European Commission Designates Fifth Notified Body

January 30, 2020 TÜV Rheinland joins IMQ, BSI Assurance UK, TÜV SÜD Product Service and DEKRA as the only NBs that can certify device makers for MDR compliance. European device groups have expressed concern about a shortage of notified bodies to conduct audits and certify device makers in time to comply with the new regulations … Read more

Cincinnati Children’s Hospital researchers grow mini liver, pancreas and biliary ducts from stem cells

January 28, 2020 Developments with bioengineered miniature organs called organoids are not quite there yet.  However, a multidisciplinary team at the hospital’s Center for Stem Cell & Organoid Medicine (CuSTOM) say they have made a breakthrough discovery that brings them a step closer.  Cincinnati Children’s Hospital’s CuSTOM team — made up of scientists, clinicians, geneticists, … Read more

FDA proposes new market pathway for medical devices touting safety innovations

January 21, 2020 The Agency (the United States Food and Drug Administration – FDA) modeled the voluntary regulatory process after its selective Breakthrough Devices Program; however, with the goal of recognizing and rewarding innovation in areas that might not make the cut.  While the breakthrough program focuses on life-threatening diseases and unmet medical needs, the … Read more

Physicians increasingly too busy to see pharm sales reps

January 16, 2020 Given the common complaint that they do not have enough time to spend with patients, busy doctors are making less time to meet with pharma representatives, according to the annual ePharma physician report from Decision Resources Group, a healthcare research and consulting company. As physicians increasingly struggle to balance their time with … Read more

Many cancer drugs do not hit their intended targets

January 14, 2020 After examining the mechanisms of 10 cancer drugs that were thought to target one of six (6) proteins, Jason Sheltzer and colleagues at CSHL made the unexpected discovery that the drugs may indeed kill tumor cells, but not by blocking their intended targets.  The medicines they scrutinized came from companies that included Celgene … Read more

Apple unveils large-scale research studies tracking activities, hearing and women’s health

January 09, 2020 Conducted in partnership with academic and healthcare institutions, the studies aim to tap nearly any Apple product customer as a potential research participant.  The tech giant’s planed to make its Research app available as a free download in late 2019.  Apple’s previous heart-focused study canvassed more than 400,000 people in the U.S. … Read more

Could gene therapy be the solution to obesity and diabetes?

January 02, 2020 When the researchers inhibited FABP4 in white adipose tissue — commonly known as the unhealthy white fat—they observed a reduction in lipid storage.  Then they tried it in mice that had been fed a high-fat diet, injecting them twice a week with the CRISPR interference system.  The mice lost 20% of their … Read more