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Medical Device Blog Blog

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FDA Publishes Draft Ethical Consideration Guidance to Protect Children Participants in Clinical Trials of Medical Products

USA - September 30 2022 On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical trials…

AI and Cancer Diagnostics

USA - September 14 2022 Rather than simply reading radiological scans, Ibex Medical Analytics is employing its artificial intelligence (AI)-powered cancer detection…

WTO Agrees to Partial Patent Waiver for COVID-19 Vaccines

USA - June 23 2022 On June 16, 2022, the World Trade Organization (WTO) agreed to a partial waiver of intellectual property rights related to COVID-19 vaccines. The…

BD and Mayo Clinic Collaborate to Share De-Identified Patient Data

USA - June 13 2022 Becton, Dickinson and Company (BD) has partnered with Mayo Clinic to gain access to de-identified patient data from Mayo Clinic Platform_Discover, as…

Medtronic and DaVita Join Forces for Kidney Health

USA - June 1 2022 Medtronic plc and DaVita Inc. are joining forces to form a new, independent medical device company to provide enhanced kidney health care. The new…

Medtronic acquires Intersect ENT, sells Fiagon to Hemostasis LLC as required by FTC

USA - May 18 2022 On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc. The transaction was only able to gain approval of…

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

USA - May 12 2022 On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program…

FDA Publishes Draft Medical Device Cybersecurity Guidance Amidst Continued Cybersecurity Concerns

USA - May 5 2022 On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity…

Niazi’s Patent Survives on Appeal: Federal Circuit Reverses In Part Lower Court’s Decision

USA - April 13 2022 On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St…

Becton Dickinson’s PureWick Wins Patent Infringement Suit Against Stryker’s Sage Products Related To Female External Catheters

USA - April 6 2022 PureWick Corp., a Becton Dickinson company, succeeded in its infringement lawsuit PureWick Corp. v. Sage Products LLC. PureWick’s lawsuit alleged…