Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Immunovia, Roche.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avesthagen, Calibermri, Claron Health, Congenica, Lucira, Medicines Discovery Catapult, Natera, Scanslated, Unidoc, Zeiss.
The notion of a device that disappears from the human body once its work is done has driven massive investments in bioresorbable coronary artery scaffolds and stents, but these devices have had a difficult time getting to and staying on the market. The U.K. National Institute of Health and Care Excellence determined recently that these devices are not ready for routine use and should be deployed only in clinical trials.
President Joseph Biden signed into law the CHIPS and Science Act of 2022, a bill that calls for investment of $280 billion overall into the development and manufacturing of semiconductor products and which should ease the crunch on these products for medical device manufacturers. However, some have estimated that bringing new production capacity online can take three to five years, suggesting that the med-tech industry will need to continue to devise workarounds to the current supply crunch for the immediate future.
Ipreg Inc. developed a sperm-sorting chip to increase the fertility rate and fill in the blind spots that come with the in vitro fertilization (IVF) process. The chip also increases the purity of healthy sperm to 90% while posing minimum damage to the DNA.
Syncthink Inc. is preparing to launch its neurological impairment and disease diagnostic in Europe, after securing CE marking for the ocular biomarker device. The company is raising a new round of funding to support commercialization of the Eye-Sync system and has two projects exemplifying applications of the device running with academic collaborators in the U.K.
Dartmouth College spinoff Nanopath Inc. closed a $10 million series A funding round to commercialize a point-of-care biosensing platform with ultrasensitive optical detection. The startup is developing a rapid test that provides genetic information in less than 15 minutes without the need for nucleic amplification. To date, the company has generated preliminary data in two clinical indications focused on women’s health: human papillomavirus genotyping and urinary tract infection characterization.
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