Henlius and OncoHost partner to predict trial outcomes using machine learning
This PROphet platform will analyse the patients’ biomarkers in the serplulimab’s Phase III trial (NCT05468489) to identify resistance patterns in the recruited patient population. Image Credit: aurielaki / Shutterstock. Hengenix Biotech (Henlius USA) has partnered with OnncoHost to perform biomarker analysis and predict clinical benefit probability in the patients recruited as part of the Phase […]
3EO Health receives EUA from US FDA for SARS-CoV-2 test
3EO’s technology offers a preparation-free ‘sample to test’ workflow that helps eliminate the need for expensive equipment. Credit: 3EO Health/Business Wire. 3EO Health has received an Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 molecular test. Its patented biochemistry facilitates a preparation-free ‘sample to test’ workflow, thereby helping […]
Ovum Health partners with IBM Watsonx for fertility care digital service
FertilityAnswer Bot bot includes 150 questions and answers from Ovum Health’s content library of 18,000 user-generated questions. Credit: everything possible/Shutterstock Fertility solutions provider Ovum Health has joined forces with IBM Watson to enhance appointment management and access to patient information. Alice Crisci, a healthcare activist, cancer survivor, mother, and founder of MedAnswers and its telemedicine spinout, Ovum […]
FDA rule change sees Laboratory Developed Tests regulated as medical devices
The FDA has said that since the Medical Device Amendments of 1976 ruling was passed, the field of Laboratory Developed Tests has changed drastically. Credit: Shutterstock / Postmodern Studio Laboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration. The proposed rule […]
China’s mass surveillance may be key to growth in medical device sector
China has a strong medical devices sector, but it is mostly focused on low-complexity goods. Photo: Costfoto/NurPhoto via Getty Images. China, known for its intense surveillance of citizens, may be able to leverage the data it collects to advance its medical devices industry, a new GlobalData report reveals. China’s medical device market is already large, […]
Zeiss, Boehringer to develop predictive analytics for eye diseases
Predictive analytics will help facilitate early detection of eye diseases. Credit: Dmitry Kalinovsky/Shutterstock.com. Zeiss Medical Technology has entered a long-term strategic collaboration with Boehringer Ingelheim for the development of predictive analytics for eye diseases. Predictive analytics will help facilitate early detection of eye diseases and offer more personalised treatments to avoid vision loss for serious […]
Anumana’s ECG-AI LEF device receives clearance to detect LEF
The device helps detect low ejection fraction in patients with heart failure risk. Credit: Fangstw/ Shutterstock.com. Anumana has received US Food and Drug Administration (FDA) 510(k) clearance for its artificial intelligence (AI)-powered medical device, ECG-AI LEF, for the detection of low ejection fraction (LEF). LEF is an asymptomatic and generally undiagnosed heart failure indicator and […]
Medical Device Network Excellence Awards 2023: HemoSonics
HemoSonics is a medical device technology company that provides solutions for point-of-care viscoelastic hemostasis testing through its Quantra® System. The company is a category award winner for Business Expansion and Product Launches in the 2023 Medical Device Network Excellence Awards, as it hit further milestones in the development of its testing solutions, specifically obtaining FDA […]
FDA approves Empaveli injector for PNH patients
The enFuse technology allows drug delivery of up to 25ml. Credit: Castleski via www.shutterstock.com. The US Food and Drug Administration (FDA) has approved Apellis Pharmaceuticals’ Empaveli injector (Enfuse) for the subcutaneous delivery of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare disease that is characterised by red blood cells breaking […]
Cordis completes takeover of MedAlliance in deal rising to $1.1bn
The cardiovascular device market is predicted to be worth $82bn by 2030. Image credit: Shutterstock/mamewmy. Nearly one year on from announcing it had agreed to acquire drug-eluting balloon company MedAlliance, Cordis has completed the takeover in a deal that could surpass $1bn, depending on the attainment of certain milestones. Cordis, who has a range of […]