Europe’s Promising (But Rocky) Path to Embracing Single-Use Device Reprocessing
A proposed amendment to existing legislation could create centralized and harmonized rules for single-use device reprocessing across all EU member countries.
A proposed amendment to existing legislation could create centralized and harmonized rules for single-use device reprocessing across all EU member countries.
In today's dynamic environment, companies are navigating deal-making and innovation spurred by the vertical integration of AI and a rebounding IPO market. Here are ten global trends poised to define the industry in the coming year.
MedCity News was at the Vive conference and spoke with executives who shared their insights for the healthcare industry.
BioInnovation Institute, which has supported 131 startups in Denmark to date, will use the new funding to expand its reach to startups across Europe. This innovation engine spun out of the Novo Nordisk Foundation in 2020.
Xofluza, a flu antiviral drug developed by Roche and Shionogi, is now approved in Europe for children age 1 and older. The European Commission decision expands the patient population for the drug, which was previously approved for treating adolescents and adults.
Nephrology products company Vifor Pharma is shelling out about $252 million combined up front to acquire Sanifit Therapeutics and Inositec, developers of drugs for a blood vessel complication affecting some chronic kidney disease patients. Both biotechs are in clinical trials with their respective lead drug candidates.
Epic led global, non-U.S. EMR purchasing in 2020, a year that saw strong activity in the arena despite the pandemic. But certain regions did experience a downswing, including Latin America, where Brazil saw a 50% drop in EMR purchasing.
In Europe, three major categories of care currently being aided by digital tools: distance diagnoses, internal communications, and external collaborations.
Which EHR vendors were the hottest across the globe? The KLAS "Global EMR Market Share 2017" report analyzes new hospital EHR contracts that happened all over the world in 2016.
More big news for Dexcom. Its G5 continuous glucose monitor will soon be available for use in several European countries.
Serious U.S. regulatory lags are driving the medical device business to Europe – with startups, clinical trial sites and market approvals all migrating eastward at a rapid clip. At the same time, the Food and Drug Administration has stated it has the vision for the U.S. to be the world’s leader in medical device innovation and manufacture. […]
Small practices play a critical role in healthcare delivery, but they cannot continue to absorb ever-increasing administrative demands without consequences.
LONDON (Reuters) – European drugs regulators gave their backing on Friday for marketing approval to be granted for Bayer’s drug Adempas, designed to treat pulmonary hypertension, and for GlaxoSmithKline’s diabetes medicine Eperzan. The regulator also backed a new drug from Dainippon Sumitomo Pharma called Latuda, for the treatment of schizophrenia, and Bemfola, a new biosimilar […]
(Reuters) - PTC Therapeutics Inc said a committee of the European Medicines Agency did not recommend conditional approval of its drug for the treatment of a rare muscular disorder, sending its shares down as much as 28 percent in premarket trading. The...
ZURICH (Reuters) – Novartis said it would ask the European health regulator to look at its heart failure drug serelaxin again after the body took an unfavorable position on it Friday. “Novartis announced today it will shortly submit a revised filing package, including new data analyses, for re-examination for conditional approval of RLX030, or serelaxin,” […]
Boston Scientific (BSX) announced it has received the CE Mark for its Vercise Deep Brain Stimulation System for the treatment of dystonia, “a neurological movement disorder characterized by involuntary muscle contractions.” Dystonia is the third most common movement disorder after Parkinson’s disease and essential tremor, and more than 500,000 patients in Europe have it, according […]
The healthcare startups in the race to launch an approved noninvasive, bloodless glucose meter for the growing diabetes patient population is on. While each company etches out its value proposition and aims for commercial launch, a look at what the devices with potential for success in this space have in common. What the successful breakout […]