The new year kicked off with good news from the U.S. FDA for Onconano Medicine Inc. The agency granted the company’s pH-sensitive fluorescent nanoprobe, pegsitacianine, breakthrough therapy designation for use as an adjunct for visualization of metastases in the peritoneal cavity. Read More
Intellectual property continues to be a pressing issue for makers of medical devices and diagnostics as demonstrated by the ongoing patent dispute between Alivecor Inc., and Apple Inc., which is being waged on multiple fronts. An administrative judge at the International Trade Commission (ITC) sided with Alivecor in the dispute, opening the door to an import ban while the Patent Trial and Appeal Board found that 20 of the claims in the disputed patent are unpatentable. Read More
Sonoscape Medical Corp. obtained marketing approval in China for its intravascular ultrasound (IVUS) diagnostic device and intravascular ultrasound diagnostic catheter. Read More
Bottneuro AG closed the first tranche of a bridge round, bringing its total capital raise in 2022 to $4.3 million. This is being used to develop its noninvasive, domestic therapy for treating early moderate-stage Alzheimer’s patients. Read More
The process used by Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office PTO) to review patent disputes has become an issue yet again, thanks to a report by the Government Accountability Office (GAO). According to the GAO report, 75% of respondents to a survey of PTAB judges said that oversight practiced at PTO affected their independence in adjudicating cases, but that view was not universally held by these judges, leaving stakeholders with a vague picture as to the nature of the processes handled by the PTAB. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent Technologies, Avida Biomed Health, Cadence, Carmat, Collplant, GE, GE Healthcare, Inhibrx, Lucira, Northstar Medical Radioisotopes, The Binding Site, Thermo Fisher, Utitec. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bresotec Medical, Imperative Care, Onconano Medicine, Sedana Medical. Read More
