Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Masimo, Outset, Phonak, Scientia, Zygofix.
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
Dynamic Therapeutics Ltd. is looking to commercialize its U-Rhythm technology which it hopes will transform the way hormones are measured. U-Rhythm, a portable device which collects biochemical samples from the patient throughout the day, will significantly change the diagnosis and treatment of many diseases, Stafford Lightman, co-founder of Dynamic Therapeutics told BioWorld.
Recent advances in artificial intelligence (AI) have generated a tsunami of popular dystopian musings, but the U.S. Patent and Trademark Office (PTO) has its own concerns about AI’s impact on intellectual property. PTO recently announced that it is looking for feedback on the use of AI to produce what litigants might spuriously claim is prior art, a concern that must be addressed if the patent system is to avoid crashing under the weight of an unmanageable volume of AI-generated clutter.
Australia is poised to play a leading role in the rise of the global radiopharmaceutical industry, as advanced therapies drive significant investment and rapid expansion, according to a new discussion paper from industry accelerator Mtpconnect.
Apple Inc. said the U.S. FDA has approved the Apple Watch's atrial fibrillation (AF) history feature under its rigorous Medical Device Development Tools (MDDT) program that specifies what devices health professionals can rely on.