Medical Device Developments Weekly

Welcome to this week's Medical Device Developments newsletter.

See the latest insight and analysis from the global medical device market from the last week below:

Hedia, Glooko launch integrated bolus insulin dosing solution in UK

The new interoperable solution combines connected care, remote patient monitoring, and digital therapeutic technologies from the two companies.

Currently launched in the UK, the solution will be extended to other European countries. In April 2023, Glooko and Hedia entered a global collaboration to integrate Hedia’s insulin dosing algorithm into Glooko’s diabetes management platforms.

Ventris Medical gets FDA 510(k) approval for Backpack biomaterial

Backpack, also known as Porous Biologic Scaffold K240765, is an advanced biomaterial designed for the optimisation of cell proliferation and bone formation.

Intended for use in orthopaedic and spinal fusion procedures, the new bone graft containment system is offered in two versions.

KARL STORZ acquires T1V, Inc.’s medical business to enhance digital surgery

T1V has been working with KARL STORZ for years to build the latter’s CollaboratOR portfolio, which has been sold since 2018.

KARL STORZ said that the acquisition will help to shape integrated hardware and software solutions for digital surgery in operating rooms worldwide. The move also complements its advanced endoscopes and medical solutions.

Aiosyn Mitosis Breast becomes the first AI-powered mitosis detection solution to achieve CE mark certification under IVDR

Breast cancer is the most common cancer among women, with 2.3 million new cases diagnosed annually worldwide, including 604,900 in the WHO Europe region in 2022.

Despite significant advancements that have reduced mortality rates in recent decades, breast cancer remains the leading cause of cancer-related death among women in Europe and globally.

Anumana partners with AliveCor to enhance cardiac detection with AI

Under the collaboration, both companies will develop Anumana’s advanced AI algorithms for early cardiac disease detection on AliveCor’s Kardia electrocardiogram (ECG) devices.

The partnership begins with the US Food and Drug Administration (FDA)-cleared ECG-AI LEF algorithm, designed for early cardiac disease detection.

Bayer announces positive Phase 3 results for gadoquatrane MRI agent

Gadoquatrane is an extracellular macrocyclic contrast agent for MRI.The MRI agent was tested at a dose of 0.04 mmol Gd/kg body weight, reducing gadolinium by 60% compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.

It successfully met all the primary and secondary endpoints in all QUANTI studies. The QUANTI programme included two Phase 3 studies, QUANTI CNS for the central nervous system and QUANTI OBR for other body regions in adults.

Upcoming webinars

Terumo: Unleashing the Potential of Intradermal Injection
EliTech Group: CMV RNA test: a new approach to monitoring cytomegalovirus infections in high-risk patients

Recommended webinars

Meridian Bioscience: The Evolution of STI At-Home Testing Solutions
Dupont Liveo: Designing smart wearables for improved performance & comfort
WuxiApptec: Designing Extractable/Leachable Studies for Drugs and Biologics
Loftware Siemens: The challenge of labeling & UDI for medical device
Particle Measuring Systems: Environmental Monitoring Compliance Learning from FDA Warning Letters
Rockwell Automation: A Unified Data Platform Delivers Integrated Pat and CPV
IDAM: Identity and Access Management: A Modern Approach to Securing Your Business

Thanks for reading; we hope you enjoyed it.

Until next week.

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Medical Device Developments Weekly