Arterex Tecate opens ISO Class 8 clean room facility

NEWS RELEASE:  Arterex Tecate announces opening of 9,000 sq. ft. ISO Class 8 clean room facility New clean room expands medical device manufacturing capacity and reinforces Arterex Tecate’s commitment to quality, compliance, and customer success. Arterex, a leading global medical device developer and contract manufacturer, proudly announces the opening of its new 9,000-square-foot ISO Class 8…

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Breath Sensor Monitors Fat Metabolism at Home

Scientists in Switzerland have developed a portable breath detector that can accurately measure acetone released into the breath when the body burns fat. The smartphone-assisted device allows patients to monitor their metabolism at home and could help doctors personalize treatment for metabolic diseases such as obesity and diabetes.

Acetone levels in the breath have long been recognized as an indicator of metabolic activity, since its concentration rises when the body shifts from using carbohydrates to fats as the primary energy source. However, accurate measurements have traditionally required bulky and expensive laboratory equipment, while consumer devices have lacked the sensitivity needed to reliably measure acetone, especially at lower concentrations. 

“If we want to make that information available to patients, we need to shrink those technologies into compact, user-friendly devices,” said Andreas Güntner, PhD, assistant professor at ETH Zurich and senior author of the study published today in the Device journal.

To make a compact breath analyzer, Güntner’s team used a chemoresistive sensor that changes its electrical properties in the presence of acetone. These types of sensors are known for their high sensitivity, rapid response, low power consumption, and small size. During each measurement, the accompanying smartphone app coaches users to exhale with the right force and duration, while quality controls can reject improper breaths or contaminated air. This design makes the sensor easy to use while ensuring accurate measurements. 

The breath detector was used to analyze 312 breath samples from 12 healthy adults, with measurements closely matching those obtained using gold-standard mass spectrometry. “These findings show that we have the high performance needed for applications such as clinical studies, where you really want to distinguish these slight differences in fat metabolism,” said Simone Hersberger, graduate student at ETH Zurich and first author of the study. 

The researchers then used the sensor to monitor breath acetone under four metabolic scenarios: light exercise followed by a high-carbohydrate meal, intense exercise followed by a high-carbohydrate meal, a high-fat ketogenic meal, and fasting. Breath acetone levels remained low during light exercise but increased with intense exercise, dropping after a high-carbohydrate meal. Acetone levels rose after a ketogenic meal and increased further during fasting. 

Through Alivion, a spin-off from ETH Zurich, the technology is already available to individuals interested in tracking breath acetone to monitor weight loss and athletic performance. The device is currently being used to monitor individual progress in clinical studies of epilepsy, where a ketogenic diet is a standard medical treatment. 

“Now it’s really time to spread it out into clinical trials and answer questions such as the effectiveness of different fasting therapies by providing personalized guidance,” said Güntner. “We’re really moving toward healthcare solutions that, in the future, you won’t need to go to the hospital for anymore. You’ll be able to do them at home.” 

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Using cortical auditory-evoked potential responses to verify the objective benefit of aural rehabilitation in adult cochlear implant users

IntroductionCortical auditory-evoked potential (CAEP) responses are used clinically to assess auditory processing and support cochlear implant (CI) mapping procedures post-implantation. This study aims to examine CAEP responses as an objective measure of neurophysiological changes following a structured Aural Rehabilitation Program (ARP) in long-term adult CI users, with poor baseline speech perception performance. Advancing our understanding of the mechanisms underlying improved post-implantation outcomes in poor performing CI users may inform the development of targeted interventions and refinement of evidence-based rehabilitation strategies.MethodsAdult unilateral CI users with post-lingual deafness were recruited for an intensive clinician-directed ARP incorporating structured active listening exercises. The ARP consisted of weekly 1-h face-to-face sessions over 10 weeks with repeated assessments at baseline (T0) and 10-week intervals (T10, T20, T30). Participants were allocated to immediate (Group 1), 10-week delay (Group 2), or 20-week delay (Group 3) ARP groups, while a control group completed assessments without intensive ARP. Speech perception in quiet [CNC phoneme and word scores (%)] and electrically-evoked CAEP (eCAEP) response [P1-N1-P2 peak latencies (ms) and amplitudes (μV)] measures were collected at each time point for all groups. The repeated measures design incorporated staggered pre- and post-ARP periods for Groups 1–3 (T0-T10, T10-T20, and T20-T30, respectively). CNC and eCAEP measures were analyzed pre- and post-ARP intervention and across assessment intervals (T0-T30) to evaluate rehabilitation effects and account for natural variability and potential ongoing adaptation in auditory performance over time, independent of ARP-related changes.ResultsNo significant changes were observed in eCAEP response latencies or amplitudes from pre- to post-rehabilitation. However, the ARP intervention group demonstrated significantly higher CNC phoneme and word recognition scores compared to the control group in both implant-alone and binaural listening conditions post-rehabilitation.DiscussionNo measurable neurophysiological changes were observed in eCAEP responses from pre- to post-rehabilitation. However, the ARP intervention group demonstrated behavioral improvements, reflected in marginal increases in speech perception scores at both phoneme and word recognition levels, which were not observed in the control group. These findings highlight the clinical value of structured aural rehabilitation in supporting improved outcomes for long-term adult CI users with poor baseline performance.

STAT+: ‘Cochlear implant for blindness’ debuts in Europe, could launch in U.S. in 2027

Europeans can now receive a device that can partially restore their vision loss. Americans may not have to wait long to get it, either.

Science Corporation announced Wednesday that European regulators had approved the commercial sale of the startup’s retinal implant that improves eyesight for patients with age-related macular degeneration in their central vision, enough to read books and road signs more clearly. 

“We have a cochlear implant for vision now,” said Science founder and CEO Max Hodak.

Continue to STAT+ to read the full story…

Medtech CDMO Aptyx names new CEO

Aptyx has promoted CFO David Price to the role of CEO effective immediately, succeeding former Aptyx CEO Gregg Tobin. Price joined the Tempe, Arizona-based medical device contract development and manufacturing organization as CFO in 2025 and is “the right leader to build on Aptyx’s strong foundation and accelerate the company’s continued growth,” said John Pless,…

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AI is moving inside the device. Who owns the clinical risk?

Tips to mitigate the risk that medtech teams keep leaving unowned as artificial intelligence moves into Class II and III medical devices. By Dr. Sarah Matt, Vital Werks By the time a clinician trusts a wrong output from your artificial-intelligence-powered device, every decision that made the trust possible was made years earlier. How many decisions…

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Inside the first-of-its-kind Enable Injections enFuse drug delivery wearable

When Sanofi won FDA approval in July 2026 for the first anticancer treatment administered with an on-body injector (OBI), the Enable Injections enFuse platform made it possible. The enFuse OBI secured its initial combination product FDA approval in 2023 for adults with paroxysmal nocturnal hemoglobinuria, a rare blood disorder. That milestone made enFuse the “first…

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