Dive Brief Medtronic will pay Cosmo Intelligent Medical Devices $100 million upfront to expand a partnership that makes Medtronic the exclusive global distributor of Cosmo’s GI Genius platform. GI Genius received de novo clearance in 2021 and uses machine learning to flag regions of interest during a colonoscopy, helping physicians detect lesions, such as polyps or suspected tumors. In addition, Medtronic said it would pay a double-digit royalty on net sales and another $100 million in milestone payments that it expects the partnership to reach by the end of 2024. Dive Insight Medtronic first started working with Cosmo Intelligent Medical Devices, a subsidiary of Cosmo Pharmaceuticals, in 2019. When the Food and Drug Administration cleared GI Genius a few years later, the agency said it was the first device that used machine learning to help clinicians detect lesions in the colon. Now, Cosmo and Medtronic are expanding their partnership, including ...
Dive Brief The Food and Drug Administration received more than 19,600 comments related to its planned changes to the oversight of laboratory developed tests (LDTs). The public comment period closed on Monday. Multiple groups pushed back against plans to increase FDA oversight of LDTs. The American Clinical Laboratory Association (ACLA) is at the forefront of the resistance, submitting a 107-page document that outlines “grave concerns” and urges the FDA to withdraw the proposal. Hospitals and healthcare provider groups, like the American Hospital Association (AHA), also opposed the FDA’s proposal, arguing that the rule would limit patients’ access to tests. Dive Insight The FDA closed the comment period Monday, resisting calls to give affected groups more time to send feedback. The length of the comment period is one of many points of contention. Plans to increase regulatory oversight of LDTs, without gaining additional powers from Congress, have alarmed a spectrum of ...
Drugdu.com expert’s response: Although the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) share a common purpose, they apply to different categories of products, with specific differences in the following aspects: Scope of Application: MDR is a regulation for medical devices: It applies to all medical devices not used for in vitro diagnostics, including surgical tools, medical equipment, implants, etc. IVDR is a regulation for in vitro diagnostic medical devices: It specifically applies to in vitro diagnostic devices, such as reagent kits and equipment used for blood analysis. Classification System: MDR: Implements a new risk-based classification system, detailing medical devices into different levels more comprehensively. IVDR: Introduces a new risk classification rule, which is a significant change for the in vitro diagnostic device industry, especially increasing the scrutiny requirements for high-risk IVD products. Clinical Requirements: MDR: Strengthens the requirements for clinical evidence, demanding manufacturers to conduct clinical assessments and ...
The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
Drugdu.com expert’s response: Exporting pharmaceuticals to Japan involves a complex process with multiple steps, due to the stringent regulatory system of the Japanese pharmaceutical market. Here are the key steps summarized by Dide Medical Trade Network: 1.Understanding Japanese Pharmaceutical Market Regulations Before starting the export process, it is crucial to have an in-depth understanding of Japan’s pharmaceutical regulatory laws. The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are the main regulatory bodies responsible for the approval and supervision of pharmaceuticals. 2.Product Registration and Approval All pharmaceuticals intended for sale in the Japanese market must be registered and approved by the MHLW. This usually involves submitting detailed information about the pharmaceutical, such as clinical trial data, evidence of safety and efficacy, etc. 3.Japanese GMP Certification Japan has strict quality control standards for pharmaceutical production, and pharmaceuticals exported to Japan must be produced in ...
Dive Brief The U.S. Food and Drug Administration decided to withdraw from the Global Harmonization Working Party (GHWP), one of multiple groups working to align international standards for medical devices. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, raised concerns about “divergent harmonization efforts” in a Monday letter to Jinghe Xu, chair of the GHWP and deputy commissioner of China’s National Medical Products Administration. Shuren’s concerns included efforts that do not align with the FDA’s priorities or international best practices and the lack of collaboration with the International Medical Device Regulators Forum (IMDRF), another international standards group. Dive Insight The FDA joined the GHWP in December 2021 with the goal of serving as a bridge between the organization and the IMDRF. At the time, the FDA didn’t realize how divergent the two organizations had become, Shuren wrote. “I would like to see GHWP and IMDRF collaborating ...
The US Food and Drug Administration (FDA) has granted an orphan drug designation to Priothera’s mocravimod for leukaemia patients undergoing a stem cell transplant. The drug is indicated to help improve the outcome of patients with haematologic malignancies following a haematopoietic stem cell transplantation, according to a 27 November press release. Following the designation, the Dublin, Ireland-headquartered biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, have seven years of market exclusivity in the designated indication. Haematopoietic stem cell transplantation, also known as blood and bone marrow transplantation, is used to treat a wide range of blood cancers. There are nearly 60,000 new cases of leukaemia in the US each year. This is the second orphan drug designation for Priothera’s mocravimod. The first, granted in March 2022, was for the treatment of acute myeloid leukaemia (AML) in patients undergoing hematopoietic ...
Dive Brief The Food and Drug Administration will continue to allow medical device manufacturers to make alterations to certain products or manufacturing processes without prior authorization if the changes are due to production limitations or supply chain challenges. The policy is a continuation of COVID-19 pandemic-era changes that eased some requirements on device makers during the crisis. The guidance document, issued Thursday, outlines examples of when companies would not be required to file a premarket application (PMA) or humanitarian device exemption (HDE) supplement, or a 30-day notice, before making changes. While the policy was initially created for the emergency pandemic environment, the FDA wrote in the guidance document that it has “continued to observe supply chain challenges and shortages of medical devices remain widespread.” The agency removed the policy’s expiration date, but it could make revisions in the future. Dive Insight The guidance, first issued in May 2020, was supposed ...
Dive Brief Shortages of medical devices and therapies are compromising patient care by delaying treatment and driving unsafe practices, according to a survey of healthcare professionals conducted by the patient safety nonprofit ECRI and the Institute for Safe Medication Practices. The survey found that supply shortages have caused surgical cases to be rescheduled, postponed or canceled, and that a lack of endotracheal tubes and pulmonary artery catheters is on the cusp of impacting the ability to provide adequate clinical care. ECRI and the Institute for Safe Medication Practices used the findings to call for “long-term, nationally coordinated solutions” to stop persistent shortages. Dive Insight The Food and Drug Administration currently lists 11 medical devices that are in short supply. More than 120 drugs face shortages, according to another FDA list. The tendency for some products to become hard to source, for reasons such as manufacturing problems and rising demand, predates ...
ohnson & Johnson MedTech Worldwide Chair Tim Schmid [Photo courtesy of Johnson & Johnson] Tim Schmid is the new worldwide chair of Johnson & Johnson MedTech and EVP of Johnson & Johnson (NYSE: JNJ)+ following Ashley McEvoy’s announcement today that she plans to resign from the world’s second-largest medical device manufacturer.“We are pleased to have the depth of talent at Johnson & Johnson that allows us to transition to Tim, a respected, results-driven and Credo-based leader,” J&J Chair and CEO Joaquin Duato said in a news release.McEvoy called Schmid “a trusted friend and partner” in a LinkedIn post announcing her resignation. Schmid has worked for New Brunswick, New Jersey-based J&J for three decades, most recently serving as group chair of J&J MedTech Asia Pacific (APAC).“During his tenure, the APAC region has delivered above-market growth and further strengthened our leadership position across multiple businesses,” J&J said. “Mr. Schmid has also been instrumental in elevating the role ...
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