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Regulatory actions for May 6, 2024

May 6, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Masimo, Outset, Phonak, Scientia, Zygofix.
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Med-tech gainers and losers for April 29-May 3, 2024

May 3, 2024
The top 10 med-tech stock gainers and losers for the week.
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Blood cells and bacteria

Cytovale’s Intellisep rules out sepsis in 97.5% of cases

May 3, 2024
By Annette Boyle
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%.
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U-RHYTHM

Dynamic Therapeutics aims to transform hormone measurement with U-Rhythm

May 3, 2024
By Shani Alexander
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.
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DNA in drug capsules, digital background

US PTO taking up artificial intelligence’s patent noise problem

May 3, 2024
By Mark McCarty
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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Flag of Australia, sky background

Australia poised to harness the power of radiopharmaceuticals

May 3, 2024
By Tamra Sami
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.
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Apple Computer Inc. logo

FDA qualifies Apple atrial fibrillation history feature as an MDDT

May 3, 2024
By Holland Johnson
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.
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Appointments and advancements for May 3, 2024

May 3, 2024
New hires and promotions in the med-tech industry, including: Karius, Probo Medical.
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Financings for May 3, 2024

May 3, 2024
Med-tech firms raising money in public or private financings, including: Aditxt, Aisap, Karius.
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In the clinic for May 3, 2024

May 3, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Omeza, Natera.
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