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BioWorld - Tuesday, July 28, 2026
Home » Topics » Medical technology

Medical technology
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U.S. FDA headquarters

FDA issues patent term extension data for multiple devices

Feb. 13, 2024
By Mark McCarty
The U.S. FDA has posted information on the regulatory review period for several medical devices that incorporate patented inventions, such as the determination for the Simplify artificial cervical disc by Simplify Medical Inc., of Sunnyvale, Calif. According to the FDA, the company seeks to tack nearly 1,100 days back on to the patent in question, an additional three years that may play a significant role in the company’s attempt to monetize the patent in question.
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Uspto seal

US PTO guidelines for AI suggest amplified need for documentation

Feb. 13, 2024
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.
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Omnipod 5

Insulet integrates Abbott Libre 2 with its Omnipod 5 in Europe

Feb. 13, 2024
By Shani Alexander
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
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Samsung Galaxy Watch

FDA approves Samsung’s sleep apnea feature on Galaxy watch, phone

Feb. 13, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved a new feature for detecting obstructive sleep apnea (OSA) on the Samsung Galaxy watch and smartphone, Samsung Electronics Co. Ltd. said on Feb. 10.
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Masimo MightySat pulse ox

FDA hands Masimo first clearance for medical-grade OTC pulse ox

Feb. 13, 2024
By Annette Boyle
Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same technology as Masimo’s Set pulse oximetry used in hospitals and clinics.
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Masayo Takahashi, CEO, Vision Care
Ocular

Newco news: Vision Care’s iPS retinal cells primed for global market

Feb. 13, 2024
By Tamra Sami
Vision Care Group CEO Masayo Takahashi led the world's first clinical study of a retinal cell transplant derived from induced pluripotent stem cells (iPS cells) in 2014 when she led the Laboratory for Retinal Regeneration at Japan’s Riken Center for Biosystems Dynamics Research. In 2019, she founded Vision Care and subsequently founded two subsidiary companies dedicated to developing cell and gene therapies.
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Med-tech gainers and losers for Feb. 5-9, 2024

Feb. 12, 2024
The top 10 med-tech stock gainers and losers for the week.
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Regulatory actions for Feb. 12, 2024

Feb. 12, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Orano Med, Radiomedix, Samsung Electronics, T2 Biosystems.
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Other news to note for Feb. 12, 2024

Feb. 12, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ascensia, Binx, Cardinal Health, Emed, Imaware, Link, Science 37, Sensome, Think Surgical.
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In the clinic for Feb. 12, 2024

Feb. 12, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Mediwound.
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