Medical Device Developments Weekly

Medical Device Developments Weekly

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Medtronic reports improved glycemic control with Smart MDI system in real-world study

The study analysed data from 1,852 individuals with type 1 diabetes across Europe. It found that those who acted on more than 75% of missed dose or high glucose alerts achieved an average Time in Range (TIR) of 67.2% and 71.5%, respectively.

The findings highlight the potential of the Smart MDI system, which integrates the InPen smart insulin pen with the Simplera continuous glucose monitoring (CGM) sensor.

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Sibel Health secures FDA approval for ANNE One platform

🖥️ Sibel Health secures FDA approval for ANNE One platform

The FDA approval includes alarms and alerts, alongside a central station, and makes ANNE One align with the IEEE SDC 11073 standard.

In addition to the approval, the company has secured $30m in new equity financing, led by existing investors Steele Foundation for Hope and Dräger

Steele, which previously led Sibel’s Series B round, contributed an additional $20m, while medical and safety technology firm Dräger added $10m to its previous Series A investment.

Sibel plans to use the funding to deploy its platform, which features advanced wearable sensors for wireless monitoring of vital signs in patients aged 12 and older.

Read more online: https://lnkd.in/et7nqh-a

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The FDA approval includes alarms and alerts, alongside a central station, and makes ANNE One align with the IEEE SDC 11073 standard.

In addition to the approval, the company has secured $30m in new equity financing, led by existing investors Steele Foundation for Hope and DrägerSteele, which previously led Sibel’s Series B round, contributed an additional $20m, while medical and safety technology firm Dräger added $10m to its previous Series A investment.

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Clarius Mobile Health AI-Powered Ultrasound Now Enables Plastic Surgeons to Quickly Master Ultrasound Breast Anatomy for In-Clinic Exams

🍈 Clarius Mobile Health AI-Powered Ultrasound Now Enables Plastic Surgeons to Quickly Master Ultrasound Breast Anatomy for In-Clinic Exams 

Clarius developed the training tool to help address the growing demand for clinicians skilled in conducting breast exams. While the FDA recommends that breast implant patients undergo ultrasound breast exams every two to three years, the shortage of skilled sonographers has created long wait times for patients. 

Many plastic surgeons are using ultrasound in their practice and seek training to increase their proficiency with reading grey scale images, which are notoriously difficult to interpret for new users. 

Dr. Marc Salzman, a double board-certified plastic surgeon and ultrasound educator who published a paper on the benefits of using ultrasound for breast implant surveillance helped test the new feature during its development and says “Clarius T-Mode for breast is very helpful in teaching breast ultrasound and will help novice physicians ad

Clarius developed the training tool to help address the growing demand for clinicians skilled in conducting breast exams.

While the FDA recommends that breast implant patients undergo ultrasound breast exams every two to three years, the shortage of skilled sonographers has created long wait times for patients. Many plastic surgeons are using ultrasound in their practice and seek training to increase their proficiency with reading grey scale images, which are notoriously difficult to interpret for new users.

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GE HealthCare unveils AI-powered Invenia ABUS Premium for breast cancer screening

🍋 GE HealthCare unveils AI-powered Invenia ABUS Premium for breast cancer screening

The new system is designed to enhance breast cancer screening, particularly for patients with dense breast tissue. It aims to optimise scanning efficiency and support early detection efforts by streamlining imaging procedures and accelerating clinical workflows.

The ABUS Premium integrates AI-powered Verisound tools, including Scan Quality Assessment, which enables immediate evaluation of breast coverage and positioning during the exam. It also features Auto Nipple Detection, ensuring consistency in nipple marker placement.

A Fast Scan function increases scanning speed by up to 40% compared to its predecessor, Invenia ABUS 2.0, while the cSound Imageformer technology enhances image clarity by automatically adjusting focus at every pixel.

Read more online: https://lnkd.in/eVB59qsR

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The new system is designed to enhance breast cancer screening, particularly for patients with dense breast tissue. It aims to optimise scanning efficiency and support early detection efforts by streamlining imaging procedures and accelerating clinical workflows.

The ABUS Premium integrates AI-powered Verisound tools, including Scan Quality Assessment, which enables immediate evaluation of breast coverage and positioning during the exam. It also features Auto Nipple Detection, ensuring consistency in nipple marker placement.

Read more


Medit and Pearl partner to enhance AI-powered dental diagnostics

🦷 Medit and Pearl partner to enhance AI-powered dental diagnostics

This integration aims to enhance intraoral scanning by combining Medit’s precise imaging technology with Pearl’s AI expertise. The partnership is set to improve diagnostic accuracy in dental practices and facilitate more effective communication with patients about their oral health conditions.

The Medit Link platform serves as a centralised system for dental clinics and laboratories, designed to streamline digital workflows, from intraoral scanning to patient communication.

With Pearl’s AI-powered diagnostics, dental professionals can now identify oral conditions such as teeth misalignment, cracks, calculus, and discolouration more efficiently. 

This integration promises to standardise diagnostic processes, boosting patient confidence and encouraging necessary treatments to improve oral health.

Read more online: https://lnkd.in/eVWPsf4K

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This integration aims to enhance intraoral scanning by combining Medit’s precise imaging technology with Pearl’s AI expertise. The partnership is set to improve diagnostic accuracy in dental practices and facilitate more effective communication with patients about their oral health conditions.

The Medit Link platform serves as a centralised system for dental clinics and laboratories, designed to streamline digital workflows, from intraoral scanning to patient communication.

Read more


Synchron unveils roadmap to Cognitive AI with Chiral brain model

🧠 Synchron unveils roadmap to Cognitive AI with Chiral brain model

The company is advancing BCI from supervised to self-supervised learning by integrating large-scale neural data with NVIDIA’s AI-powered computing capabilities.

Synchron showcased its AI-enabled BCI, powered by the NVIDIA Holoscan platform, on the Apple Vision Pro at the GTC 2025 event.

The technology allows users to control digital and physical environments using Synchron’s Stentrode direct thought-control technology.

Synchron CEO and founder Tom Oxley said: “We are building a brain foundation model using generative pre-training techniques that learn directly from neural data—abstracting human cognition at its source – to create features that improve our user’s lives.

“This is possible because of our ability to scale large datasets, by making BCI as common as a stent insertion.”

Read more online: https://lnkd.in/ePgeneKE

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The company is advancing BCI from supervised to self-supervised learning by integrating large-scale neural data with NVIDIA’s AI-powered computing capabilities.

Synchron showcased its AI-enabled BCI, powered by the NVIDIA Holoscan platform, on the Apple Vision Pro at the GTC 2025 event. The technology allows users to control digital and physical environments using Synchron’s Stentrode direct thought-control technology.

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