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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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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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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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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TAVR revenue reached $1.1 billion (up 8.9%), while transcatheter mitral and tricuspid therapies soared 61.9% to $134.5 million. Following the strong quarter, Edwards raised its full-year sales growth guidance to 9–10% and EPS to the upper end of $2.40–$2.50.

CEO Bernard Zovighian cited momentum across the company’s aortic, mitral, and tricuspid portfolios, with analysts expecting continued tailwinds from new FDA approvals and market exits by competitors.

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Spectris delivers synchronized light and sound at 40 Hz to stimulate gamma brain waves, disrupted in Alzheimer’s. In the OVERTURE trial and its open-label extension, patients experienced significant delays in cognitive and structural decline — including up to 9.9 months of “time saved” across key clinical endpoints.

MRI analyses showed preservation of white matter and myelin integrity. Patient-reported outcomes also improved, with less decline in areas like independence, communication, and emotional stability. Daily adherence to therapy exceeded 85%.

Cognito aims to establish Spectris as a safe, effective neuromodulation therapy that shifts the Alzheimer’s treatment paradigm.

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The study’s primary endpoint uses a win-ratio approach, factoring in freedom from major amputation, target lesion revascularization, and vessel patency at 12 months. Up to 224 patients will be enrolled across 30 sites, alongside a 1,500-patient registry for those ineligible for the trial.

The first patient was treated at Massachusetts General Hospital by vascular surgeon Dr. Anahita Dua, who emphasized the importance of gathering high-quality real-world data to assess laser-based treatment approaches in this challenging patient population.

Auryon’s solid-state laser technology offers versatility in treating lesions of any type or length with minimal vessel trauma. AngioDynamics says this could mark a pivotal advancement in treating peripheral artery disease, particularly below the knee.

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The decision follows positive results from the LENNY clinical trial, which demonstrated the device’s safety and effectiveness in young children with type 1 diabetes aged 2 to 6 years. Additional data also support benefits for type 2 diabetes patients.

Dr. Fiona Campbell, chair of the U.K.’s National Children & Young People’s Diabetes Network, said the advancement eases the burden of constant glucose monitoring and insulin adjustments, promoting better growth, brain development, sleep, and overall quality of life in children.

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The update affects the Servo ventilator systems, including Servo-u, Servo-n, and Servo-u MR models. It addresses risks related to inaccurate compliance measurements that may cause improper tidal volume delivery in neonatal patients.

Specifically, some humidifiers fail standard leak tests due to their design, prompting the use of an extended leakage test configuration. Incorrect test settings—particularly in hospitals using multiple humidifier types—could cause displayed tidal volumes to differ by up to 50% from actual delivery. This discrepancy poses risks of hypoventilation and hypoxia, especially in premature neonates.

Maquet reports one injury linked to the issue but no fatalities. External monitoring and alarms are expected to detect ventilation problems.

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This issue may lead to severe complications including dura tears, bleeding, brain contusions, irreversible damage, or death. Medline has instructed customers to quarantine affected kits and conduct inventory checks. No injuries or deaths have been reported so far.

The FDA classifies the recall as serious, requiring correction rather than removal from use or sale.

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