Strategy

Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.

This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.

Massachusetts-based Harbinger Health has partnered with Memorial Sloan Kettering Cancer Center in New York to accelerate the validation of its AI-driven blood test for early-stage cancer detection. The company also recently presented encouraging data at two conferences.

France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.

The company has taken the ambitious approach of establishing a manufacturing base capable of producing millions of devices before any attempt at a regulatory submission.

At HLTH 2024, GE HealthCare unveiled CareIntellect for Oncology, a generative AI-driven platform to help oncologists quickly assess patient data across multiple sources to save time and improve treatment planning. The platform, currently in evaluation at two US hospitals, is set for launch in the second half of 2025.

Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.

Craig Eagle, chief medical officer of Guardant Health, provides his view on an increasingly competitive liquid biopsy market in this interview with Medtech Insight.

The EU Artificial Intelligence Act, the first official AI regulation globally, entered into force on 1 August 2024. Two months on, Medtech Insight sits down with AI diagnostic startup Owkin’s chief diagnostic officer Meriem Sefta, and senior vice president of public affairs and impact Yedidia Levy-Zauberman, to discuss how the company is adapting to the EU AI Act, the opportunity it presents, and what is needed next for AI deployment in the EU.

Abbott’s Diabetes Care Division has recorded meteoric growth over recent years. Partnerships and a laser-focused strategy for driving patient access are at the core of its success, says Chris Scoggins, SVP of commercial operations and marketing.

At this year’s LSX Nordic conference, experts from Baxter, Philips and Novo Nordisk described key attributes they look for when selecting companies for partnerships or acquisitions and provided advice to founders on how and when to start positioning their start-ups for such opportunities.

Industry experts believe the future of medtech will be centered around patients and their data. To thrive, medtech companies must integrate themselves more organically in the patient continuum and adopt more of a Big Tech mindset in order to meet users' evolving expectations.

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document gives useful insights.

Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston. 

Clue Plus members will have access to 50% off a Headspace subscription for tailored guidance, support and validation to help manage cycle-related stress and improve overall well-being.

Edwards Lifesciences’ Critical Care business “invented the hemodynamic monitoring category, and its solutions are currently used in more than 10,000 hospitals globally to better understand the cardiovascular condition in real-time for critically ill patients, which helps improve outcomes,” says BD, which sees synergies and new innovation opportunities across the groups’ data sets and platforms. Acquired for $4.2bn cash, Critical Care generated more than $900m in revenue in 2023.

During a tour of Truvian’s San Diego headquarters, Medtech Insight spoke with the company’s top executives about their unique three-in-one blood-testing benchtop system, plans for FDA regulatory filing, and marketing strategy.