Neogenomics Inc. stunned investors, reporting that Mark Mallon would step down as CEO and board member, effectively immediately. Tuesday’s unexpected announcement – coupled with news that first-quarter revenue could miss prior guidance – sent Neogenomics stock (Nasdaq: NEO) down 29.8% to close at $12.49, and triggered a 52-week low of $11.00 earlier in the day. Read More
Vivosense Inc. aims to improve clinical trial recruitment and outcomes by developing new digital biomarkers and clinical outcome assessments (COAs) that use data from wearable devices, a goal made a touch easier by its successful completion of a $25 million series A financing round. The company’s platform is designed to detect and rigorously interpret subtle shifts in physiology using body-worn sensors. Read More
Negotiations between the U.S. FDA and industry over device user fees were a protracted struggle, but the agency was demonstrably loathe to post the minutes from meetings between the agency and industry representatives. Jeff Shuren, director of the FDA’s device center, said in a congressional hearing that those minutes were not posted because of a need to wrap up the negotiations rather than allow outsiders – including members of Congress – to see how difficult the negotiations had become. Read More
Health tech firm Qure.ai Technologies Private Ltd. has secured a $40 million investment from investors including Novo Holdings and Healthquad to expand its portfolio of automated artificial intelligence (AI)-based imaging diagnostics. The company’s suite of technologies incorporates deep learning and AI to interpret radiology images such as X-rays, CTs, and ultrasounds in less than a minute. Read More
Elix Inc. has teamed up with Shionogi & Co. Ltd. to validate a retrosynthetic analysis model for drug discovery that will employ chemical reaction data from Shionogi to explore various routes to synthesizing new molecules. Read More
The U.K. National Institute for Health and Care Excellence said its review of the Prontosan line of wound care products by B. Braun Medical AG of Melsungen, Germany, may be a cost saver for the National Health System compared to saline flush for chronic wounds. However, the agency also noted that most of the evidence of the effectiveness is of “not good quality,” suggesting that the company conduct more clinical trials to cover the evidence gap. Read More
New hires and promotions in the med-tech industry, including: Advanced Ostomy Tools, Contraline, Delfi Diagnostics, Innovheart, M2gen, Tissuevision, Voxneuro. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Masimo, O'Brien, Synchron, University of Portsmouth. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biosig, Caire, Caredx, Curi Bio, Elekta, Hologenix, Keen Eye, Medanex, Medline, Namsa, Quanterix, Stembiosys, Ultivue. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Cartiheal, Life Spine, Nanovibronix, Optellum, Shockwave Medical. Read More
