By Stewart Eisenhart, Emergo Group Changing regulatory environments continue to present the biggest business challenge for a majority of medical device company senior managers, according to an annual Emergo industry survey. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not […]
New material illuminates when exposed to chemicals on the body
MIT engineers and biologists teamed up and designed a living-cell-injected hydrogel that can illuminate when exposed to certain chemicals. The MIT team made wearable sensors using the hydrogel with living cells that lit up after touching a surface with certain chemicals. The new material has the potential to detect chemicals in the environment and the […]
This ingestible sensor is powered by stomach acid
MIT and Brigham and Women’s Hospital researchers have announced an ingestible device innovation: a small voltaic cell that can withstand the acidity of fluids in the stomach and still transmit information to a base station. The small device can stay in the gastrointestinal tract for long periods of time and can produce enough power to […]
South African medical device companies have new licensing deadline
By Stewart Eisenhart, Emergo Group South Africa’s Medicines Control Council (MCC) has set a six-month deadline for domestic medical device and IVD manufacturers and distributors to apply for licensing in order to legally operate in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are […]
MedCrypt and QuiO partner to protect devices from cyberattacks
MedCrypt and QuiO have announced an integration partnership for a set of cloud-connected injection devices known as the Smartinjector devices to provide safe data transfers of patient prescriptions and injections. OuiO will receive software security with this partnership for its Si One, for specialty drugs, and Si Pen, for diabetes patients. MedCrypt’s software will be able to sync […]
Russian deadline for replacing old medical device license extended
By Stewart Eisenhart, Emergo Group The Russian government has pushed back a deadline for replacing medical device registration licenses issued before 2013 to December 2021 in order to harmonize requirements under the Eurasian Economic Union Agreement. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
Medical device companies report sales increases in 2016
By Stewart Eisenhart, Emergo Group One third of all medical device companies participating in a recent Emergo industry survey reported sales increases of 10% or more for 2016. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Genetically engineered T-cells treat leukemia in babies
Researchers in London have successfully treated leukemia in two babies, in what they are touting as the world’s first treatment of cancer using genetically engineered immune cells from donors. Two British infants, who were 11 and 16 months old, were treated using Cellectis’ CAR T-cell product, UCART19, which is an allogeneic CAR T-cell product candidate […]
Chinese regulators modify IVD classification requirements
By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have issued a new order affecting how in vitro diagnostic (IVD) devices are classified according to risk levels. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
Mexico proposes changes to medical device regulations in 2018
By Stewart Eisenhart, Emergo Group Mexican regulators are in the early stages of revising various elements of the country’s sanitary registration process for medical devices, including classification, biocompatibility and technovigilance. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
