In-vitro diagnostics

08

Jun 2023

In the period of April-May 2023, the Galician Agency for Health Technology Assessment (AVALIA-T) initiated the five health technology assessments referred to IVD, nephrology and urology, obstetrics and gynecology, pulmonary and airways as well as surgical procedures technology groups. The assessments on stereotactic virtual navigation system for percutaneous puncture as well as tumor ablation and invasive telemonitoring of pulmonary pressure in patients with heart failure were released. Read more

07

Jun 2023

In May 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries), two new Diagnostic Guidance (MRI fusion biopsy systems for diagnosing prostate cancer, automated ankle-brachial pressure index measurement devices to detect peripheral arterial disease), and three new Health Technology Evaluations (Digitally enabled therapies for adults with anxiety disorders / with depression, and point-of-care tests for urinary tract infections). Also, four clinical guidelines were updated. Read more

19

May 2023

In April and May 2023, it was announced that the Galician Agency for Health Technology Assessment (AVALIA-T) initiated several HTAs, including the evaluations in the e-health, nephrology and urology, men’s health, IVD, obstetrics and gynecology, pulmonary and airways, surgical procedures, and some other fields. Read more

18

May 2023

On April 28, 2023, the NHS Cancer Programme awarded £12.1 million to six innovations that improve the early detection and diagnosis of cancer. Awarded medical devices, in-vitro diagnostics, and digital health solutions are used to diagnose bowel, skin, liver, breast, ovarian, and esophageal cancer. They have proven their efficacy and clinical effectiveness and will be funded over the next 18 months to support rollout and real-world testing. Read more

15

May 2023

In late April, NHS Accelerated Access Collaborative introduced the Health Technology Navigation Pathway Tool to help innovators adopt new technologies into the NHS. The Tool breaks the innovation journey down into 25 steps, themed around the five key phases of the product lifecycle, from creation to commissioning and adoption. For each step, the schematic flowchart outlines key organizations to engage with, regulatory insights, best practice approaches, policies, guidelines, to-do lists, and required outputs. Read more

10

May 2023

In April 2023, the National Institute for Health and Care Excellence (NICE) published seven new Interventional Procedure Guidance (concerned Daytime intraoral neuromuscular electrical tongue stimulation, endoscopic ultrasound-guided biliary drainage, maximal cytoreductive surgery in ovarian cancer, percutaneous thoracic duct embolization, radiofrequency ablation for spinal metastases, high-intensity focused ultrasound for prostate cancer), one new Medical Technologies Guidance (AposHealth for knee osteoarthritis), and one Medtech Innovation Briefing (Fasciotens for abdominal wall closure). Also, three clinical guidelines were updated. Read more

08

May 2023

On April 14, 2023, a repository of innovative acts outside the nomenclature of biology and anatomopathology (RIHN) and a Supplementary list of IVD tests were published. Minor changes were introduced in the 2023 RIHN list. Read more

05

May 2023

On April 19, 2023, the Italian Ministry of Health announced that the State-Regions Conference approved the national tariffs for outpatient specialist care and prosthetic care. These tariffs will be applied to Annexes 4 (outpatient specialist care) and 5 (prosthetic care) of the Essential Levels of Care (LEA) document from 2017. New tariffs for outpatient specialist care will enter into force in January 2024, and the tariffs for prosthetic care will enter into force on April 1, 2024. Read more

21

Apr 2023

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests. Read more

07

Apr 2023

In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published. Read more

22

Mar 2023

A new preeclampsia screening algorithm has been evaluated within the "New Method" framework since 2021. The algorithm helps to predict the risk of preeclampsia in the first trimester based on several parameters, including ultrasound examination and measurement of the Placenta Growth Factor (PIGF). In March 2023, the Decision Forum for "New Method" was held and commissioned to perform the implementation study of a new screening algorithm at St. Olav's Hospital. Read more

20

Mar 2023

On March 1, 2023, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) updated three Articles of the Nomenclature related to in-vitro diagnostics. Twelve new codes concerning clinical biology, molecular biology for infections, and genetics were implemented. Read more