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EDEN PRAIRIE, Minn. & REHOVOT, Israel - Stratasys Ltd. (NASDAQ: NASDAQ:SSYS) has announced that its Stratasys Direct facility in Tucson, Arizona, has received ISO 13485 certification. This standard is internationally recognized and signifies that the facility meets the stringent quality management requirements for medical device manufacturing. The company aims to expand this certification to its other facilities in Texas and Minnesota.
ISO 13485 certification marks a significant milestone for Stratasys Direct, confirming the safety, precision, and reliability of its 3D-printed components for the medical industry. The certification is expected to facilitate the adoption of 3D-printed components in medical device manufacturing, enhancing innovation, reducing costs, and potentially improving patient outcomes.
Stratasys Direct has long been producing complex geometries and patient-specific components for the medical sector, which are difficult to create with traditional manufacturing methods. The new certification underscores the company’s commitment to adhering to rigorous regulatory standards and supporting the medical industry’s ability to innovate and provide better patient care.
Gurvinder Kahlon, General Manager and Vice President of Stratasys Direct, stated, "ISO 13485 certification is a game-changer for medical manufacturing." He emphasized the company’s dedication to delivering high-quality solutions that meet strict regulatory standards.
The certification is set to strengthen Stratasys Direct’s position as a crucial player in the medical device industry by ensuring consistent quality and expanding market access for its advanced manufacturing solutions. With a market capitalization of $807 million and a strong current ratio of 3.07, InvestingPro data shows the company maintains robust financial health to support its expansion plans. InvestingPro subscribers have access to over 10 additional key insights about Stratasys’s financial position and growth prospects. It also underscores the importance of 3D printing as a tool for medical manufacturers seeking to reduce development times and create highly customized components.
Stratasys Direct will be presenting its enhanced capabilities and dedication to the medical industry at the upcoming MD&M West event, which will take place February 4-6, 2025, in Anaheim, California.
Stratasys is recognized for leading the shift to additive manufacturing with its 3D printing solutions, impacting various industries, including aerospace, automotive, consumer products, and healthcare. Investors anticipating the company’s next earnings report on February 26, 2025, can access comprehensive analysis and Fair Value estimates through InvestingPro’s detailed research reports, available for over 1,400 US stocks. The information regarding Stratasys Direct’s ISO 13485 certification is based on a press release statement.
In other recent news, Stratasys Inc. has been at the center of several significant developments. The 3D printing company recently announced a substantial investment from Israeli private equity fund, Fortissimo Capital. Fortissimo intends to invest $120 million in Stratasys by purchasing approximately 11.7 million newly issued ordinary shares, which will represent about 14% of Stratasys’ ordinary shares. Analyst Troy Jensen from Cantor Fitzgerald maintained a positive outlook on Stratasys, sticking to his Overweight rating and a $12.00 price target for the company.
In terms of earnings, Stratasys reported preliminary adjusted net income for the fourth quarter between $8.1 million and $8.6 million, surpassing the consensus estimate. The company also anticipates delivering positive cash flow from operating activities for the full year 2025.
Stratasys has also secured its role as NASCAR’s sole 3D printing partner, aiming to enhance NASCAR’s design and manufacturing processes for parts and tools. This partnership complements Stratasys’ extended five-year agreement with Joe Gibbs Racing, one of NASCAR’s most successful teams, which has been leveraging Stratasys’ 3D printing solutions for rapid prototyping and production of custom parts.
In another development, Stratasys is collaborating with Baralan, a provider of primary packaging for the cosmetics industry, to revolutionize cosmetic packaging using Stratasys’ PolyJet technology. These are the recent highlights for Stratasys, indicating a period of active growth and partnerships.
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