Lumicks BV raised $93 million in a series D financing led by new investors Farallon Capital Management and Lauxera Capital Partners. The proceeds are earmarked for expansion of the Lumicks’ product pipeline and for commercialization of its Z-Movi cell avidity analyzer. Read More
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients. Read More
The FDA has finalized a 2018 draft rule that excludes several digital products from the definition of a medical device, a list that includes medical device data systems (MDDS) used in hospitals. The rule responds to requirements spelled out in the 21st Century Cures Act, which was signed into law in late 2016, making this a project of nearly five years’ duration on the FDA’s part. Read More
Koelis SAS reported the first successful procedures for its platform in 3D fusion imaging-guided focal ablation of prostate cancer at the Clinique Nantes Atlantis in Saint-Herblain, France. These first procedures take place against the background of a multicenter prospective clinical trial starting on the Koelis platform. This includes eight European urology centers, of which six are in France, with data being stored in a dedicated registry. Read More
Organoids cultured from patient-derived colorectal cancer cells have been used to demonstrate for the first time that tumors which have developed resistance to the full range of existing treatments, across chemotherapies, targeted therapies and immunotherapies, retain a requirement for Werner helicase (WRN) for survival. WRN has a key role in the maintenance of genome stability, but although loss of WRN is known to initiate synthetic lethality in DNA mismatch repair deficient colorectal cancer, studies into the effect of inhibiting that helicase have to date been limited to a handful of cell lines. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angle, Kärcher, Lidds, Neovasc, R-Zero, Stella Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qorvo, Seigla. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT. Read More
Keeping you up to date on recent developments in neurology, including: How tangled proteins kill brain cells, promote Alzheimer’s; Studies evaluate use of telemedicine with Cala Trio; Autism develops differently in girls than boys, new research suggests. Read More
