Tag Archives: FDA

Having Committed to Growth in the New Year, Unicoeye Accelerates Its Online Expansion

WHIPPANY, N.J., Jan. 13, 2023 /PRNewswire/ — Unicoeye, an online retailer of colored contact lenses, is entering the new year with the ambitious goal of accelerating its online expansion. The company is committed to achieving growth in 2023 and is taking the necessary steps to ensure this goal is met. This includes focusing on new strategies to help increase its online presence, such as price adjustments and product promotions. Additionally, Unicoeye has shared some advice for consumers considering colored contact lenses.

Having Committed to Growth in the New Year, Unicoeye Accelerates Its Online Expansion
Having Committed to Growth in the New Year, Unicoeye Accelerates Its Online Expansion

Always insisting on putting customers first, Unicoeye stood out from many competitors in just a few years, and quickly became one of the most popular colored contact lens brands with vibrant original patterns and unique color combinations. As a professional colored contact lens brand, Unicoeye provides FDA-approved colored contacts shipped straight from their US warehouse, making sure customers receive their purchases within 2–6 days. For those looking for high-quality colored contact lenses at a reasonable price, lenses from Unicoeye are an excellent choice. Not only are they affordable, but they are also completely safe to wear. 

Likes and support from consumers motivate this brand to keep going and focus on delivering the best possible products and services. To achieve its planned online expansion, Unicoeye has decided to start by adjusting product prices and hosting promotions. Since January, the brand has lowered the prices of hot products on its website by up to 40%, with prices ranging from $9.99 to $16.99. It is worth mentioning that the brand is not reducing product quality to achieve this price reduction; on the contrary, they have been working hard to provide even better quality lenses. Further, multiple simultaneous promotions will allow customers to enjoy increased discounts on top of reduced prices. Anyone looking to temporarily change their eye color or enhance their makeup looks can visit the Unicoeye website for the most competitive prices.

“We hope those sales can help us build a good relationship with customers and also help spread awareness of our brand,” said the Unicoeye team. “With the right approach, we are confident that we can reach our goals of online expansion and overall growth this year.”

With the rise in popularity of colored contact lenses, it’s becoming commonplace to see them all over social media, worn by cosplayers, makeup artists, and countless other influencers. However, Unicoeye has noted that a certain fact about colored contacts needs to be more widely discussed, understood, and taken seriously. The Food and Drug Administration (FDA), a regulatory agency that creates guidelines for the protection of public health, requires colored contact lens vendors to be registered on their website due to the fact that colored contact lenses are considered medical devices. This means that those vendors must receive prior FDA authorization for their products to enter the U.S. and be commercially distributed. According to FDA regulations, compliance with registration can facilitate the supervision of a vendor’s products and allow consumers to report product-related problems and complaints. Therefore, it is important for colored contact lens brands to have FDA approval.

Unfortunately, some retailers sell colored contact lenses that do not meet the strict quality requirements established by the FDA. It is illegal to sell these lenses in the United States as they aren’t FDA-approved and may lead to eye infections and even cause blindness in severe cases after wearing them. Unicoeye, in addition to providing safe and FDA-approved lenses, also prioritizes its customers’ vision health by raising awareness of colored contact lens safety. For example, they recently shared an easy way for consumers to quickly verify whether the colored contact lenses they’ve purchased are FDA-approved: check whether the lenses are being shipped from the US. If they are shipped from a non-US warehouse or take weeks to arrive, this can be a sign that they are not FDA-approved.

Colored contacts are a great way to change up or enhance one’s look, but be sure to use colored contacts that the FDA approves to avoid eye injury. Unicoeye urges people interested in colored contacts to do thorough research before purchasing any lenses not directly provided by a pharmacy.

January Promotion Details:

-Buy 2 Get 1 Free
-Buy 3 Get 3 Free
-Buy 5 Get 6 Free

About Unicoeye

Unicoeye is a professional colored contact lens brand with a keen sense of fashion. Since its inception in 2019, the company has always been dedicated to providing safe and well-made products to every customer. Unicoeye insists on making eye health a top priority, using “sandwich printing” technology in their lenses to protect customers’ vision, and providing consumers with an FDA-approved purchasing experience.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/having-committed-to-growth-in-the-new-year-unicoeye-accelerates-its-online-expansion-301721389.html

Vieworks Wins FDA Approval for Its Newest VIVIX-S F series

ANYANG, South Korea, Aug. 5, 2022 /PRNewswire/ — Vieworks, a leading digital X-ray imaging solution provider based in South Korea, noted that its newest VIVIX-S F series has been authorized by the US Food and Drug Administration (FDA) last July. Regulatory clearance from the FDA will allow Vieworks to commercialize its new VIVIX-S F series, which is Vieworks’ premium static X-ray DR flat panel detectors equipped with advanced technology and cutting-edge hardware design. The cassette-sized DR detectors are offered in 3 sizes – 25x30cm (VIVIX-S 2530FW), 36x43cm (VIVIX-S 3643FW), and 43x43cm (VIVIX-S 4343FW).

VIVIX-S F series
VIVIX-S F series

1. FINEST Image Quality

  • High resolution images with 99µm pixel pitch
  • Semi-dynamic feature (multi-frame mode)
  • Anatomy-based image enhancement with photon-understanding AI solution
  • Advanced image processing technology (VXvue, Software-based Scatter Correction)

2. FINEST Durability

  • Unbreakable glass-free TFT (flexible TFT)
  • Excellent durability (1.5m drop tested, 400kg load limit)
  • IP67 water and dust resistance
  • Wider operating temperature

3. FINEST Usability

  • Lighter weight for greater portability
  • Convenient charging (wireless charging, separate battery charger, USB-C type, magnetic tether, cradle)
  • Long lasting battery life (16 hours with two batteries, hot-swap mode)
  • Easy usage with user-friendly functions (Fast and convenient detector sharing by NFC, OLED status screen)

Source: Vieworks Co., Ltd.

FDA Grants Donisi De Novo Clearance for Innovative Contact-Free Multiparameter Health Sensing Solution

TEL AVIV, Israel, May 5, 2021 — The U.S. Food and Drug Administration (FDA) has granted Donisi‘s revolutionary contact-free multiparameter measurement system de novo clearance, making Donisi the first to bring this innovative technology to the medical market.

Contact-Free Health Measurement and Decision Support. Donisi: Changing Lives Without Changing Lifestyles
Contact-Free Health Measurement and Decision Support. Donisi: Changing Lives Without Changing Lifestyles

In addition to the de novo clearance, the ingenuity of Donisi’s groundbreaking system was recently recognized via the publication of their clinical validation study in the Journal of Medical Engineering & Technology and winning first place in the MEDinISRAEL OpenMED Innovation Competition.

"I’m really proud of our team; we developed a medical device that can change the lives of millions of people. Our novel technology is now recognized and cleared by FDA which is a great accomplishment," said Donisi CEO, Yair Brosh.

Backed by 26 granted patents, the system applies a combination of proprietary optics, algorithms, and artificial intelligence to remotely detect and analyze surface-level micro-vibrations caused by the workings of internal organs such as heart and lungs.

Clinical results demonstrate Donisi’s technology maintains medical grade accuracy for people with different medical and physical conditions (physique, skin tone, etc.), without needing to remove clothing or connect the patient to wires or patches.

The company continues to develop its system, building ground-breaking solutions to measure and detect additional cardiopulmonary parameters, such as pulmonary congestion, in collaboration with the Cardiovascular Research Center at the Tel Aviv Sourasky Medical Center. Donisi has already undergone the FDA Presubmission process for the identification of atrial fibrillation (AFib) and plans for additional submissions.

"Having been with the company since its first year, I am awed and inspired to be part of the team that is bringing this amazing futuristic technology to life," said Donisi Chief Medical Officer Dr. Sagi Polani. "This is an exciting step in our path to fulfilling our mission of changing lives without changing lifestyles. As we move forward, I can envision how our medical device will bridge the continuum of care from hospital to home, impacting lives and health," he continued.

"Chartered Group’s investment in Donisi Health indicates our belief in its development of the innovative optical sensing system that would contribute to resolve various challenges in the healthcare market including the silver tsunami and shift from hospital care to home care," said Eyal Agmoni, Chairman of Chartered Group Technology Division, Donisi’s lead investor, and Managing General Partner of Japan Israel High Tech Ventures 2. "The medical market’s response to this development has been extremely enthusiastic and we are excited with the progress made by such a dedicated team of experts."

For more information or to request an interview, please reach out to Donisi Health