The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
780
As of 2 June, 780 laboratory-confirmed cases of monkeypox have been notified to WHO in 27 non-endemic countries in four WHO Regions
438
As of 7 June, 438 Covid-19 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs)
11m
UK medical aid donations to Ukraine to reach 11 million items
30
EU now has 30 notified bodies designated under the Medical Device Regulation (MDR)
$6.5m
3D printing medical devices market is projected to reach $6.5 billion by 2028 from $2.1 billion in 2021
Latest news
Illumina sequencing devices vulnerable to critical hacking risks, FDA warns
Illumina has discovered multiple cybersecurity flaws in software embedded in several of its genetic sequencing instruments, potentially opening a door for hackers to access or alter patients’ sensitive health data, the FDA warned in a June 2 notice to healthcare providers.
Source: Fierce Biotech
A test bed to support innovation in high-risk medical devices
The EU-funded TBMED (A testing bed for the development of high-risk medical devices) project has been tasked with creating and implementing an Open Innovation Test Bed to support SMEs that specialise in the development of high-risk medical devices such as heart valves and hip replacements.
Source: CORDIS
Perfusion Machine Restores Donor Liver for Transplant
Clinical researchers at the University of Zurich in Switzerland have created a perfusion machine to store donor livers before transplant. The team has also announced that they stored and treated a damaged liver in the machine, which would ordinarily not be suitable for transplantation.
Source: MedGadget
Clinical trials
Insulet reports positive data from Omnipod 5 insulin delivery system trial
Insulet has reported positive data from its pivotal extension trial of the Omnipod 5 Automated Insulin Delivery System conducted in children aged two to 5.9 years with type 1 diabetes.
The trial data demonstrated that the new system significantly improved glycemic outcomes in children of this age group with type 1 diabetes after more than 12 months of use.
Omnipod 5 is claimed to be the first wearable, tubeless automated insulin delivery (AID) system in the US.
Source: Medical Device Network
Grail, AstraZeneca partner to develop companion diagnostic tests
Grail and AstraZeneca have entered into a strategic collaboration for the development and commercialisation of companion diagnostic (CDx) assays for the latter’s therapies.
Initially, the companies will focus on developing CDx tests for identifying high-risk, early-stage cancer patients.
The collaboration also includes plans for many studies across multiple indications over the next several years.
Additionally, they intend to use Grail’s methylation platform to identify and recruit patients with early-stage disease across multiple tumour types for AstraZeneca’s clinical studies.
Source: Medical Device Network
Filterlex Medical reports positive data from CAPTIS device study
Cardiovascular medical device startup Filterlex Medical has reported positive data from its CAPTIS full-body embolic protection device in a first-in-human (FIH) study.
The next-generation CAPTIS device is designed to lower the risk of stroke as well as other problems during left-heart procedures. It can be deployed and retrieved easily and intuitively.
With a distinctive, triple-action design, the device deflects, captures and removes embolic particles while providing full-body embolic protection.
Source: Medical Device Network
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
