The official compliance date for the European Union’s Medical Device Regulation (MDR) is now officially in force after a delay of two years. One of a number of unfortunate side effects is that the mutual recognition agreement (MRA) between the EU and the Swiss government has lapsed, and the European Commission has indicated that the two sides have not come to terms over the impasse. Read More
In an effort to address the longstanding issues with medical device manufacturers failing to comply with Section 522 postmarket surveillance studies, the FDA is looking to revamp 2016 policies in new draft guidance issued on Wednesday. A separate FDA draft document seeks to update guidance on post-approval study requirements for high-risk devices with new policies on procedures and submissions. Read More
Woebot Labs Inc. got a bit of a pick-me-up with the FDA's decision to grant breakthrough device designation to the company's digital therapeutic for postpartum depression. The WB001 app combines cognitive behavioral therapy with interpersonal psychotherapy and an understanding of how postpartum depression affects interactions and daily life. The investigational treatment is designed as an eight-week, prescription-only intervention for women under a physician’s care. Read More
Digital therapeutics startup Akili Interactive Inc. has secured $160 million in a combined equity and debt financing to accelerate commercialization of its Endeavorrx platform for cognitive disorders. The company won FDA clearance and the CE mark in June 2020 for its video game-based treatment, Endeavorrx ALK-T01, for children with attention deficit hyperactivity disorder (ADHD). Read More
For the next three years, the government of Shanghai will hand out R&D subsidies up to ¥100 million ($15.6 million) per year to each biopharma company in the municipality to support innovative medicines. Med-tech players can also each receive up to ¥15 million a year for developing innovative devices. Read More
LONDON – Ibex Medical Analytics Ltd. has secured a second CE marking for its Galen artificial intelligence decision support system for automated interpretation of tumor biopsies, adding breast cancer to the approval in prostate cancer secured just over a year ago. The CE mark follows results from a blinded, multicenter clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Ibex says that in the trial Galen breast demonstrated very high accuracy in detecting various types of breast cancer. Read More
Med-tech firms raising money in public or private financings, including: Dynamics, Hello Heart, Intocare Medical Technology, Sonnest, Torus Biosystems. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biodesix, Blue Earth Diagnostics, Veracyte. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beyond Air, Circassia Group, Exthera Medical, Gensight Biologics, Henry Schein, Innova Medical Group, Medical Diagnostic Laboratories, Mesi, Mirati Therapeutics, Neovasc, Qiagen, Sharp Packaging, Retractable Technologies, Udg Healthcare. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bimini Health Tech, Ibex, Koya Medical, One Drop, Pentax Medical, Turner Imaging Systems, Varian, Visionairy Health, Xandar Kardian. Read More
