Guided Solutions - Global Executive Search in Medical Devices

04/04/2025

Surmodics, Inc. has fully launched its Pounce XL thrombectomy system for removing clots in 5.5mm–10mm peripheral arteries, following its 510(k) FDA clearance in September 2024. The device, which expands Surmodics’ Pounce thrombectomy platform, enables efficient clot removal without capital equipment or thrombolytics, offering a simpler, less invasive alternative to surgery.

Surmodics president and CEO Gary Maharaj commented: “When minutes matter, physicians appreciate the availability of a readily deployable solution with a track record of dependable and safe results.”

👉 Learn more: https://eu1.hubs.ly/H0j1vz50

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0j1r2t0

Surmodics launches Pounce XL thrombectomy system | Innovation

04/04/2025

SamanTree Medical SA has developed the Histolog® Scanner, a CE-marked and FDA cleared device, that enables rapid high-resolution imaging of fresh tissue surfaces during surgery.

Olivier Delporte, CEO of SamanTree Medical, commented : “The ongoing support of both new and returning investors underscores the remarkable progress we’ve made."

🔗 Full story: https://eu1.hubs.ly/H0j1sYc0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0j1rGK0

SamanTree Medical closed a Series B extension, bringing the total financing round to $20m | Funding

04/04/2025

✅ Restor3d won FDA clearance for its cementless iTotal Identity CR 3DP Porous Total Knee Replacement System, as it prepares for a limited market release in the third quarter of this year. The Identity 3D-printed cementless system is claimed to be built upon its personalised orthopaedics approach, integrating a “patient-matched” design with 3D-printed porous technology.

Congratulations to CEO Kurt Jacobus and the rest of the team. 👏

👉 Learn more: https://eu1.hubs.ly/H0j1rXC0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0j1rcF0

FDA grants 510(k) clearance for restor3d’s cementless knee replacement system | Regulatory Approvals

03/04/2025

Bright Uro received FDA 510(k) clearance for its Glean urodynamic analyser system, which enables wireless, catheter-free urodynamics. Bright Uro aims to provide clinicians with more accurate data and actionable insights to aid in clinical decision-making.

👉 Learn more: https://eu1.hubs.ly/H0h_lQb0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0h_mpB0

Bright Uro wins FDA nod for Glean urodynamics system | Regulatory Approvals

03/04/2025

Median Technologies shared positive results from the pivotal studies of its AI/ML-based computer aided detection and diagnosis SaMD, eyonis™ Lung Cancer Screening (LCS), a key requirement for regulatory submissions in the US and Europe.

🔗 Read more: https://eu1.hubs.ly/H0h_mYh0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0h_mZc0

Study backs Median Technologies’ AI lung cancer screening software | Clinical Trials

02/04/2025

The FDA granted expanded 510(k) clearance for Epitel's REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants and paediatric patients aged one year and above. 👶

📣 Epitel CEO Steve Pacelli said: “Epitel continues to make EEG monitoring accessible and deployable for all communities. This new clearance reflects our commitment to improving brain health across all age groups, demographics, and geographies, ensuring that even the youngest patients receive timely and accurate care.”

🔗 Learn more: https://eu1.hubs.ly/H0hZkvq0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0hYH360

FDA grants expanded 510(k) clearance for Epitel’s wireless EEG system | Regulatory Approvals

02/04/2025

CMR Surgical closed a financing round of over $200 million through a combination of equity and debt capital to support its ambitious growth plans for its Versius Surgical Robotic System. 🤖

🔗 Full story: https://eu1.hubs.ly/H0hZb5l0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0hZ7fF0

CMR Surgical secures more than $200m to accelerate growth | Funding

02/04/2025

A new study has demonstrated the value of Neo Medical’s Force Control technology and pedicle screws in thoracolumbar fusion spine surgery. Neo’s pedicle screws, as facilitated by the company’s Force Control technology, resulted in a screw loosening rate of 2.7% versus 9.2% seen in the control group at the one-year follow-up.

👉 Read more: https://eu1.hubs.ly/H0hYJGK0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0hYHjN0

New study demonstrates benefit of Neo Medical’s spine surgery tech | Clinical Trials

01/04/2025

Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the FDA for its tech, providing an early, non-drug intervention for low bone density.

👓 Read more: https://eu1.hubs.ly/H0hWgwn0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0hWgSQ0

01/04/2025

🥼 JenaValve Technology, Inc.'s ALIGN-AR pivotal trial demonstrated that its Trilogy transcatheter heart valve system is safe and effective for high-risk patients with symptomatic, severe aortic regurgitation, suggesting the Trilogy THV system could provide a valuable treatment option for patients with severe AR who are at high surgical risk.

CEO John Kilcoyne shared: "These expanded data demonstrate consistent performance of the Trilogy System, potentially offering severe aortic regurgitation patients, who are poor surgical candidates, a path to life-saving treatment."

👉 More info: https://eu1.hubs.ly/H0hWgM50

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0hWgN10

01/04/2025

Spectrum Vascular & General Surgery won a strategic investment from private investment firm SK Capital Partners. The amount of the deal was not disclosed. Spectrum intends to use the funds to expand operations and development efforts.

Well done to President Tim Donovan and COO Sharon Klugewicz. 👏

Full story 👉 https://eu1.hubs.ly/H0hWgrz0

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0hWh6y0

31/03/2025

🤝 The acquisition includes the Ally robotic cataract laser treatment system, Lensar’s proprietary Streamline software technology and the Lensar legacy laser system, which all help build Alcon’s femtosecond laser-assisted cataract surgery offering. The deal could reach a value of up to approximately $430 million.

💬 “We are excited for the opportunity to bring Lensar’s unique next-generation technologies and intellectual property into our innovative, market-leading equipment portfolio,” said David Endicott, Alcon CEO.

👉 Learn more: https://eu1.hubs.ly/H0hVgZ80

📰 Follow Guided Solutions to receive the latest news daily and subscribe to our weekly newsletter: https://eu1.hubs.ly/H0hVnjr0