Robert A. Herrmann’s Post

MCRA is pleased to announce its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve the SurVeil™ drug-coated balloon (DCB) to treat peripheral artery disease (PAD). MCRA’s Regulatory and Biocompatibility experts collaborated closely, enabling MCRA to both develop the robust technical discussions and then articulate them to FDA in terms of safety, effectiveness and favorable benefit-risk profile. Read the full press release on our website now. Surmodics, Inc. #mcra #pma #cardiovascular #medtech #biocompatibility #fda #medicaldevices #news

MCRA delivers #clinicalstudy success stories. #medtech companies across the world trust MCRA for their #clinicalresearch support needs. Our world-class expertise unlocks multiple barriers to success, resulting in improved #clinicaltrial rates and greater client satisfaction. Learn how we can help you advance your medical technology goals. Contact Our CRO Team to Learn More https://lnkd.in/ehwSCmAm

FDA clearance/approval does not equal patient access! Payers Need Clear Outcomes Data to Reimburse Digital Health, Experts Argue It’s clear that services like telehealth and remote patient monitoring have potential to provide value within the healthcare industry, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce in order to earn reimbursement, panelists argued during MedCity's INVEST conference. https://lnkd.in/d5NcCjGW

Meet MCRA: Devjani Saha, Director of Neurology Regulatory Affairs  Dr. Saha is a biomedical engineer by training with over 6 years of FDA experience and over 10 years of research experience in brain computer interfaces, medical robotics and neurostimulation devices. While working at the FDA, Dr. Saha contributed to the development of the several policies and guidances, including the leapfrog guidance on brain computer interface, policies for the regulation of wearable devices for physical rehabilitation, and standards supporting exoskeleton pre-clinical testing. She also was a policy lead for the Real World Evidence initiative at the FDA and helped to launch the Safer Technologies Program (STeP) and provided programmatic expertise during the review of STeP submissions.  Learn more about Dr. Saha and their work on our website: https://lnkd.in/erf5Y9SE #mcra #meetmcra #fda #neuroscience #medicaldevices #regulatoryaffairs #robotics #braincomputerinterface #medicalrobotics #neurostimulation #exoskeleton #medicaldevice #regulatory #regulatoryrequirements #regulatorycompliance