A new assay developed by Metadeq Inc. may be bringing the days of the invasive liver biopsy for non-malignant conditions to a close. The company’s liquid biopsy successfully used the presence of two proteins in blood to identify and stage non-alcoholic steatohepatitis (NASH) and liver fibrosis in a study published in Gut. Read More
Microport Neurotech Ltd.’s shares started at HK$24.7 (US$3.15) per share, fell 0.162% and closed at HK$24.60 apiece on its first day of trading of July 15, 2022. Read More
Ophthalmic and microsurgery device maker Carl Zeiss Meditec AG is investing in regenerative medicine startup Precise Bio Ltd. to jointly develop 4D bio-fabricated corneal transplants for diseases that require endothelial keratoplasty and natural lenticule transplants. Under the terms of the agreement, Carl Zeiss Meditec will lead a series B financing round in Precise Bio and fund development of two cornea transplant products. Read More
Reliance Medical Systems LLC agreed to pay $1 million to address allegations of violation of the Anti-Kickback Statute (AKS), but the company has responded to that outcome with a blistering riposte. Read More
A “clean” user fee bill with no congressionally added policy riders. It’s been a biopharma and med-tech dream for years. But now that U.S. Sen. Richard Burr (R-N.C.) has introduced such a bill, it could prove a nightmare, given competing legislation and the tight timetable for reauthorizing the user fee programs before the clock winds down on the current agreements Sept. 30 when fiscal 2022 ends. Read More
The U.S. federal government’s crackdown on companies in the health care space shows no signs of slowing down as indicated by an announcement by the Department of Justice (DOJ) that it has achieved a settlement with Opko Health Inc. and Bioreference Health LLC regarding allegations of induced referrals. Read More
Med-tech financings in the second quarter of 2022 rose from last quarter by 26% with a total $8.5 billion raised, the most for a Q2 in all years prior to 2020. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinity DNA, BD, Edap, Genetic Technologies, GE, Grail, Nateria, Parata, Zoll. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Radialis, Werfen. Read More
