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Researchers Develop Face Mask for Detection of SARS-CoV-2 - Knobbe Medical According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus that causes COVID-19, via a user’s breath. Instead of relying on a lab, the personal device uses sensors that use wearable freeze-dried cell-free (wFDCF) ...

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FDA Taking Steps to Prevent Future Medical Device Shortages - Knobbe Medical The medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic. Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices. As Janet Woodcock, M.D., the Acting Commissioner of Food and Drugs, acknowledges in her Jul...

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Supreme Court Upholds, but Limits, Patent Infringement Defense of "Assignor Estoppel" - Knobbe Medical The U.S. Supreme Court recently decided a case resolving a patent dispute between two medical device companies, Hologic, Inc. and Minerva Surgical. The opinion was closely watched because it raised the question of whether an inventor who has assigned a patent is legally prevented from later attackin...

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Nephros Acquires GenArraytion for $1.2 million - Knobbe Medical "[T]he acquisition propels Nephros' position in the PCR testing market for waterborne pathogens."

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Is your funded medical device startup actually a "large entity" according to the USPTO? - Knobbe Medical Even small startups can be "large entities" to the USPTO for the purposes of fees. It's important to know when such situation might apply.

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Conformis Continues Litigations Against Patient-Specific Medical Technologies - Knobbe Medical On June 3, 2021, Conformis continued its patent enforcement efforts involving patient-specific technologies by filing suit against Bodyhub and Exactech in the Middle District of Florida. In a first complaint, filed against Exactech, Conformis accused Exactech’s Vantage® Total Ankle System of infr...

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UCLA Biodesign Launches Study to Help Advance MedTech and Digital Health Innovation Forward Into a New Decade - Knobbe Medical What does it require to bring a transformational innovation to patients? To address this question, the UCLA Biodesign Hub for MedTech and Digital Health has launched an industry-wide study to uncover the cost and time to achieve regulatory and reimbursement approval in the United States and to under...

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Philips Acquires BioTelemetry for $2.8B - Knobbe Medical Royal Philips NV acquired BioTelemetry, Inc. for $2.8 billion US dollars. Headquartered in Malvern, Pennsylvania, BioTelemetry provides cardiac diagnostics and monitoring tools that, according to the press release, are expected to add to Philips’ line of hospital-based patient monitoring solutions...

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Boston Scientific Exercises Option to Acquire Transcatheter Annuloplasty Ring Developer Millipede Inc. - Knobbe Medical Global medical device company Boston Scientific has announced on December 27, 2018, that it exercised its option to acquire remaining shares of privately-held medical device company Millipede, Inc. upon its recent successful completion of a first-in-human clinical study. Boston Scientific previously...

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Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic "Jervis" Patent - Knobbe Medical On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.” The ‘141 Paten...

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Cryoablation Competition Heats Up - Knobbe Medical Atrial fibrillation (AF), a common heart rhythm disorder, is often treated with cardiac ablation. Cardiac ablation uses RF (heating) or cryothermal (cooling) energy to scar the areas of the heart muscle that are responsible for the abnormal heart rhythm. Abbott Laboratories, Boston Scientific, and B...

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Abbott Obtains FDA Approval for HeartMate 3 Device - Knobbe Medical Abbott announced on October 19, 2018 that its HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. Physicians now can offer the HeartMate 3 system to patients not eligib...