Pediatric Healthcare News

Related Device Drug Combination Industry News

• In April 2024, Ypsomed partnered with ten23 Health, a globally recognized Swiss contract development and manufacturing organization. This collaboration aims to propel the commercialization of the YpsoDose wearable injector, designed for subcutaneous self-injection of large-volume doses.
• In September 2023, Enable Injections, Inc. secured FDA approval for its EMPAVELI wearable injector (enFuse). This device facilitates the subcutaneous delivery of EMPAVELI (pegcetacoplan). Apellis Pharmaceuticals, Inc. markets EMPAVELI in the U.S. for adults diagnosed with paroxysmal nocturnal hemoglobinuria (PNH).

• May 2024: Dornier Medtech, in collaboration with urologists, introduced Urogpt, an advanced AI tool designed for patients with kidney stones. This launch highlighted Dornier's commitment to digital solutions that prioritize patient needs. Urogpt represented a significant advancement in the company's mission to support individuals with kidney stones. The app provides urology patients with immediate advice and actionable insights, offering clarity and reassurance.
• February 2024: An extracorporeal shock wave lithotripsy (ESWL) machine was inaugurated at INHS Asvini's Urology Department. This advanced ESWL machine offers a non-invasive solution for fragmenting kidney stones, marking a significant improvement in the treatment of kidney stone diseases and patient care at INHS Asvini.

• October 2022: Medtronic introduced a new program called My Insights, which is exclusively made for individuals using the MiniMed 770G system. Using an individual's data, My Insights relies on the power of data science to provide personalized tips, trends, and reminders that customers can use to help with their diabetes management goals. My Insights personalized recommendations are shared via a monthly email with educational content that is most relevant to what an individual may currently be experiencing. This is the first program in diabetes management that goes beyond generalized tips and instead shares personalized suggestions using data from an integrated pump system.
• April 2022: CamDiab and Ypsomed announced the partnership to develop and commercialize an integrated automated insulin delivery (AID) system to help lessen the burden of diabetes management for people with diabetes in European countries. The new integrated AID system is designed to connect Abbott's FreeStyle Libre 3 sensor, the world's most miniature and most accurate continuous glucose monitoring sensor, to CamDiab's CamAPS FX mobile app, which connects with Ypsomed's mylife YpsoPump, creating a smart, automated process to deliver insulin based on real-time glucose data. The connected, smart wearable solution is designed to continuously monitor a person's glucose levels and automatically adjust and have the right amount of insulin at the right time, removing the guesswork of insulin dosing.

• November 2023: Varco Leg Care, a consumer health-tech company, raised a bridge funding round of INR 2 Crore (USD 0.24 million) in the funding round led by the former CEO of Hindustan Coca-Cola, a blend of existing and new investors to advance its mission of revolutionizing leg care across India and the world. The company planned to expand its product portfolio with the introduction of unique topical phyto products for restless legs syndrome.
• April 2023: The United States Food and Drug Administration (FDA) approved de novo status for Noctrix Health’s NTX100 Tonic Motor Activation System for patients with restless legs syndrome. It was considered to be the first therapy to treat moderate to severe drug-refractory restless legs syndrome. The approval was based on the positive outcome of clinical trials. The product is a drug-free, wearable technology developed to activate leg muscles, reduce symptoms, and enhance sleep quality.

• July 2022: Smile Train, Inc. launched the Lifebox-Smile Train pulse oximeter with their long-standing partner Lifebox to scale up access to pulse oximetry for anesthesia and critical care.
• July 2022: Omron Healthcare announced its latest advancement in the oxygen therapy category with the launch of a portable Oxygen concentrator. It is a medical molecular sieve-based concentrator providing a continuous supply of high-purity oxygen.

• August 2022: Medtronic launched a drug-eluting coronary stent, the Onyx Frontierdrug-eluting stent (DES), following recent CE Mark approval. The Onyx Frontier DES offers an innovative delivery system and builds upon the acute performance and clinical data from the Resolute Onyx drug-eluting stent. The device is available in the entire Europe including Germany.
• March 2022: Cathi Distribution GmbH, a company specializing in endovascular simulators, launched the Cathis RHC 2, the company’s next-generation suitable heart catheter (RHC) simulator, in many countries of Europe, including the Netherlands.

• March 2023: Astellas Pharma announced that it has entered into an agreement with Roche Diabetes Care China for the development and commercialization of Roche Diabetes Care's world-renowned Accu-Chek Guide Me blood glucose monitoring system with advanced accuracy as a combined medical product with BlueStar. BlueStar is an FDA-cleared digital health solution for diabetes patients developed by Welldoc and is currently marketed in the U.S. and Canada. Astellas and Welldoc are jointly developing BlueStar in China. In the future, Astellas will aim to obtain regulatory approval and reimbursement as a combined medical product.
• March 2023: Novo Nordisk announced headline results from the PIONEER PLUS trial, a phase 3b, 68-week, efficacy and safety trial with once-daily oral semaglutide 25 mg and 50 mg versus 14 mg as an add-on to a stable dose of 1–3 oral antidiabetic medicines in people with type 2 diabetes in need of treatment intensification. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in HbA1c at week 52 with both the 25 mg and 50 mg doses versus the 14 mg dose of oral semaglutide.

• August 2022: Otsuka Pharmaceutical Factory, Inc. launched an intermittent urological catheter OT-Balloon Catheter. This product is a reusable catheter, and it offers self-catheterization for people having difficulty in urinating spontaneously for various reasons.
• July 2022: Medtronic recalled 1.0 million Class I dialysis catheters at risk of leaking. According to the FDA's recall database, the recall covered 1,019,414 hemodialysis catheters manufactured by Medtronic subsidiary Covidien. It spanned several models of nine separate catheters marketed under the device maker's Palindrome and Mahurkar product names. More than half of the affected devices are labeled as Palindrome Chronic Catheters.

• February 2023: GSK announced that the United States Food and Drug Administration (FDA) has granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with recurrent or advanced mismatch repair-deficient endometrial cancer (dMMR) as determined by the United States FDA.
• March 2022: The Food and Drug Administration has approved pembrolizumab (Keytruda, Merck) as monotherapy for patients with advanced endometrial cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have progression disease after prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

• August 2023: Kakao Healthcare, a subsidiary of Korea’s internet conglomerate Kakao, signed a business agreement with Novo Nordisk, a Danish multinational healthcare firm, to provide smart healthcare services for Korean patients with diabetes.
• June 2023: Novo Nordisk entered exclusive negotiations for a controlling stake in BIOCORP, which would be followed by a mandatory simplified tender offer on all remaining outstanding shares in BIOCORP. BIOCORP is a French company specializing in the design, development, and manufacturing of delivery systems and innovative medical devices, including Mallya, a Bluetooth-enabled smart add-on device for pen injectors.