Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds. Read More
The first special purpose acquisition company (SPAC) merger announced in 2023 has fallen apart. Aprinoia Therapeutics Inc. and Ross Acquisition Corp. II mutually agreed to call off the merger that had been valued at $280 million. The failed deal is part of a larger trend that has gained momentum in the past year as a struggling economy and tighter U.S. SEC restrictions dampened SPAC deals. Read More
Curvebeam AI Ltd. made its debut on the Australian Securities Exchange (ASX:CVB) after raising AU$25 million (US$16.175 million) in an initial public offering that will allow the company to market its flagship Hirise weight-bearing CT scan solution globally. Read More
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024. Read More
The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In Vitro Diagnostic Regulation (IVDR). Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspen Neuroscience, Bostongene, Caresimple, Emerald Innovations, Heartsciences, Japan Industrial Partners, NEC, Panaceaflo, Rune Labs, Salvia Bioelectronics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Paragonix. Read More
