The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
$5.9 bn
The global reprocessed medical devices market is likely to surpass the value of $5.9 bn by 2028
1 million
More than 1 million children in Africa have received one or more doses of the world’s first malaria vaccine, thanks to a WHO pilot programme
$4.17bn
Philips has reported group sales of $4.17bn (€3.9bn) in Q1 of 2022, compared to €3.8bn posted in the same period a year ago
60%
Almost 60% of the US population has been infected by Covid-19, a new study from the CDC reveals
431
As of 26 April, 431 Covid-19 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs)
Latest news
Commission Seeks To Extend Delegated Act Powers By Five Years Having Not Used Its Powers Yet
The European Commission has issued a report in a move intended to extend its powers to amend the MDR and IVDR in places where the text of the regulations allow this.
Source: Medtech Insight
New FDA Supply Chain Program Aims To Prevent Device Shortages
The US FDA is building a new Resilient Supply Chain Program, which aims to bolster the nation’s supply of essential medical devices and prevent future shortages. The new program will be the focus of the agency’s June workshop
Source: Medtech Insight
BioInteractions launches new medical device coating technology
BioInteractions, a UK biomaterial technology company, has launched TridAnt, a new coating technology for medical devices which represents a paradigm shift in infection prevention and protection against a broad range of pathogens.
Source: Med-Tech News
Clinical trials
MicroVention begins subject enrolment in balloon guide catheter trial
Terumo’s wholly-owned subsidiary MicroVention has announced the enrolment of the first participant in the STRAIT study of its new BOBBY balloon guide catheter.
A multi-centre, prospective observational study, STRAIT is being conducted in the European Union (EU).
It has been designed to assess the BOBBY balloon guide catheter’s safety and performance for endovascular treatment of acute ischemic stroke.
Source: Medical Device Network
Novavax begins Phase III trial of Covid-19 vaccine booster in adolescents
Novavax has commenced administering the initial booster doses of its protein-based Covid-19 vaccine, NVX-CoV2373, in the paediatric expansion of the Phase III PREVENT-19 clinical trial.
The trial will assess the safety and immunogenicity of a third dose of the vaccine in adolescent trial subjects aged 12 to 17 years. The company anticipates reporting preliminary data from the trial during the second half of this year.
All the subjects in PREVENT-19 of this age group are now eligible to receive a third booster dose of the vaccine.
Source: Clinical Trials Arena
Eiger reports positive data from Phase II congenital hyperinsulinism trial
Eiger BioPharmaceuticals has reported positive findings from a Phase II trial where its investigational therapy avexitide showed to substantially lower the chances of fasting and protein-induced hypoglycemia in children with congenital hyperinsulinism (HI).
A glucagon-like peptide-1 receptor (GLP-1r) antagonist, avexitide is being developed to treat congenital HI and post-bariatric hypoglycemia (PBH).
Conducted at Children’s Hospital of Philadelphia, US, the investigator-sponsored, open-label, crossover trial analysed the effects of avexitide versus a saline control on fasting- and protein-induced hypoglycemia in children with HI.
Source: Clinical Trials Arena
Nines
US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.
Source: Nines
Lucira Health
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
Bloomlife
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.
Source: Bloomlife
