Castle Biosciences Inc. deepened the moat around its position in melanoma diagnostics with the acquisition of Myriad Mypath LLC from Myriad Genetics Inc. The acquisition gives Castle (NASDAQ:CSTL) the Myriad Mypath Laboratory in Salt Lake City where the Mypath Melanoma 23-gene expression profile (GEP) test is owned and offered. Mypath Melanoma joins Castle's Decisiondx Diffdx-Melanoma, enabling Castle to provide comprehensive molecular testing for difficult-to-diagnose melanocytic lesions.

The FDA has granted breakthrough device designation to Fractyl Laboratories Inc. for Revita DMR, a duodenal mucosal resurfacing treatment for patients with type 2 diabetes. The company recently launched the pivotal REVITA-T2Di clinical trial to evaluate the treatment in this population, in hopes it will offer a new option for people with the metabolic disease.

The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.

TORONTO – Breath analytics technology developed by Picomole Inc. and University of New Brunswick (UNB) researchers promises to identify lung cancer long before it reaches the most advanced stages of the disease. Machine learning sits at the heart of the system, evaluating raw spectral data from a patient’s breath for early diagnosis of lung cancer, Steve Graham, CEO of Moncton, New Brunswick-based Picomole, told BioWorld.

PARIS – One month before the Medical Device Regulation (MDR) comes into force in the EU, the European Association of Notified Bodies (Team-NB) has released the results of its latest annual survey. This survey of CE-marked medical devices compiled data from 26 notified bodies who were members of Team-NB at the end of 2020. According to Team-NB’s 2020 survey, a total of 18,784 valid CE certificates had been issued by last year, representing an increase of 35% over 2010.