Swiss company Vifor Pharma and Germany’s Evotec AG launched a joint venture to focus on the discovery and development of new therapies for kidney diseases. Vifor picks up external R&D capabilities for its own nephrology pipeline and Evotec gains a…
Europe allows Edwards’ Sapien 3 TAVR system in low-risk patients
Dive Brief: Edwards Lifesciences’ Sapien 3 transcatheter heart valve is now allowed for use in Europe in patients at low risk for complications in open heart surgery, the medtech said Wednesday. The CE mark expanding the indication for the Edwards…
Epidermal Display Screens for On-Body Flexible Medical Devices
Researchers from Nanjing University in China have developed a way to place displays on human skin that are flexible, safe, and don’t require a lot of power to run. The technology will certainly have implications for the field of wearable…
Bioplus Life Sciences and Global Regulatory & Consumer Insights sign Strategic partnership Agreement
Global Regulatory & Consumer Insights (GR-CIS) a leading Regulatory service provider announced that it has been selected as the strategic partner by Bioplus Life Sciences, a global biopharmaceutical company, to provide clinical development and regulatory services worldwide. GR-CIS will work…
Phillips-Medisize to manufacture drug and device combination wearable
The product is stated to be in post-phase three development-stage and combines two-day, single use, disposable technology for subcutaneous drug delivery. The wearable needs to be replaced every two days and can be worn using an adhesive patch or near…
Medtech player to commercialise device for mental health illnesses
Australian medtech company NeuralDx is set to progress the commercialisation of its EVestG device, which supports clinical diagnosis of psychiatric and neurological disorders. The EVestG device enables clinicians to diagnose such disorders via digital biomarkers – a quick, painless, convenient…
Fresenius gets breakthrough tag for clot-preventing dialysis device
Dive Brief: Fresenius Medical Care received FDA’s breakthrough device designation for a new hemodialysis system, the company said Thursday. The system features a polymer called Endexo designed to cut the risk of clotting, thereby reducing the need for physicians to…
Medtronic developing fully implanted LVAD with FDA breakthrough support
Dive Brief: Medtronic received FDA’s breakthrough device designation for a new implantable heart pump it is developing to treat patients with advanced heart failure, the company announced Tuesday. The left ventricular assist device (LVAD) in development would be fully implanted without…
FDA puts J&J’s Ethicon surgical stapler recall in top risk category
Dive Brief: FDA has categorized Johnson & Johnson unit Ethicon’s recall of its Echelon Flex Endopath staplers as a Class I event, the agency saidWednesday. The agency put the recall of 8,256 devices in its highest-risk category after concluding the fault…
The Roivant-Sumitomo Deal: $3 Billion, 5 Companies, $550 Million in Loans and an Option on 6 More Companies
In September, Roivant Sciences, Vivek Ramaswamy’s umbrella biotech company, agreed to sell ownership of five of its Vant companies to Japan’s Sumitomo Dainippon Pharma for $3 billion. Sumitomo Dainippon also was buying an equity stake of more than 10% of…
