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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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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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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Designed with an atraumatic shaft, the catheter avoids tissue distension common with rigid catheters, enabling safer, more accurate mapping. Magic Sweep integrates with Stereotaxis’ robotic systems, enhancing precision and workflow as the company develops automated mapping algorithms.

“This FDA clearance marks a pivotal moment for Stereotaxis,” said CEO David Fischel, highlighting plans for multiple upcoming robotically-steered devices.

The company plans a broad commercial launch of Magic Sweep in 2025.

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This update follows an earlier warning about the same issue, which initially cited one serious injury and no fatalities. As of June 27, Baxter has reported 79 serious injuries and two deaths associated with the malfunction.

The Novum IQ pumps, designed for precise fluid delivery in clinical settings, may not consistently deliver intended volumes, posing significant risks to patients. The FDA has urged healthcare providers to remain vigilant and follow updated usage guidelines as it continues investigating the matter.

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The Zoom 7X expands Imperative Care’s aspiration system portfolio, offering physicians a tool designed for enhanced navigation and efficient clot removal, even in complex vascular pathways. The catheter’s ability to self-orient its asymmetric tip aims to optimize aspiration outcomes and streamline procedures from access to reperfusion.

Initial patient cases have already been performed, signaling early clinical adoption. The launch follows direct feedback from physicians seeking improved trackability and performance in difficult anatomies. Combined with the Zoom DuoPort and the continuous dual aspiration technique (CDAT), Zoom 7X is part of a broader effort to make complete reperfusion within 10 minutes a new benchmark in stroke intervention.

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The Grenoble-based company’s UroActive implant is an automated artificial urinary sphincter powered by a MyoElectroMechanical system (MEMS). It autonomously adjusts to patient activity, eliminating the need for manual control and aiming to improve ease of use and quality of life. The implant is placed in the urethral duct in men and bladder neck in women.

Following encouraging early feasibility data and the first female implant last year, SOPHIA2 aims to assess safety and efficacy, with results forming the basis for regulatory submissions in the U.S. and Europe.

CEO Hamid Lamraoui called this a major milestone after more than a decade of development, heralding a new era for SUI treatment.

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The Watchman devices are designed to reduce stroke risk in AFib patients who need alternatives to oral anticoagulants. The latest FLX versions feature enhanced visualization markers, a broader size range, and a polymer coating to support a wider patient population.

This expansion aligns with positive findings from the OPTION trial and expectations Boston Scientific set for H2 2025. Analysts at BTIG say the approval confirms the value of combining LAAC with pulsed field ablation, reinforcing Watchman’s role as a key growth driver.

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The FDA classified all six recalls as Class I, indicating possible serious adverse health outcomes or death. Edwards Lifesciences reported no injuries to date and identified the defect during routine quality inspections before procedures. Customers were immediately notified and instructed to return affected devices.

The recalled devices were distributed globally, and clinical staff should be informed of the issue. No patient follow-up is currently required. Edwards continues to investigate the root cause of the defect.

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