish Army soldier underwent full ophthalmoscopic examination after a penetrating ocular injury in the left eye due to the accidental explosion of a detonating fuse during handling. Visual acuity of the left eye was hand motion level. Fundu... (Source: SafetyLit: All (Unduplicated))
Source: SafetyLit: All (Unduplicated) - August 8, 2015 Category: Global & Universal Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news
