The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.
Repligen Corp. acquired 908 Devices Inc.’s desktop portfolio of four devices for bioprocessing process analytical technology (PAT) applications for $70 million in cash.
The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.
Astrogen Co Ltd. has disclosed prodrugs of 5-aminolevulinic acid (5-ALA) derivatives acting as fluorescence imaging agents and photosensitizers in photodynamic therapy with improved storage stability, reported to be useful for diagnosis and treatment of cancer, aging, alopecia, insomnia, inflammatory and metabolic disorders.
Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods.
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
Researchers from Weill Cornell University filed for protection of discoveries made from investigations into the mechanisms underlying depression, which revealed that a specific brain network is significantly larger in individuals affected by depression.
The U.S. FDA hasn’t taken up criminal justice as a sideline, but it did just clear Sonio Suspect. Far from a social miscreant, Suspect improves detection of fetal anomalies by 22 points by automatically detecting multiple types of abnormal findings and allows for detection as early as 11 weeks of gestation.
Up to 50% of glaucoma cases have a genetic component, a factor which could significantly change the screening recommendations and monitoring of patients – if they know their risk. Seonix Pty. Ltd. has a vision for making that genetic information easier to obtain and use to guide care with its Sightscore saliva-based test.
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