Sanchita Bose

Nov 14, 2024 | jdsupra.com | Eman Al-Hassan |Sanchita Bose |Robert Church

November 14, 2024 Eman Al-Hassan, Sanchita Bose, Robert Church, Heidi Forster Gertner, Ashley Grey, Blake Wilson Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: [co-author: Lauren Massie, Evelyn Tsisin] The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting,...

Dec 7, 2023 | jdsupra.com | Sanchita Bose |Michael Druckman |Kristin Zielinski Duggan

The proposed rules, Rule 1 and Rule 2, would implement classification of currently unclassified, pre-amendments wound dressings and liquid wound washes containing antimicrobials and/or other chemicals. Such products are currently regulated through the 510(k) pathway. The proposed classification is informed largely by feedback taken from previous FDA panel meetings held in 2005 and 2016, which we summarized online here.

Nov 20, 2023 | jdsupra.com | Lauren Battaglia |Sanchita Bose |Ashley Ifeadike

As part of the MedTech conference, MedTech Color hosted its 6th Annual networking breakfast, bringing together professionals of color and allies in the medical technology space. Tania Saison of Edwards Lifesciences was the keynote speaker at the MedTech Color networking breakfast, delivering a powerful speech on her path to her current leadership role and the hurdles that she faced as a diverse person and lawyer, many of which resonated with us as diverse lawyers.

Sep 1, 2023 | jdsupra.com | Sanchita Bose |Randy Prebula

There are two main types of brain stimulation devices: Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) devices. DBS medical devices treat neurological disorders, such as Parkinson’s disease, essential tremor, and other neuropsychiatric conditions. Specifically, DBS devices require an invasive surgery that involve physicians implanting one or more electrodes or “leads” into targeted regions of the brain.