Tensive S.r.l. raised €14 million (US$14.5 million) in a series A financing round for its bio-absorbable breast implant Regenera, for patients undergoing reconstructive surgery after lumpectomy. The funds will be used to complete a pivotal clinical trial to evaluate the safety and performance of the technology. Read More
Harmonized regulations for laboratory-developed tests (LDTs) across Asia Pacific are sorely needed at a time when LDTs continue to play a critical role in addressing unmet needs in the region, according to a recent whitepaper developed by APACMed. Read More
A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also supports the notion that there is no point in reinventing a highly functional regulatory wheel. Read More
Implanted patches of iPS cell-derived heart muscle integrated with heart tissue in a primate model of heart failure, and in patients being treated in a clinical trial, marks progress toward a potential option for patients with advanced heart failure. Read More
In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the individualized management of immune-mediated inflammatory diseases such as inflammatory bowel disease and irritable bowel syndrome. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Augnito, Almoosa Health, GE Healthcare, Kromek, Retrieve Medical, Siemens Healthineers. Read More
