The gaps between the new EU legislation on diagnostics and the on-the-ground reality.

The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years - a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to diagnostics (IVDs).

A new multimodal device for atrial fibrillation detection: ECG quality analysis in healthy volunteers.

In the context of increase in cardiovascular diseases in the aging population, including a high prevalence of atrial fibrillation (AF), the development of medical devices to ensure patient follow-up is of major interest. The purpose of this study is to assess the ECG signal quality of a one-lead in a new miniaturized device on healthy volunteers submitted to several conditions reflecting daily life activity. Our results show that the P wave identification is not enough reliable to consider the detection of its potential disappearance in case of AF.

5'-substituted adenosine analogs as new high-affinity partial agonists for the adenosine A1 receptor.

5'-(Alkylthio)-, 5'-(methylseleno)-, and 5'-(alkylamino)-substituted analogues of N6-cyclopen-tyladenosine (CPA) were synthesized in 30-50% overall yields. The affinities of these compounds for the adenosine A1 and A2A receptors were determined in rat brain membranes. The 5'-substituted CPA analogues proved selective for the adenosine A1 receptors, displaying affinities in the nanomolar range.

Synthesis and pharmacological investigation of new chiral muscarinic antagonists.

The two pairs of enantiomers of isoxazolidin-3-ones 3 and 4 were synthesized by means of Lipase PS-catalyzed hydrolyses of suitable racemic butyrates. The same butyrates were also employed as key intermediates in the preparation of racemic 3 and 4. The antimuscarinic potency of the new compounds was assayed in two in vitro functional tests.