The epic rise and fall of Elizabeth Holmes, founder of Theranos Inc., will preoccupy the world of business for decades to come, but this story has also left a large footprint in the world of clinical diagnostics. David Stein, CEO of Babson Diagnostics Inc., of Austin, Texas, told BioWorld that investors are a bit more wary than usual because of the Theranos saga, forcing test developers to be more rigorous in test development and more transparent with investors about a test. Read More
Be careful who you’re doing business with. That’s the warning the U.S. Court of Appeals for the District of Columbia Circuit sent this week to multinational drug and device companies doing business in terrorist hot spots around the world. Reversing a lower court, the D.C. Circuit cleared the way Jan. 4 for 21 drug and device companies to potentially be held accountable for doing business with Jaysh al-Mahdi terrorists, operating through the Iraqi Ministry of Health, who injured or killed hundreds of U.S. troops and civilians in Iraq. Read More
Investors including SOSV, Cultivate(MD), Wavemaker360 Health, Blu Venture Investors and Broad Street Angels are backing Strados Labs LLC with $4.5 million. The pre-series A funding will be used to accelerate development of the company’s smart sensor platform Resp. The funding comes after Strados received FDA clearance for the product in December 2021 and brings its total raised to $7 million. Read More
Cancer trials that stratify patients using biomarkers increase their likelihood of proceeding to the next phase more than 500% compared to trials run without biomarkers, Canadian researchers recently determined, and biotech companies have invested heavily in identifying new biomarkers for a wide range of applications. Genialis Inc. has tackled the problem of huge investment in biomarkers with little return by developing a platform that combines artificial intelligence and machine learning. Read More
China’s med-tech products exports declined in 2021 as manufacturing in other countries picked up, while med-tech imports to the country increased. In the first half of 2021, China’s med-tech exports amounted to $47.931 billion, a decrease of 23.1% year-on-year. But imports for the same period amounted to $24.392 billion, an increase of 25.2% year-on-year, according to med-tech data company Guangzhou Joinchain Big Data Technology Co. Ltd. Read More
The U.S. Patent and Trademark Office (PTO) has been scrambling to adjust to recent developments in case law for patent subject matter eligibility, and the latest PTO response is a pilot program for new patent applications. Read More
New hires and promotions in the med-tech industry, including: Avellino Labs, Bluejay Diagnostics, Gattaco, Miromatrix Medical, Myriad Genetics, Summit Biolabs. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagio, Akoya, Applied Medical Solutions, Bio-Techne, Bosch, Cardx, Diacarta, Highmark Health, Laborie Medical, Metavention, Nanovibronix, Neovasc, Nuvo, Thermo Fisher Scientific, The Transplant Pharmacy. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endotronix, Nuvasive. Read More
