PARIS – Neos Surgery SL has been awarded funding under the leading European program for innovative SMEs, the EIC accelerator. (previously known as SME Instrument). This Spanish med-tech company was one of just 38 projects selected from among 4,200 applicants from 18 countries across Europe. Neos has been awarded a non-repayable grant of $2.3 million towards developing its groundbreaking Disc Care device, used in the treatment of herniated disc.
The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO shoots down Draeger appeal of VA bid; Three EU nations join stockpile program.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants EUA to Quanterix for Simoa test; EC investing in startups; Alternatives to animal testing a challenge; USPTO seeks more uniformity between PTAB, courts; NICE nods to Olympus Plasma for BPH.
As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
PARIS – At the recent annual HealthTech Innovations Days in Paris, the European investment Fund (EIF) and the world’s largest life sciences consortium, EIT Health Germany, reported the development of a Venture Centre of Excellence (VCoE) in Europe.
LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.
LONDON – EU health ministers have given the go-ahead for the European Commission to negotiate COVID-19 vaccines contracts on behalf of all 27 member states, approving the use of a €2.3 billion (US$2.6 billion) emergency fund for down payments.
LONDON – The European Commission is laying plans for joint procurement of COVID-19 vaccines on behalf of all 27 EU member states, and is in discussions to agree on a harmonized approach to access and who gets vaccinated first.