The U.K. National Institute for Health and Care Excellence has posted an early value assessment review of digital technologies for the management of chronic obstructive pulmonary disease, giving the conditional nod to only one technology — the Mycopd app by London-based My Mhealth Ltd.
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.
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