New software group at European Commission:
This article was originally published in Clinica
The European Commission's Medical Devices Experts Group has set up a new working group on medical device software. The group will focus on issues including: risk management guidance for medical software; guidance for notified bodies involved in software assessment; the quality of European medical software standards; software design; the quality of European medical software standards; quality assurance throughout the software life cycle; including updates; design validation within conformity assessment procedures for medical devices; and validation of commercial, off-the-shelf software for medical appliances.
You may also be interested in...
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.