In-vitro diagnostics

20

May 2022

In April 2022, NHS England and NHS Improvement (NHSEI) announced that the timelines for the evaluation of applications to update the National Genomic Test Directory in 2022/23 are currently under review. Previously, NHSEI planned to publish and implement the 2022/23 Test Directory by April 2022. While the timelines are not confirmed, applications can still be submitted. Read more

17

May 2022

On April 21, 2022, NHS England and NHS Improvement updated the 2021/22 National Genomic Test Directory (version 3), which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Forty-two new codes (test-indication combinations) were introduced in the cancer field, and fourteen for rare and inherited diseases. Read more

13

May 2022

In April 2022, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 0183 and 0080 with changes to be implemented no later than June 14, 2022. Eleven new procedure codes and nine new diagnostic codes were introduced. Read more

10

May 2022

A new test called Genedrive System to detect babies at risk of gentamycin-related deafness was developed at the University of Manchester, funded by the National Institute for Health and Care Research (NIHR). On April 02, 2022, NHS England and NHS Improvement announced that Genedrive is now fully CE certified to be used in a clinical setting. The test is expected to be implemented in routine care in all NHS Manchester Foundation Trust hospitals within several weeks. Read more

28

Apr 2022

In March 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (endoscopic balloon dilation for subglottic or tracheal stenosis, intramedullary distraction for lower limb lengthening, endoscopic full thickness removal of gastrointestinal stromal tumors of the stomach, percutaneous insertion of a cystic duct stent after cholecystostomy, and liposuction for chronic lipoedema), four new Medical Technologies Guidance (myCOPD, UroShield, Prontosan for wounds, and 3C Patch for diabetic foot ulcers), one new Diagnostic Guidance (terminated assessment of Freelite assays for multiple myeloma), and six new Medtech Innovation Briefings (Genedrive MT-RNR1 ID System, icobrain for multiple sclerosis, Al for analyzing chest X-ray images, and others). Also, three new clinical guidelines were published, and six were updated. Read more

22

Apr 2022

On March 10, 2022, santésuisse announced that the Swiss Federal Department of Home Affairs (FDHA) had decided to reduce the tariffs for laboratory tests, which is a consequence of santésuisse's repeated call for price reductions in the previous years. Santésuisse expects the price reduction to be substantial and to enter into force soon. Read more

19

Apr 2022

In February 2022, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned biomarkers for assessing acute kidney injury, non-invasive testing for neovascular macular degeneration, decision support tool to prevent falls in older people, endometrial scratch, distal radius fracture, and test for group B Streptococcus. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance. Read more

05

Apr 2022

In February 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (stereotactic radiosurgery for trigeminal neuralgia, and microwave ablation for primary or metastatic cancer in the lung), two new Diagnostic Guidance (EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules, PredictSURE IBD and IBDX to guide treatment of Crohn's disease), and four new Medtech Innovation Briefings (Insides System for managing intestinal failure, d-Nav insulin management app for type 2 diabetes, GaitSmart for personalized exercise rehabilitation, AposHealth for knee osteoarthritis) Read more

28

Mar 2022

In March 2022, NHS England and NHS Improvement published the MedTech Funding Mandate (MTFM) policy for 2022/23, which will come into force on April 01, 2022. The MTFM launched in 2021 to support NICE-approved and cost-saving devices, diagnostics, and digital products. Commissioners must fund technologies included in MTFM. Read more

23

Mar 2022

In late January 2022, Swedish Medical Technologies Product (MTP) Council issued an updated version of recommendations regarding gene expression analysis for decision-making on the adjuvant breast cancer treatment, initially published in November 2021. The recommendation to the regions remains the same. The changes were only concerned with the clarification of some facts. Read more

18

Mar 2022

On February 22, 2022, 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 2022 RIHN list. Read more

17

Mar 2022

On February 21, 2022, it was announced by the Ministry of Health that the public consultation regarding the Draft Order amending the Common Package of Benefits of the National Health System (SNS) was open. The amendments and clarifications are related to the fields of in-vitro diagnostics, ENT, pulmonary and airways, e-health, neurology, dental care, radiology, and enteral nutrition. Read more