NY-INNOVATIVE-HEALTH
26.8.2021 16:02:07 CEST | Business Wire | Press release
Innovative Health Sciences, LLC (“IHS” or the “Company”) management announced today that IHS has received FDA clearance for its Insignis™ Subcutaneous Needle Sets. This regulatory clearance allows IHS to sell and distribute its subcutaneous needle sets throughout the United States. The FDA clearance comes just weeks after the Company received the CE mark and ISO certifications permitting the sale of the full Insignis™ Syringe Infusion System throughout Europe.
The state-of-the-art Insignis™ Subcutaneous Needle Sets deliver an improved patient experience with reduced pain at a lower cost for the subcutaneous infusion of medications in the home, hospital, ambulatory, or clinic setting. New features include a butterfly-wing channel that maintains the needle at a 90-degree insertion angle, a needle safe-protection design using an audible and tactile wing closure that helps prevent needle stick injuries, and smaller needles. These new Insignis™ Subcutaneous administration sets can be used with typical infusion pump systems cleared for use for the delivery of medications to the subcutaneous tissues.
The 26-gauge subcutaneous needle sets are offered in single, bifurcated, trifurcated, and quad-furcated sets and are offered in 6mm, 9mm, 12mm, and 14mm sizes. “Patients using the Insignis™ needle sets will find that they obtain virtually the same flow as with common 24-gauge needles– but in a smaller, less painful 26-gauge needle,” says Andrew Sealfon, the Company’s Chairman and CTO. “The needle sets are designed and manufactured with features to enhance the patient experience, including the easy to close safety needle design and no-tangle tubing for patient ease of use,” added Sealfon.
The Insignis™ Subcutaneous Needle Sets, available separately, are a subcomponent of the full next generation Insignis™ Syringe Infusion System, which has received CE mark and ISO certifications for European distribution, and is concurrently in process for FDA submission in the United States. The full system includes 5 separate products: infusion pump, IV Controller, (selectable rate flow controller that attaches to a catheter), OneSett™ (subcutaneous selectable rate flow controller combined with subcutaneous needle sets), fixed rate tubing for both intravenous and subcutaneous applications, and subcutaneous needle sets (now cleared for market in the U.S.).
The Insignis™ Syringe Infusion System is the first non-electric infusion pump available with a selectable flow rate controller for both intravenous and subcutaneous routes of administration, providing nearly the performance and accuracy of electronic infusion systems at a fraction of the cost.
Sealfon, Innovative Health Sciences’ founder, is a forty-year investor, innovator, and executive of the medical device industry. Inventor and founder of Repro-Med Systems, Inc. (KORU Medical Systems) and the FREEDOM™ system, Sealfon served as its President, Chairman of the Board, and Chief Executive Officer from September 1982 until July 25, 2018.
About Innovative Health Sciences
New York-based Innovative Health Sciences, LLC provides innovative solutions to the infusion healthcare market. IHS’ approach is patient-centric and future-oriented; our goal is to provide the highest quality of life by empowering the patient to take control of their infusion. For more information on the Company and the products, be sure to check out the new website, www.innohealthsci.com .
Forward-Looking Statements
The statements contained herein are not guaranteed of future performance and undue reliance should not be placed on them. Such Forward-Looking Statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied. These statements are based on management’s beliefs and theory. The Company undertakes no obligation to update Forward-Looking Statements if circumstances or management’s estimates or opinions should change, except as required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210826005364/en/
Link:
Social Media:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Helical Fusion Launches Helix Program “Official Partners” to Build Japan’s Industrial Coalition for Commercial Fusion Energy28.4.2026 05:00:00 CEST | Press release
Multiple long-established Japanese companies join as inaugural partners in a shared push to build the fusion energy industry; Helical Fusion also completed the first close of its Series B round Helical Fusion Co., Ltd., a fusion energy company developing a Helical stellarator power plant, today announced the launch of Helix Program Official Partners, a new strategic partnership framework designed to bring together long-term industrial collaborators committed to advancing fusion from laboratory progress to real-world fusion power deployment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427596284/en/ Helical Fusion’s Integrated Demonstration Device, “Helix HARUKA,” currently under construction (photographed at the company’s dedicated workspace within the National Institute for Fusion Science in Gifu, Japan) The Helix Program is Helical Fusion’s core initiative to realize commercially viable fusion energy in the 2030s. Rat
Investor Supporting Japan’s Entertainment Industry, Yoshihiro Shimamura, to Visit France Workshop to be Held During the Cannes Film Festival28.4.2026 04:00:00 CEST | Press release
Shimamura Yoshihiro Film Planning Inc. (Head Office: Osaka, Japan; CEO: Yoshihiro Shimamura), a company engaged in film production and investment, will host a workshop in France during this year’s Cannes Film Festival, as part of its commitment to further advancing the entertainment industry. The company invests in leading entertainment-related businesses in Japan and places strong emphasis on long-term value creation. It identifies the cultural and entertainment sectors as high-growth areas and is actively involved in international co-productions as a core part of its film production activities. As a recent investment, the company acquired 2,000,000 shares of Hankyu Hanshin Holdings, Inc.—a major Japanese entertainment conglomerate known for producing content enjoyed across generations—and became a major shareholder (as of March 25, 2026). Through such investments, the company aims to support the global expansion of Japanese entertainment while exploring synergies with its own interna
Alsym Energy Announces Na-Series Battery Success Developed With Physics-Informed AI Platform27.4.2026 21:25:00 CEST | Press release
Alsym’s proprietary physics-informed AI platform powered the development of its Na-Series batteries—a non-flammable, high performance and low cost energy solution positioned to serve critical energy storage markets including data centers, utilities, telecommunications, commercial real estate, industrial and defense, among others. Alsym Energy, a pioneer in non-flammable, high-performance sodium-ion batteries, today announced details of the proprietary physics-informed AI platform used to develop the company’s recently launched Na-Series sodium-ion batteries. By integrating fundamental physics models with AI, autonomous testing and proprietary molecular diagnostics in a closed-loop system, Alsym is accelerating the design of safer, inexpensive, commercialized batteries through all phases of the development cycle. As global demand for electricity surges, the limitations of lithium-ion batteries have become increasingly apparent, particularly around safety and supply chain constraints. Li
Backed by Investments Exceeding $1 Billion, PCI Pharma Services Announces Major Expansion of US Sterile Fill-Finish and Drug-Device Delivery Combination Capabilities27.4.2026 16:00:00 CEST | Press release
As pharma manufacturers prioritize US supply chain resilience, highlights include high-speed isolator filling lines for prefilled syringes, cartridges and vials, and drug-device combination assembly and packaging. PCI Pharma Services (“PCI”) – a world-leading integrated global contract development and manufacturing organization (CDMO) focused on innovative biologic and small molecule therapies – announced a series of major infrastructure investments that substantially deepen its sterile fill-finish and advanced drug delivery capabilities. As pharma manufacturers and their development partners increasingly prioritize US supply chain resilience, PCI’s latest investments come as part of a broader commitment exceeding $1 billion across the CDMO’s US and European operations, reinforcing its ability to provide seamless support for drug product development and manufacturing, clinical trial supply and drug-device combination assembly from clinical stages through commercial launch – all underpi
Pure Lithium Appoints Renowned Battery Expert Dr. Yuan Gao to Board of Directors27.4.2026 15:53:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated lithium metal battery technology company, is pleased to announce that world-renowned inventor and battery expert Dr. Yuan Gao has joined the company’s Board of Directors. Dr. Gao has been an invaluable member of Pure Lithium’s Scientific Advisory Board since October of 2023. "We are thrilled to have Dr. Gao join our board as we focus on rapidly scaling our technology in the most capital efficient manner possible,” said Pure Lithium Founder, Chairman and CEO Emilie Bodoin. “Dr. Gao is a brilliant scientist who also has deep commercial expertise, a rare combination. He is also unique in the industry because his experience spans the entire battery materials value chain, including all of Pure Lithium’s verticals. His insights over the years have been critical in advancing our technology, and his experience as a director of public companies will strengthen our board.” Dr. Gao commented: “I am thrilled to join the board of Pure Lithium Corpor
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom