MedTech Spectrum

Article Name Medical Devices

GE Healthcare Gets FDA Clearance for Allia IGS Pulse: Next-Gen Cardiac Imaging System

GE HealthCare (Nasdaq: GEHC) announced US FDA 510(k) clearance of Allia IGS Pulse - the latest addition to the company’s image guided system (IGS) offerings. Allia IGS Pulse features a new imaging chain engineered to provide exceptional imaging at the right dose for visible impact in complex cardiology interventions regardless of patient size.

17th October, 2023

Cordis Statement on CMS Expansion of Carotid Stenting Coverage

Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technology, strongly supports the decision made by the Centers for Medicare & Medicaid Services (CMS) to expand coverage of carotid artery stenting (CAS) cms.gov. This expansion in coverage will allow patients that suffer from carotid artery disease expanded access to minimally invasive endovascular carotid therapy.

17th October, 2023

Werfen Secures FDA 510(K) Clearance for Aptiva® Tissue Disease Reagent

New Reagent Aids in Diagnosis of Connective Tissue Disease in Hard-to-Diagnose Autoimmune Diseases, Reducing Time to Diagnosis and Improving Patient Outcomes

17th October, 2023

Shaping the Future of Anaesthesia and Critical Care in India: An Exclusive Interview with Shalin Patel, Managing Director of Draeger India Group

On the occasion of World Anaesthesia Day, MedTech Spectrum & BioSpectrum India delve into the dynamic world of healthcare and technological innovation. We had the privilege of speaking with Mr. Shalin Patel, the Managing Director of Draeger India Group, a prominent player in the medical and safety technology sector.

16th October, 2023

UL Solutions Rolls Out Medical Device Testing in Michigan, Helping the Industry Advance Safety of Healthcare Technology

UL Solutions helps Michigan's growing medical device industry enhance products' safety, security, usability and interoperability with new testing services in Rochester Hills.

13th October, 2023

UltraNav System Enhances Transseptal Procedures for Safety and Cost-Efficiency

Novel platform for structural heart interventions now in human use, with ability to improve patient recovery and reduce anesthesia and hospital stays

13th October, 2023

Brainomix and Nanoflex Robotics to Collaborate on an AI-Assisted Robotic System for Remote Stroke Intervention

Brainomix Awarded Innovate UK Grant to Collaborate with Swiss-based Nanoflex Robotics

13th October, 2023

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.

13th October, 2023

Sigrid Therapeutics Announces First Patient Treated with SiPore21® Medical Device for Sustained Diabetes and Obesity Control

Sigrid Therapeutics announces the commencement of the SHINE clinical trial for SiPore21® – an innovative medical device designed for sustained diabetes and weight control. Based on Mesoporous Silica particles (MSPs), SiPore21® represents a groundbreaking approach to managing these pressing health concerns. Administered orally in gel form, MSPs act as "molecular sieves," physically preventing digestive enzymes from interacting with food, thereby reducing the breakdown of carbohydrates and fats.

11th October, 2023

Promega to develop microsatellite instability companion diagnostic IVD kit in collaboration with GSK

To identify patients with the MSI biomarker who may be eligible for potential treatment with Jemperli

05th October, 2023

Taiwan's medtech startup Flat Medical secures funding for global market expansion

Strategically positioned to accelerate growth and expand presence in key markets across the United States, Europe, and the Asia-Pacific region

03rd October, 2023

Fujitsu and iSurgery launch bone health promotion project in Japan

Project launched with Jikei University School of Medicine aiming for early detection of osteoporosis

03rd October, 2023

Lunit to Present 6 Abstracts on AI Cancer Solutions at SITC 2023 Annual Meeting

Lunit's 6 posters unveil new tumor microenvironment insights and the predictive power of Lunit SCOPE across diverse cancer types at SITC 2023

28th September, 2023

4WEB Medical Receives 510k Clearance to Market New Integrated Cervical Plate

Company Continues to Build Momentum with Most Recent Portfolio Expansion.

28th September, 2023

Saluda Medical Receives FDA Approval for Evoke® System MRI Labeling

Patients implanted with the Evoke® System now eligible for full-body MRI scans

27th September, 2023

Fujitsu and iSurgery Launch Osteoporosis Detection Project with Jikei University

Fujitsu Limited and iSurgery Co., Ltd. announced that they will conduct a field trial as part of their “bone health promotion project” from October 2023 to March 2025 in collaboration with the Department of Orthopaedic Surgery at the Jikei University School of Medicine (1), to verify the practicality of bone assessments (2) conducted with chest radiographs and the effects of this approach in changing Fujitsu employees’ attitudes and habits around health. This marks the first time in Japan that an employer is focusing on the improvement of this aspect of its employees’ health during their examinations through this novel use of chest radiographs for bone assessments.

26th September, 2023