Lifestyle

Freyja HealthCare’s VereSee™ Device Receives 510(k) Clearance, the First of Many Products

Freyja HealthCare’s VereSee™ Device Receives 510(k) Clearance, the First of Many Products

Freyja Healthcare Brings First-of-Its-Kind 2mm Abdominal-Access Device to Laparoscopic Surgery to Further Innovation in Fast-Growing Women’s Health Market


BOSTON, May 8, 2024 (Newswire.com)
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Freyja Healthcare, an early-stage medical device company focused on developing a robust product portfolio of highly innovative products for women’s health, today announced that its novel VereSee device received 510(k) clearance from the United States Food and Drug Administration (FDA). Clearance from the FDA marks a critical step in enabling Freyja and VereSee — the first and only 2mm, safe abdominal-access video-entry device for laparoscopic surgery — to bring further innovation in the fast-growing women’s health market.  VereSee will reinvigorate a category that has not seen innovation in over three decades.

Founded by Jón Ívar Einarsson, MD, PhD, MPH, and Gaby Moawad, MD, FACOG, Freyja’s mission is to raise the standard of women’s health in both surgical and in-office procedures, enabling physicians to deliver safe and effective care. As the company’s first novel product, the VereSee device features a proprietary design engineered to be simple for the surgeon, safe for the patient, and highly differentiated from the current standard of care. The company now has four products in advanced stages of development, 17 granted patents and 21 pending patents.

“From the beginning, I’ve been impressed with Freyja’s mission to improve gynecologic solutions for women and the providers who take care of them. With this first product, Freyja is bringing  meaningful innovation to a category ready for change,” said Kim Rodriguez, longtime Freyja Executive Chairman and former CEO of Acessa Health. 

There are 4.8 million laparoscopic surgeries performed annually in the United States. Abdominal entry is the most dangerous step of laparoscopic and robotic surgery in women’s health, and in all laparoscopic surgery across all specialty areas. This dangerous step results in one patient death and eight injuries in the U.S. each day[1].

“The standard of care is dangerous and outdated. Initial entry is often done blindly with Veres needles or a 5-12mm optical trocar,” said Jón Ívar Einarsson, MD, co-founder and interim CEO of Freyja. “Damaging the bowel or vasculature because of blind entry can cause significant harm, even death, if undetected.” 

As a part of the FDA clearance process, Freyja performed extensive testing and documentation of the safety and efficacy of the product, validating the company’s confidence in the design of its VereSee product. 

“FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category,” said Gaby Moawad, MD, co-founder and Board Director of Freyja. “However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Freyja.”

Freyja will soon begin initial commercialization of the VereSee device, with broad availability expected in the second half of 2024.

About Freyja Healthcare 

Freyja Healthcare was founded in 2017, has four products in advanced stages of development, 17 granted patents and 21 pending patents, and is engineering a robust product portfolio focused on safe and effective surgical and in-office solutions for women. Founded by two well-respected, minimally invasive gynecologic surgeons, Jón Ívar Einarsson, MD, PhD, MPH, Past-President of AAGL, founder of the Division of Minimally Invasive Gynecologic Surgery (MIGS) at Brigham and Women’s Hospital (BWH) and a Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, and Gaby Moawad, MD, FACOG, Associate Professor of Obstetrics and Gynecology at The George Washington University School of Medicine and Health Sciences (GWSMHS). Drs. Einarsson and Moawad are inventing and building the products they wish they had early in their careers and elevating the standards for products used in women’s health surgical and in-office care. Freyja has raised almost $8 million in seed funding from private and professional high net-worth investors. Learn more at Freyja Healthcare.

[1] Clark NV, Einarsson JI. Laparoscopic entry techniques. In: Minimally invasive surgery in gynecologic practice. De Gruyter 2020.

Contact Information:

Jerry Brecher

[email protected]

Original Source:

Freyja HealthCare’s VereSee™ Device Receives 510(k) Clearance, the First of Many Products

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Lifestyle

Clear Cannabis, Inc. Expands ‘The Clear’ Brand in New Jersey With Kushi Labs

Clear Cannabis, Inc. Expands ‘The Clear’ Brand in New Jersey With Kushi Labs

Announcement Coincides with Major Marijuana Reclassification Announcements from The White House Administration

Clear Cannabis, Inc. Expands ‘The Clear’ Brand in New Jersey With Kushi Labs
Kushi Labs, Inc. Logo
Kushi Labs, Inc. Logo


DENVER, May 8, 2024 (Newswire.com)
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In response to growing consumer demand, Clear Cannabis, Inc. (CCI), a leader in cannabis innovation and quality since 2013, is thrilled to announce the expansion of its popular brand, The CLEARTM to New Jersey through a strategic partnership with Kushi Labs. This collaboration marks a significant milestone as the company introduces its top-tier cannabis products to The Garden State. This marks the 12th state for The Clear and its market expansion. 

Under this agreement, CCI will license its IP formulas, processes, and operational knowledge to Kushi Labs. 

“The CLEAR has consistently set the benchmark for excellence and innovation in the cannabis market,” said Richard M. Batenburg, Jr., CEO of Clear Cannabis, Inc. “Our decision to bring The CLEAR to New Jersey with Kushi Labs is a testament to our commitment to meet consumer demand and deliver unparalleled cannabis experiences.”

The CLEAR’s products are celebrated for their unparalleled purity, potency, and palate-pleasing flavors, setting the industry standard for cannabis product excellence. 

This expansion into New Jersey is driven by a strong market demand and a commitment to making these superior products more accessible to discerning consumers in more states. 

Kushi Labs, known in the New Jersey cannabis sector for its exceptional manufacturing processes, will serve as the licensed partner, ensuring that the same high-quality standards known across the U.S. are upheld. The CLEAR’s entry into New Jersey is anticipated to set new benchmarks in the market for product quality and consumer satisfaction.

“Our partnership with Clear Cannabis, Inc. represents a pivotal development in our mission to offer the best cannabis products to New Jersey residents,” stated Ajay Patel, CEO of Kushi Labs. “The CLEAR’s reputation for quality and trust makes them the ideal partner for us as we look to elevate the cannabis experience in our state.”

This expansion into New Jersey coincides with the Biden administration’s recent announcement to reclassify marijuana as a class-3 drug, easing restrictions on its use and research.

“The reclassification of marijuana by the White House is a significant step towards greater acceptance and accessibility of cannabis products, and The CLEAR is proud to be at the forefront of this movement,” said Batenburg.

About The Clear Cannabis, Inc.:

Since its inception in 2013, The CLEAR (part of Clear Cannabis, Inc.) has been at the innovation forefront of the cannabis industry, offering a diverse range of products from vapes to edibles, pre-rolled joints and more. Known for its exceptional flavors and consistent quality, The CLEAR has become one of the most trusted and awarded cannabis brands in the United States. 

From Mild to Wild and Everything Between, The CLEAR has something for everyone, catering to a wide array of lifestyles and preferences, ensuring a premium experience to be enjoyed by all.

For additional information about Clear Cannabis, Inc. and The CLEAR, please visit https://clearcannabisinc.com/.

About Kushi Labs: 

Founded in 2021, Kushi Labs is a leading Licensed Cannabis Manufacturing facility in New Jersey. Dedicated to becoming the primary supplier for cultivators and dispensaries statewide, the company emphasizes innovation and excellence. By integrating advanced technology, Kushi Labs sets high standards in cannabis manufacturing quality and efficiency. Supported by a diverse team of engineers, scientists, businessmen, and connoisseurs, all united by their passion, Kushi Labs commits to delivering outstanding products and services as an industry leader. 

Contact Information:

Brett Schklar

CMO

[email protected]

3038832449

Related Images


Kushi Labs, Inc. Logo

Kushi Labs, Inc. Logo

Kushi Labs, Inc. Logo


The CLEAR Logo

The CLEAR Logo

The CLEAR Logo

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Clear Cannabis, Inc. Expands ‘The Clear’ Brand in New Jersey With Kushi Labs

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