Medtronic to split diabetes business into separate entity, targets IPO
The separation will serve to create an 'independent, scaled leader in diabetes' that boasts an ecosystem of insulin management devices including pumps and continuous glucose monitors, Medtronic said.
The split will also in turn create a wholly 'more focused' Medtronic, with a more simplified portfolio in high margin growth markets.
Medtronic's shares on the New York Stock Exchange (NYSE) fell by 2.27% at market close following the announcement on 21 May.
'It's going to give Medtronic some significant capital to increase their presence in other, more interventional, areas, especially in cardiovascular. They have a history of inorganic expansion, so I can see this as providing ammunition for a big acquisition in 2026-7,' said Dr Andrew Thompson, director of therapy research and analysis in medical devices for GlobalData reacting to the separation.
With a preferred path of an initial public offering (IPO) and subsequent split-off, Medtronic anticipates the split to complete within 18 months through a series of capital markets transactions.
Medtronic describes the vision for the new diabetes standalone as being a 'scaled, direct-to-consumer' business that is positioned positioned as 'the only company to commercialise a complete intensive insulin management ecosystem'.
In addition, Medtronic anticipates that the separation will enable more focused investment into the new diabetes business's pipeline and manufacturing scale and automation, thereby positioning it for success in Automated Insulin Delivery and Smart MDI as it drives margin expansion over time.
'As for the spin out, it might not remain a spin out for that long. Medtronic recently gained US Food and Drug Administration (FDA) 510k approval on a new CGM sensor that is interoperable with Abbott devices, and both companies have an agreement. Abbott might be wishing to preserve that relationship. I wonder if the standalone company might be something that is a joint venture between the two,' Thompson commented.
Medtronic's diabetes business represented 8% of its total revenues in FY 2025 at around $2.75bn, denoting a 10.7% year over year rise. However, the business unit's performance has recently been hampered by the FDA Class I recall of its MiniMed insulin pump system in 2024, resulting in a dent to consumer confidence amid tightening competition and mounting operational losses for the unit since 2022.
According to a GlobalData market model, in 2024, Medtronic held respective US market share of around 6% and 7.3% in the insulin delivery and glucose monitoring segments.
Medtronic Diabetes, umbrellaed under the wider Medtronic business, currently has 8,000 employees globally, with Que Dallara currently serving as the unit's executive vice president and CEO. Dallara is set to continue in such role once the diabetes unit has spun out.
Medtronic CEO and chairman, Geoff Martha said: 'Active portfolio management is an important lever to delivering on our ongoing growth and success, and this decision shifts the Medtronic portfolio to have intense focus on our highest margin growth drivers where we have our strongest core competencies.
'I'm also excited about what the future holds for the Diabetes business. Que's impressive track record in driving growth and innovation has set Diabetes on a path to continued success, ensuring the needs of individuals with diabetes are met around the globe."
Medtronic anticipates that its diabetes business separation will improve its adjusted gross margin by around 50 basis points, adjusted operating margins by around 100 basis points, and be 'immediately accretive' to adjusted EPS.
"Medtronic to split diabetes business into separate entity, targets IPO" was originally created and published by Medical Device Network, a GlobalData owned brand.
The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
Advancing rare disease trials by overcoming patient recruitment challenges
Next month, clinical development and clinical operations professionals will gather and discuss the current challenges in running clinical trials for orphan drugs and rare diseases at the 3rd Annual Clinical Trials in Rare Diseases (CTRD) meeting in Princeton, New Jersey. The meeting, which will take place 17–18 September, will bring together experts from the pharmaceutical and biotech sectors to discuss, not only the obstacles and solutions to clinical trial operational issues, but also to explore the evolving landscape of clinical trials for rare diseases, with a strong emphasis on innovation, collaboration, and patient-centric approaches. At the same venue, the 3rd Annual Clinical Data Management Innovation (CDMI) will explore ways to streamline data entry and collection at trial sites, make better use of real-world evidence, and address the evolving regulatory environment around clinical data. Both meetings will run in parallel at the same venue in Princeton, New Jersey. The Clinical Trials in Rare Diseases meeting will kick off with a case study on how artificial intelligence (AI) is accelerating rare disease drug development. During the talk, Bruce Bloom, CEO of Fortuity Pharma, will map out processes for pre-IND packages, working with the US Food and Drug Administration (FDA), and explore both the challenges and successes of applying AI in such trials. At the CDMI conference, a keynote by Jeff Malavasi, Associate Director of Information Security and Data Compliance of the Cambridge, Massachusetts-based biotech Scholar Rock, will focus on the growing cybersecurity challenges created by the digital transformation of clinical trials. His talk will also provide a practical framework for adopting AI-driven security solutions, including zero-trust architectures and automated response protocols, to safeguard sensitive clinical data. Building on the theme of AI, Aamir Jaka, Global Vice President of the clinical analytics company Saama, will laterexplore how agentic AI is moving data management beyond traditional rule-based automation. Patient recruitment is a persistent challenge in rare disease research On the same day, Jamie Switzer, Associate Director of Clinical Operations at Insmed, will present a case study on strategies to keep trials on schedule while tackling the issue of patient recruitment. Earlier this month, Insmed's drug Brinsupri (brensocatib) was approved to treat non-cystic fibrosis bronchiectasis by the FDA based on results from the Phase III ASPEN (NCT04594369) and Phase II WILLOW (NCT03218917) studies. Switzer will provide practical solutions to patient recruitment problems, while a subsequent panel discussion featuring industry leads from Alexion, Insmed, Asklepion Pharmaceuticals, and BioMarin will take the conversation further to discuss innovative ways to engage patients. Patient recruitment and patient advocacy will be a recurring theme throughout the conference, with speakers sharing insights and emphasising the importance of having patient advocacy organisations as an indispensable partner to extend trial reach, co-design protocols, and foster genuine patient-centered practices. Patient centricity will also be a key theme in the CDMI meeting, where Dinesh Pillaipakkamnatt, former Director of Merck & Co, will highlight how to create a more personalised trial experience, while also considering data privacy, adoption barriers, and the safe handling of large volumes of sensitive information. Tackling operational challenges with clinical trials The second day of both meetings will commence with interactive roundtable discussions on topics such as importance of decentralising rare disease trials, strategies to overcome patient retention barriers, best practices for managing external data and addressing issues of identity, integration, and privacy while enabling patient-centric data management, across both the conferences. The patient and caregiver perspective with rare disease research will be explored with Leigh Dallow, Patient Advocate & Caregiver, sharing her experience around trial participation, discussing trial enrollment decisions, and patient burden, in the CTRD meeting. In a subsequent session, an expert from the Rare Disease Diversity Coalition will discuss the issues of inclusion and diversity in rare disease trials, focusing on underrepresented populations and ways to ensure fair access to therapies and research opportunities. In the afternoon, the focus will shift to the strategic and operational elements of rare disease drug development. In a fireside chat, Bloom and Paul Lupo of PTC Therapeutics will discuss issues such as how to select a CRO and how to work with small patient populations. Another fireside chat, led by Kinjal Patel and Janine Sampong, both with Mitsubishi Tanabe Pharma America, will examine how to accelerate timelines when working with clinical sites and propose strategies to attract attention of academic organisations, and build strong partnerships. Concurrently, the second day of the CDMI meeting will feature several sessions on successful strategies for CDM vendor selection and outsourcing models, an important update on ICH E6(R3) guidelines and its implications for clinical data management, and the implications of AI and machine learning for clinical data management. The meeting will conclude with a case study on CRO and sponsor collaboration, emphasising the importance of improving partnerships and aligning financial incentives. The 3rd Annual Clinical Trials in Rare Diseases and the 3rd Annual Clinical Data Management Innovation conferences are hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena and Pharmaceutical Technology. Click here to read the agenda for the conference for 3rd Annual Clinical Trials in Rare Diseases and the 3rd Annual Clinical Data Management Innovation. "Advancing rare disease trials by overcoming patient recruitment challenges" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 hours ago
- Yahoo
PET imaging gains momentum while SPECT maintains strength in nuclear medicine
Nuclear imaging is entering a period of notable change. Positron emission tomography (PET) scans are gaining traction in oncology and other high-value applications, driven by innovations in tracer development, theranostics, and advanced imaging technologies. According to leading data and analytics company GlobalData's market analysis, the global PET imaging agent market is valued at $2.1bn in 2025, compared to $4.7bn for single-photon emission computed tomography (SPECT). Between 2025 and 2035, PET agents are projected to grow at a compound annual growth rate of 4.6% in market value and 4.7% in procedure volume, a rate 5.5 times higher than the projected growth of SPECT agents. PET growth is primarily driven by tracer innovation, with recent successes in prostate-specific membrane antigen-based scans and clinical fibroblast activation protein inhibitors demonstrating how PET can directly influence treatment decisions. Advanced PET imaging in Alzheimer's disease also holds promise for improving early detection and monitoring of disease progression. The rise of theranostics, which integrate diagnostic PET tracers with therapeutic radioligands, strengthens the PET value proposition by linking imaging with treatment. Emerging tools such as AI-based image quantification and standardised reporting are also expected to improve scan consistency and reduce variability in interpretation, further increasing PET's role in advanced clinical care. These capabilities are encouraging broader adoption of PET across both diagnosis and therapy planning. Comparatively, SPECT remains a key modality in nuclear medicine, supported by established supply chains, low equipment costs, and a longstanding use in cardiology and general nuclear medicine. Technetium-based SPECT scans account for the majority of nuclear medicine procedures worldwide, estimated at 76% in 2025 and projected to hold strong at 70% in 2035. In many regions, particularly those with limited infrastructure, SPECT will remain the practical and reliable choice. Looking ahead, the nuclear imaging market pipeline reflects this shift towards PET usage and development. GlobalData's Pipeline Products Database tracks 129 PET agents in active development compared to 14 for SPECT. Among these, one SPECT agent and seven PET agents are in the approval process and are likely to launch in 2025-26. PET adoption is accelerating, particularly in high-income markets, and is poised to capture a growing share of the global nuclear imaging market, especially in high-value applications. Meanwhile, SPECT will continue to provide accessible and reliable coverage in routine clinical practice. Companies that focus on diversifying tracers, securing supply chains, and aligning strategies with regional infrastructure needs are likely to be best positioned to capitalise on this ongoing transition. Challenges, including radioisotope supply fluctuations, training demands, and variations in global access may influence adoption across specific markets. "PET imaging gains momentum while SPECT maintains strength in nuclear medicine" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio

Associated Press
2 hours ago
- Associated Press
Leading Researchers Reject FDA's Position, Find No Evidence of Harm From 7-OH in Response From Shaman Botanicals to FDA
Shaman Botanicals has issued a formal response to the FDA's recent warning letter on its 7-hydroxymitragynine (7-OH) products, backed by reports from leading researchers at Johns Hopkins, Harvard, UCLA, and other institutions. The company argues that current scientific evidence supports the safety of 7-OH, directly countering FDA's claims. Experts consulted — including those previously cited by FDA — stress that 7-OH should not be considered a public health crisis and that available data shows no evidence of overdose deaths, respiratory depression, or widespread dependence. The experts also emphasize that 7-OH is a naturally occurring kratom-derived compound, not synthetic, and that preclinical studies commissioned by Shaman found no serious toxicity. Collectively, the findings point toward a favorable safety profile and call for continued study rather than scheduling. Shaman Botanicals maintains its commitment to scientific transparency and consumer safety, urging FDA to follow the science. Key Points See the full Shaman Botanicals, LLC response below: Shaman Botanicals, LLC Responds to FDA Warning Letter with Scientific Reports by Renowned Experts Shaman Botanicals, LLC, a leading innovator in botanical wellness, has formally responded to a recent warning letter from the U.S. Food and Drug Administration (FDA) regarding its 7-hydroxymitragynine (7-OH) products. In support of its mission and to defend its products, attorneys for Shaman Botanicals have assembled an interdisciplinary team of renowned researchers, scientists, and clinicians to prepare reports that directly address the FDA's claims concerning 7-OH. 'The FDA asserts that there is insufficient information about the safety of our 7-OH products. However, the scientists consulted by our legal team have found that the evidence to date supports the safety of our products,' stated Stephen 'Vince' Sanders, II, founder of Shaman Botanicals. Scientists Cited by the FDA Express Concerns About the Scheduling of 7-OH Scientific reviews were provided by Dr. Kirsten Smith, PhD, widely regarded as the leading clinical researcher on kratom in the United States and an Assistant Professor at Johns Hopkins University, and Dr. Edward Boyer, MD, PhD, a Harvard-educated medical toxicologist with extensive experience in kratom research. The support for further study and regulation of 7-OH products by Drs. Smith and Boyer reflects a growing and dynamic shift in the scientific community's perspective on 7-OH. Work by Drs. Smith and Boyer was cited by the FDA in their recent report recommending the scheduling of 7-OH. Both Drs. Smith and Boyer are currently leading projects to better understand 7-OH use patterns in the United States. But, having looked at the latest data, they do not agree with FDA's position. Other scientists cited in Shaman's response to the FDA include Dr. Michael Levine, MD, a medical toxicologist educated at Chicago Medical School and an associate professor at the University of California-Los Angeles, recognized for his research in botanical toxicology, and Dr. Jackob Moskovitz, a Technion-Israel Institute of Technology-trained biochemist and internationally recognized expert in molecular biology. Drs. Levine and Moskovitz were provided with three preclinical studies commissioned by Shaman and asked to comment on them. Shaman's response also cited Dr. Glenn Prestwich, PhD, a Stanford-educated chemist and internationally recognized authority on natural products chemistry and chemical biology, and Dr. Andrew Monte, MD, PhD, the Associate Director of the Rocky Mountain Poison & Drug Center in Denver, Colorado, and an expert in nationwide monitoring for adverse events from opioids. 7-OH Should Not Be Considered a Public Health Crisis Dr. Smith strongly disagrees with the FDA's recent recommendation to schedule 7-OH. According to Dr. Smith, the use of 7-OH does not constitute a public health crisis. Furthermore, Dr. Smith asserts that, much like kratom, 7-OH currently offers a net benefit to its users. According to Dr. Smith, who estimates that at least 4 million adults have tried 7-OH, there are no confirmed human cases of respiratory depression caused by 7-OH. Additionally, reports of physical dependence or substance use disorder related to 7-OH are even rarer than those associated with kratom. 7-OH Is Not Causing Widespread Illness or Injury Dr. Boyer reviewed nationwide toxicology databases, including poison center data, and found limited evidence of acute overdose risk from 7-hydroxymitragynine. No deaths have been attributed to 7-hydroxymitragynine, a finding confirmed by America's Poison Center in their August 12, 2025 report. As Dr. Boyer stated, 'A signal arising from overdose death from 7-hydroxymitragynine is absent. Based upon data available at this time, given the degree of population exposure, the lack of findings suggests that 7-hydroxymitragynine carries no unreasonable risk of overdose death.' Dr. Monte arrived at the same conclusion as Dr. Boyer, that there is currently no evidence of a safety signal regarding 7-OH as reported by independent poison control and toxicology centers across the United States. Dr. Boyer also disagreed with the FDA's report regarding the putative safety or danger of 7-OH. According to Dr. Boyer, the FDA assessment relies on animal studies receiving intravenous 7-hydroxymitragynine (a route of administration never used in humans) and overlooks existing data indicating low bioavailability, rapid clearance, and poor brain penetration characteristic of oral 7-hydroxymitragynine. 7-OH is a Natural Product; Not Synthetic Opponents of 7-OH often mistakenly label these kratom-derived products as 'synthetic.' According to Dr. Prestwich, '7-OH is not manufactured synthetically.' Instead, 7-OH is a naturally occurring selective oxidation product of mitragynine, already present among the indole alkaloids in kratom plant extract. These products contain 7-OH that is chemically identical to the natural metabolite of mitragynine produced by the kratom plant and through metabolism in the human body. Thus, 7-OH is a natural product. Pre-Clinical Data Conducted by Shaman Botanicals Supports the Favorable Safety Profile of 7-OH Drs. Levine and Moskovitz each reviewed three preclinical studies commissioned by Shaman: (1) 'Acute Toxicity Assessment of 7-Hydroxymitragynine in Rodents,' (2) 'Pilot Safety Study of Escalating Doses of 7-Hydroxymitragynine and Mitragynine Pseudoindoxyl Administered Daily for 7-day Intervals to Mature Dogs,' and (3) 'An In-Vitro Pre-Clinical Safety Comparison of Mitragynine and its Oxidative Metabolites: 7-Hydroxymitragynine and Mitragynine Pseudoindoxyl.' In the two animal studies, no serious clinical toxicity or adverse events were observed. Dr. Levine stated these studies support initial safety and warrant further evaluation. Dr. Moskovitz concluded, 'Based on all the obtained data (i.e., in vitro studies, mice and dogs' models), it seems that the therapeutic potency and safety profile of 7HMG are either the same or better compared to mitragynine.' Current Science Supports a Reasonable Basis of Safety and Recommends Continued Study, Not Scheduling Full copies of each expert report have been provided to the FDA. 'The FDA pledged to follow the science. The aforementioned experts, some of the top scientists in the world, maintain the science supports a reasonable basis of safety in our 7-OH products,' said Sanders. Commitment to Transparency and Consumer Safety Shaman Botanicals remains deeply committed to transparency, scientific rigor, and consumer welfare. The company welcomes continued dialogue. About Holistic Alternative Recovery Trust (HART) Holistic Alternative Recovery Trust (HART) is a national nonprofit organization advocating for science-based policy, regulatory transparency, and access to safe, plant-based alternatives to opioids and other pharmaceuticals. 7-hydroxymitragynine (7-OH), a metabolite of mitragynine, the most abundant alkaloid found in kratom, is a new tool being used to combat opioid misuse and improve public health. HART strongly supports robust regulation to mandate that all 7-OH products are manufactured safely, are marketed transparently, and are kept out of the hands of children. Learn more at Media Contact HART Media [email protected] ### SOURCE: Holistic Alternative Recovery Trust (HART) Copyright 2025 EZ Newswire