Cybersecurity remains a pressing issue for medical technology, in part because there are new, small companies jumping into this space seemingly every day. However, there is a shortage of talent in cybersecurity, something that Dan Lyon, director of cybersecurity at Boston Scientific Corp., of Marlborough, Mass., said will not ease soon due to a lack of interest among colleges and universities in providing curriculum and degrees in this area.
With cancer treatment success rates rising, the field of precision oncology is poised to grow as clinicians aim to move treatment from a one size fits all approach to personalized treatment regimens. Israeli startups including Oncohost Ltd., Nucleai Ltd. and Gina Life Diagnostics Ltd. are part of an emerging wave of companies utilizing artificial intelligence (AI) and machine learning (ML) techniques to personalize the future of cancer diagnostics.
The U.S. FDA’s pre-certification (pre-cert) program for software as a medical device (SaMD) seemed to run out of steam before the COVID-19 pandemic arrived, but the FDA was always presumed to need help from Congress to roll out a permanent version. A session at this year’s MedCon suggests that there is still life left in the pilot version of the SaMD pre-cert program, a critical development given that the legislation for the device user fee program offers the FDA no new statutory authority for a novel software regulatory framework.
Blackrock Neurotech LLC has acquired spatial computing software startup Mindx Corp. to advance full-stack brain-computer interface (BCI) products. As part of the transaction, Mindx’s augmented reality (AR) and artificial intelligence (AI) technology will be integrated with Blackrock’s BCI hardware.
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.
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.
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.
Roche Diagnostics International Ltd. is joining forces with Bristol Myers Squibb Co. (BMS) to develop two new digital pathology algorithms to support cancer assay use in clinical trials. Roche Digital Pathology will create an artificial intelligence (AI) based image analysis algorithm to assist pathologists in interpreting the company’s FDA-approved Ventana D-L1 (SP142) assay for urothelial carcinoma patients. BMS will use the algorithm to generate biomarker data from clinical trial samples.
Zeta Surgical Inc. has raised $5.2 million in seed funding to improve the accuracy and safety of image-guided surgical procedures through its Zeta neurosurgical navigation platform. Zeta CEO Jose Maria Amich told BioWorld the funding will also advance a non-invasive ultrasound system for imaging the brain and help complete initial clinical studies for its FDA approvals application.
After two years of developing its platform, Vesalius Therapeutics Inc. now has $75 million in its pocket from Flagship Pioneering to understand and treat the diseases that account for 90% of the world’s illnesses. To resolve this massive amount of biological and industry complexity, Doug Cole, Vesalius’ chairman and co-founder and Flagship’s managing partner, noted the distinction between illness and disease. “Illness is what bothers you, it’s the experience of being sick and what the doctor might find when you’re examined,” Cole told BioWorld. “Disease is the mechanistic problem with the biology underlying the illness.”
