New guidance by the Medical Device Coordination Group spells out many of the routine aspects of compliance with the In Vitro Diagnostic Regulation, but test developers should remain aware of the tripwires in connection with modifications to both the test and the test’s performance studies. Read More
Modi Ventures closed its second fund with total commitments of $88 million as it continues its mission to invest in companies at the intersection of artificial intelligence, biology and medical technology. The venture capital firm sees the future of health care as a convergence of these technologies. Read More
South Korea’s Ministry of Food and Drug Safety signed a confidentiality agreement with Japan’s Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to boost bilateral regulatory cooperation in the field of medical devices. Read More
There are times when a casual observer can’t tell whether the medical device industry’s messaging is getting through to policymakers, but a July 17 announcement by the Trump administration clearly signals the effectiveness of at least one med tech messaging strategy. Read More
Following up on the $175 million it raised in September 2023, Avalyn Pharma Inc. secured an additional $100 million in an oversubscribed series D financing round to support development of its inhaled treatments for pulmonary fibrosis. Read More
Five years after the COVID-19 pandemic virtually locked down the U.S. government and society in general, the Patent Trial and Appeal Board (PTAB) is shedding the last vestiges of those days. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Elekta, Imperative, Philips, Roche. Read More
