Pallor

FSIS ISSUES PUBLIC HEALTH ALERT FOR GROUND BEEF PRODUCTS DUE TO POSSIBLE E. COLI O157:H7 CONTAMINATION

Retrieved on: 
Samedi, avril 20, 2024

WASHINGTON, April 20, 2024 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ground beef products that may be contaminated with E. coli O157:H7.

Key Points: 
  • WASHINGTON, April 20, 2024 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for ground beef products that may be contaminated with E. coli O157:H7.
  • FSIS is issuing this public health alert to ensure that consumers are aware that these products should not be consumed.
  • The products have a “Use/Freeze by” date of April 22, 2024, and packaging date of “032824.” The list of products that are subject to the public health alert can be found here .
  • The company notified FSIS that they inadvertently used a portion of the contaminated beef to produce ground beef products that they subsequently shipped into commerce.

Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Lundi, novembre 13, 2023

NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage, topical ophthalmic company leveraging its Optejet® dispensing technology for both internally developed and acquired programs as well as out-licensing for additional indications, today announced its financial and operating results for the third quarter ended September 30, 2023.

Key Points: 
  • Advanced its Gen-2 Optejet device and anticipates shipping to MicroPine partners Bausch and Lomb and Arctic Vision by year-end 2023.
  • Research and development expenses totaled approximately $3.6 million for the third quarter of 2023 as compared to $3.9 million for the third quarter of 2022.
  • For the third quarter of 2023, general and administrative expenses were approximately $2.9 million, compared to $3.4 million for the third quarter of 2022.
  • Total operating expenses for the third quarter of 2023 were approximately $6.5 million compared to $7.2 million for the third quarter of 2022.

Critical Nursing Shortage Drives 117% Customer Spike for UbiSim Immersive Virtual Reality Simulation Training Platform

Retrieved on: 
Mardi, septembre 12, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230912362852/en/
    Screenshot from a UbiSim immersive virtual reality (VR) simulation for HIV & Shingles: Learners implement nursing interventions for a patient newly diagnosed with shingles and HIV.
  • The UbiSim platform is a complete simulation lab that provides nursing trainees with virtual access to a variety of clinical situations.
  • UbiSim lets faculty choose from 50-plus existing training scenarios created in collaboration with nursing educators and simulation experts.
  • The footprint for its VR training platform for nursing has expanded to nine countries, including the U.S. and Canada.

Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Jeudi, août 10, 2023

NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the second quarter ended June 30, 2023.

Key Points: 
  • Advanced its pre-NDA presbyopia program, Apersure (Microline), and anticipates commencing the manufacture of registration batches in the fourth quarter of 2023.
  • Research and development expenses totaled approximately $2.8 million for the second quarter of 2023 as compared to $3.6 million for the second quarter of 2022.
  • For the second quarter of 2023, general and administrative expenses were approximately $3.1 million, compared to $3.5 million for the second quarter of 2022.
  • Total operating expenses for the second quarter of 2023 were approximately $6.0 million compared to $7.1 million for the second quarter of 2022.

Eyenovia Announces First Commercial Sale of Mydcombi™

Retrieved on: 
Jeudi, août 3, 2023

NEW YORK, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis and developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced the first commercial sale of Mydcombi. Mydcombi was approved by the US Food and Drug Administration on May 8, 2023. The initial sale was to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who has become the first physician in the U.S. to incorporate Mydcombi into his daily practice.

Key Points: 
  • Mydcombi was approved by the US Food and Drug Administration on May 8, 2023.
  • The initial sale was to world-renowned board-certified ophthalmologist Dr. Nathan M. Radcliffe, who has become the first physician in the U.S. to incorporate Mydcombi into his daily practice.
  • The product should not be used in patients with known hypersensitivity to any component of the formulation.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

Eyenovia Announces Addition to Russell 2000® and Russell 3000® Indexes

Retrieved on: 
Lundi, juin 26, 2023

Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of April 28, ranking them by total market capitalization.

Key Points: 
  • Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of April 28, ranking them by total market capitalization.
  • FTSE Russell determines membership for its Russell indexes primarily by objective, market capitalization rankings and style attributes.
  • “Our addition into the widely followed Russell Indexes is another important milestone reflecting the significant progress we have made in advancing our ophthalmic delivery platform,” stated Michael Rowe, chief executive officer of Eyenovia.
  • For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website .

Eyenovia Announces Presentation at the OCTANE Ophthalmology Tech Forum 2023

Retrieved on: 
Jeudi, juin 1, 2023

NEW YORK, June 01, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the company will be delivering a presentation at the annual OCTANE Ophthalmology Tech Forum 2023, which is being held June 8-9 in Newport Beach, CA.

Key Points: 
  • The presentation is scheduled for Friday, June 9th at 5:00 p.m. PDT.
  • “The theme of this year’s OCTANE forum, ‘Future Focused,’ will highlight recent innovations that will shape the future of ophthalmology, and we believe our novel Optejet technology will do just that,” stated Michael Rowe, chief executive officer of Eyenovia.
  • Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Also Leverages the Company’s Proprietary Optejet® Device Platform

Retrieved on: 
Lundi, mai 8, 2023

NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.

Key Points: 
  • The product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.
  • We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye.
  • Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)

How electric and automated cars are aggravating motion sickness

Retrieved on: 
Mercredi, mai 3, 2023

Around 25-30% of the population regularly suffers from motion sickness - a figure which some reckon to be conservative.

Key Points: 
  • Around 25-30% of the population regularly suffers from motion sickness - a figure which some reckon to be conservative.
  • Motion sickness is experienced most commonly in cars, giving rise to the term car sickness.
  • Passengers are prone to feeling sick because they are deprived of the capacity to anticipate trajectories, in contrast to drivers.

Vehicle electrification: fewer landmarks and more sudden movements

    • This advantage has the downside of preventing certain car users from assimilating the movement of the vehicle.
    • For example, whereas we would associate acceleration with the engine revving in classic cars, electric cars suddenly deprive us of this reference point.

Digital interiors that encourage distraction

    • Another technological advance inducing motion sickness is the growing presence of ever larger and numerous screens inside vehicles.
    • These screens overburden users with visual information, which discourages them from looking outside.
    • the external view of the vehicle – which allow them to correctly perceive their position in space.

Autonomous driving and lack of anticipation

    • As mentioned above, this is problematic when we know the act of driving is the best way to anticipate trajectories and curb symptoms.
    • Moreover, the disappearance of the driving cockpit will make it possible to redesign vehicle interiors to become more welcoming, like a rolling living room.
    • This human dimension is set to disappear in autonomous vehicles, whose driving style will be less flexible and less natural than that of a human driver.

Human beings as the main obstacle to technological advances?

    • Considering the ethical, psychological and legal dimensions related to their development, it may be that human beings would become the main obstacle to the adoption of these new types of vehicles.
    • For these reasons, automotive manufacturers and suppliers have shown growing interest in this phenomenon in recent years.

FSIS Recall 011 - E. Coli O103

Retrieved on: 
Mardi, avril 26, 2022

The complete list of products and product codes for the beef products that are subject to recall can be found here .

Key Points: 
  • The complete list of products and product codes for the beef products that are subject to recall can be found here .
  • The problem was discovered during routine FSIS testing of imported products.
  • Many clinical laboratories do not test for non-O157 Shiga toxin-producing E. coli (STEC) such as O103 because it is harder to identify than STEC O157:H7.
  • FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.