Strategy

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.

This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.

Getinge says it plans to pay about $477m for organ transport and services company Paragonix Technologies in an effort to “redefine the market standard in transplantation.”

Moximed aims to accelerate adoption of its MISHA Knee System, De Novo-approved by the US FDA in April 2023, with $91m in Series D funding. Chris Gleason, president and chief executive officer, offers perspective on the company’s innovative technology and commercial growth activities.

Announced in conjunction with a $97m Series D financing round, Neptune underscores its gastrointestinal focus and robotics aspirations by spinning out Jupiter Endovascular, which will leverage $21m of the funding to support ongoing development of its Endoportal Control technology.

Following FDA clearance of its Edison Histotripsy System in October 2023 for the non-invasive destruction of liver tumors using focused ultrasound, HistoSonics announces plans for $102m in new funding led by Alpha Wave Ventures. “Bubbles have never been so powerful,” the company says.

The nonprofit XLerator Network has announced eight life sciences start-ups, including five medtech concerns, that will benefit from its educational support and other resources. The NIH-funded program is designed to build entrepreneurial skills and promote commercialization of academic technologies in the US Southeast region. 

MindMaze seeks to create a beautiful immersive experience for patients recovering from brain injuries. Chief medical director John Krakauer, clearly a “Star Wars” fan, discusses the significant need for digital therapeutics at a time when therapists are in short supply, as well as the challenges facing the DTx space as a whole.

This week, Medtronic recalled a nerve monitoring system due to reports of false responses. The US FDA approved the first auto-injector for opioid-overdose, made by Purdue Pharma. The agency granted de novo authorization for Labcorp’s PGDx elio plasma focus Dx used by labs for genetic profiling. As of 7 August, 950 AI/ML devices have been approved by the FDA. EKO Health teamed up with LSU to help detect arrhythmias and murmurs in student-athletes.

Medtronic and Abbott announced partnership to integrate Abbott’s CGM sensor with Medtronic’s insulin pump, which marks a major departure from Medtronic’s former “closed-system” approach. Medtronic also announced FDA clearance of its Simplera CGM, paving the way for its use in smartpens.

In an interview with Medtech Insight, Matt Bettonville, investor at cancer-focused venture firm Yosemite, discussed its criteria for evaluating potential investments in oncology and his outlook on the future oncology landscape.