The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
421
As of 15 February, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs), according to the FDA.
291
These include 291 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests.
20%
Qiagen has reported a 20% increase in full-year 2021 net sales, with high demand for Covid-19 test products and positive trends in the non-Covid portfolio contributing to the rise in sales.
67%
In 2020, Fisher & Paykel Healthcare, a medical devices firm, made a SBTi commitment to reduce GHG emissions by 67% by 2034, according to research by GlobalData.
$1 trillion
IoT will be a $1 trillion industry by 2024, thanks to rapid growth in the number of connected devices across enterprise and consumer markets, according to GlobalData analysis.
Latest news
Rapid Medical obtains FDA breakthrough device designation for Comaneci
Advanced neurovascular devices developer Rapid Medical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Comaneci embolisation assist device. Comaneci is designed to enable treatment of cerebral vasospasm after hemorrhagic stroke.
Source: Medical Device Network
OxDX raises funding for rapid diagnostic technology development
Oxford University spin-out company OxDX has raised £2.6m in pre-seed funding for the development of artificial intelligence (AI)-powered rapid diagnostic technology. The company’s rapid diagnostic technology can detect and recognise specific species and strains of bacteria, viruses and other pathogens in a sample.
Source: Medical Device Network
TytoCare Receives CE Mark Approval for its Lung Sounds Analyzer Providing Clinicians with AI-Powered Decision Support During Remote Examinations
TytoCare announced today that it received CE Mark approval for its AI-backed Tyto Lung Sounds Analyzer. The Tyto Lung Sounds Analyzer is a web-based software module that adds additional capabilities to the existing TytoCare solution, designed to aid in the clinical assessment of lung auscultation sound data.
Source: PR newswire
Chinese regulator approves Qiagen’s QFT-Plus test for TB diagnosis
The National Medical Products Administration (NMPA) in China has approved Qiagen’s QuantiFERON-TB Gold Plus (QFT-Plus) test for the detection of tuberculosis infection.
Source: Medical Device Network
Clinical trials
Elixir Medical Completes Enrollment in BIOADAPTOR Randomized Controlled Trial of DynamX Coronary Bioadaptor System
Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced completion of enrollment in the BIOADAPTOR randomized controlled trial (RCT). The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology, allowing for the restoration of normal vessel functions essential to cardiovascular performance.
Source: Business Wire
Mainz Biomed to assess mRNA biomarkers integration into cancer test
Mainz Biomed has initiated the ColoFuture clinical study to assess the integration of a new mRNA biomarkers portfolio into its ColoAlert test for colorectal cancer (CRC). ColoAlert is a non-invasive test designed to detect tumour DNA and CRC cases in the earliest stages from stool samples.
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
