Leach, a 21-year Dexcom veteran, has been instrumental in developing multiple generations of the company’s continuous glucose monitoring (CGM) systems, including the G7 and Stelo. His leadership marks a strategic continuation of Dexcom’s innovation-driven trajectory.

Sayer, who has served as CEO since 2015, will remain actively involved as executive chair of the board after the transition. The move is part of Dexcom’s planned succession strategy, aligning leadership continuity with long-term growth.

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Designed for adults who haven’t responded to conventional therapies like biologics or targeted DMARDs, the system activates the body’s natural anti-inflammatory pathways—offering a novel alternative to immunosuppressive drugs. Implanted during a simple outpatient procedure, it delivers therapy automatically on a preset schedule to ensure patient compliance.

Backed by data from its RESET-RA trial and supported by the FDA’s TAP program, the device could also be adapted for other autoimmune conditions like multiple sclerosis and Crohn’s disease.

A limited U.S. launch begins this year, with national rollout expected in early 2026.

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In parallel, InspireMD named Raymond W. Cohen—former CEO of Axonics and a seasoned medtech executive with multiple billion-dollar exits—to its board. Cohen’s expertise is expected to accelerate InspireMD’s commercial push and strategic expansion.

CEO Marvin Slosman emphasized the company’s momentum: “With a strong balance sheet, national coverage for carotid stenting, and best-in-class clinical data, we are poised to lead the carotid intervention market.”

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Previously cleared for ages five and up, the updated indication makes EvoEndo the only provider of transoral endoscopy for infants using ultra-slim scopes. The company already led in sedation-free, transnasal endoscopy for older pediatric patients.

With ChannelMax technology supporting standard pediatric accessories and scope lengths of 85 and 110 cm, EvoEndo’s system is designed to address a wide range of anatomies and procedures. Its portable platform also enhances care accessibility across diverse clinical settings.

CEO Jonathan Hartmann emphasized the milestone as “elevating care for newborns and infants” while broadening endoscopy access across age groups.

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Unlike traditional CGMs, Sava’s device uses a proprietary multi-molecule sensor that detects biomarkers beneath the skin in real-time. The sensor streams glucose insights directly to the user’s phone and aims to offer a pain-free, longer-lasting alternative.

In a UK-based clinical trial involving 50 patients with type 1 and insulin-dependent type 2 diabetes, early data from 25 participants showed accurate glucose readings for up to 10 days—significantly outlasting many current sensors.

With promising results and fresh capital, Sava is poised to compete in the growing CGM market, emphasizing durability and comfort.

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Boston Scientific, through Farapulse, has pioneered PFA with a non-thermal system that’s gaining strong clinical and regulatory momentum. Meanwhile, Medtronic’s acquisition of Affera is expanding its reach, advancing novel catheter-based PFA solutions now in trials. Johnson & Johnson’s Biosense Webster division is developing Varipulse—an integrated system aimed at enhancing safety and precision in AFib treatments. Abbott is also entering the race with Volt, a next-gen PFA platform now in clinical testing, promising high precision and minimal invasiveness.

Biotronik, with its Centauri system, is gaining traction in Europe through a strategic distribution deal with CardioFocus. Centauri’s customizable monopolar waveform and focal contact force approach position it as a serious contender for widespread clinical adoption.

These companies are shaping what could become the new gold standard in electrophysiology. Who do you think will lead the PFA revolution over the next 5 years?

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Centauri is an open-platform PFA solution designed for focal contact force catheter workflows. It uses a custom monopolar waveform to create transmural lesions while avoiding microbubbles and muscle stimulation, aiming to improve procedural efficiency, safety, and outcomes in cardiac ablation—particularly for paroxysmal atrial fibrillation.

Dr. Andreas Hecker, President CRM/EP at Biotronik, highlighted the collaboration as part of their commitment to advancing electrophysiology innovation and supporting physicians.

CardioFocus CEO Steve Ogilvie praised Biotronik’s expertise and global reach, emphasizing their role in driving Centauri’s growth across Europe.

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The pump software continuously monitors the electrical current through the speaker to ensure proper function. If current measurements fall outside a preset range, the pump declares a “Malfunction 16,” indicating speaker failure. When this occurs, insulin delivery stops, and the pump becomes non-operational.

If uncorrected, this malfunction may lead to hyperglycemia, requiring hospitalization or medical intervention.

Users are advised to monitor pump alerts closely and contact Tandem Diabetes Care for support if Malfunction 16 appears.

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The study assesses the safety and effectiveness of Infuse in patients with degenerative lumbar spine conditions, testing two dose levels and compatibility with PEEK and titanium cages. This adaptive design and reduced sample size amendment, approved by the FDA in April, aim to broaden clinical applicability.

Medtronic is now preparing its premarket approval (PMA) submission and plans to file for new technology add-on payment (NTAP) reimbursement with CMS if approved. Infuse for TLIF holds FDA breakthrough device designation since April 2024.

“Our teams are committed to delivering a high-quality PMA submission and collaborating closely with the FDA,” said Dave Breiter, Medtronic’s VP of clinical and regulatory affairs.

This progress comes eight years after Medtronic settled lawsuits over off-label Infuse use allegations.

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Though the device lockout does not cut or staple, it requires additional steps to safely release and remove it, posing a risk of serious injury or death. Ethicon has reported one death and one injury related to this issue. The design includes safeguards to prevent vessel injury, with staples remaining below the tissue surface and the knife not advancing fully during lockout.

Ethicon advises users to review updated instructions and provides a video demonstration on managing device lockouts. The correction affects specific product lots of the Endopath Echelon Vascular White Reload (35mm, 4-row) with product code VASECR35.

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