MedTech Spectrum

Article Name Predictive Diagnostics

2025 Biological Device Application Approvals. How FDA Clearances Are Reshaping Blood Banking, Diagnostics, and Point of Care Medicine

From blood bank software and immunohematology analysers, to HIV diagnostics and platelet rich plasma systems, the 2025 approval landscape signals a clear shift towards automation, safety, traceability, and point of care innovation across transfusion and laboratory medicine

26th December, 2025

Abbott's Volt Pulsed Field Ablation System Receives FDA Approval to Treat Patients with Atrial Fibrillation

Abbott's Volt PFA System is an all-in-one product that is clinically proven to simplify the treatment of AFib that is gentler on the heart, has shorter procedure times and supports better recovery and long-term results

23rd December, 2025

Hardy Diagnostics Partners with NEMIS Technologies to Bring Rapid On-Site Pathogen Detection

The partnership marks a significant step forward in promoting proactive food safety and environmental monitoring

22nd December, 2025

Peer-Reviewed Studies Validate Linus Health AI as an Early Digital Biomarker for Alzheimer's Pathology

Findings show Linus Health's AI can indicate Alzheimer's pathology before noticeable symptoms—enabling earlier action to help protect independence and preserve what makes us who we are

22nd December, 2025

Nyxoah’s Stepwise Approach to Expanding OSA Treatment in Europe

Nyxoah is advancing a differentiated approach to sleep apnea treatment through its Genio system, a bilateral, externally powered hypoglossal nerve stimulation therapy designed specifically for patients who are unable to tolerate CPAP

19th December, 2025

ALZpath and Siemens Healthineers Sign Licensing Agreement to Advance Global Access to Blood-Based Alzheimer’s Disease Diagnostic Testing

Siemens Healthineers will utilise ALZpath’s high-performing, proprietary pTau217 antibody in its growing test menu for its Atellica analysers to enable IVD testing for Alzheimer’s disease

16th December, 2025

Breastfeeding Guidance and Nutrition Support Every New Mother Should Know

Breast milk remains the gold standard for infant nutrition because it naturally adjusts to match a baby’s developmental needs

15th December, 2025

AI Model Offers Breakthrough Path for Early Diagnosis and Novel Cancer Targets

Dr Cifuentes Bernal explains how his AI-powered framework uncovers hidden cancer-associated genes

12th December, 2025

China Gold Irradiation Introduces IBA’s sustainable X-ray irradiation technology

The Jianxing centre in East China will be the first CGI centre to install X-ray technology

11th December, 2025

Seegene Establishes French Subsidiary to Expand European Footprint

France becomes Seegene's eighth overseas sales subsidiary and third in Europe, following Italy and Germany

08th December, 2025

PDS Health Expands SOTA Cloud Partnership with Strategic Investment

Imaging platform to be implemented across more than 1,000 PDS Health dental practices

05th December, 2025

New Biosensors Advance Personalized Cancer Care

Nanocrine's findings will be published at the American Society for Cell Biology annual conference

05th December, 2025

Philips expands commercial availability real-time AI-enabled light-based 3D navigation solution for image-guided therapy

Real-time AI-enabled 3D device visualisation powered by light instead of X-ray, improving navigation in complex endovascular procedures

02nd December, 2025

Advanced CEM tracking enables more comprehensive breast cancer detection

CEM combines standard digital mammography with intravenous contrast to highlight areas of increased blood flow often associated with tumours

01st December, 2025

Avandra Acquires DatCard Systems and Sorna Corporation to Create Largest Medical Imaging Platform

Avandra expands leading medical imaging platform through dual acquisitions, combining clinical data sharing with research innovation

01st December, 2025

Philips launches next-generation web-based diagnostic viewer for fast, secure imaging data access

New viewer offers full radiology capabilities, interfaces with AI and interactive reporting module to streamline workflows

25th November, 2025

Polarean Imaging Signs Distribution Deal with DK Healthcare in South Korea

The Company will collaborate with DK Healthcare to obtain the necessary regulatory clearances ahead of commercial launch in South Korea

25th November, 2025

Siemens Healthineers Introduces AI Enabled Radiology Services to Transform Imaging Workflows

New radiology services suite designed to span scheduling to image acquisition to reporting Custom-built AI services find and summarize clinically relevant observations ActExcell Operational Twin to simulate complex scenarios and recommend improvements to operations in hospital departments Siemens Healthineers is launching artificial intelligence (AI)-enabled services to help healthcare providers address a range of challenges, from hands-on image interpretation to complex scenario planning for entire healthcare environments. The company’s new radiology services suite1 is designed to span the imaging chain from scheduling to image generation to reporting. It bundles existing services and new ones like the AI-Enablement Services that can provide radiologists with custom-built summaries of clinically relevant observations, saving time in annotation of images and creation of reports. In addition, the company is enhancing its advisory services with AI to simulate complex scenarios and recommend improvements to operations in hospital departments and other healthcare providers.2 The new offerings will be presented later this month at the 2025 Radiological Society of North America (RSNA) meeting in Chicago. With increasing demand for diagnostic imaging and a shortage of specialists, pressure on existing staff is growing, and patients are having to wait longer for appointments and results. To reduce the burden on radiology teams while helping them work more efficiently, the new, vendor-neutral services suite is designed to comprehensively support radiologists by taking over some of the more mundane processes. In this way, it can help mitigate the effects of staff shortages and reduce radiologist burnout. Pilot projects have shown that by using the new AI-enabled solution, radiologists were able to annotate chest CT images up to 25 percent faster and experienced noticeably less cognitive load.3 The clinical accuracy of the results remained at the same high level.4 “It is very similar to having a resident physician drafting cases to you, with the tedious work already completed when you open a case. This allows you to move more efficiently through cases and decreases cognitive load,” said William Baughman, MD, radiologist at The MetroHealth System, a nonprofit, public health system in Cleveland, who has already tested the AI offering with his team. The new AI-Enablement Services are an important component of the Siemens Healthineers radiology services suite, which also includes existing services for remote scanning and reading. Customers can thus obtain support from medical-technical radiologists during image acquisition with magnetic resonance imaging through Remote Scanning Services. If customers need support for the generation of the final report, they can also leverage external expertise through Remote Reading Services, carried out by licensed radiologists from external partner organizations of Siemens Healthineers. In this way, radiology departments can better address staff shortages and organize shifts more flexibly while maintaining standards of care for patients. Siemens Healthineers is already working on complementary Load Balancing and Scheduling Services to match patients and staff with the right scanner at the right time, driving more efficient workflows. “Together with our clinical partners, we have identified those steps in the radiological process where we as Siemens Healthineers can effectively relieve some burden by automating or outsourcing routine activities,” said João Seabra, Head of Enterprise Services at Siemens Healthineers. “We look forward to supporting radiology teams with this services suite so that they can focus on providing the best possible care for their patients.” Artificial Intelligence Complements Advisory Services In addition to introducing the new radiology services, Siemens Healthineers is expanding its advisory offering to include the use of AI. ActExcell Operational Twin combines predictive simulation with expert guidance to help customers improve operational performance. Based on customer-specific data, the company’s in-house supercomputer simulates future scenarios, and uncovers the most effective improvements and the path to getting there. These questions are far from simple to answer when one considers the complex interplay of staff planning, facility design, layout and patient scheduling, to name just a few factors. The AI agents are designed to achieve specific targets such as reducing patient waiting times or the time that patients need to spend in scanning rooms. Through ActExcell Operational Twin, the company’s advisors can thus suggest data-informed improvements, explain why certain strategies are preferable, and provide a robust simulation environment before measures are adopted in real-world settings. 1 The Siemens Healthineers Radiology Services mentioned herein are not commercially available in all countries. Remote Reading is currently not available in the United States. Scheduling and Load Balancing Service are still under development. Their future availability cannot be guaranteed. 2 ActExcell Operational Twin is not commercially available in all countries. If the services are not marketed in countries due to regulatory or other reasons, the service offering cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details. 3 The radiologists’ perceived cognitive load decreased by at least 16 percent in pilot studies. 4 The statements by customers of Siemens Healthineers described herein are based on results that were achieved in the customer's unique setting. Because there is no “typical” hospital or laboratory and many variables exist (e.g., hospital size, samples mix, case mix, level of IT and/or automation adoption) there can be no guarantee that other customers will achieve the same results.

25th November, 2025