Medical device

Alexander (Sasha) Opotowsky, associate professor at Harvard Medical School and a cardiologist at Boston Children’s Hospital and Brigham and Women’s Hospital took time out to speak with BioSpace about advances in heart health, congenital heart disease (CHD), biopharma, and the Adult Congenital Heart Association (ACHA).
MagForce introduces practice-oriented, unique, multifaceted application training for the use of NanoTherm Therapy in treating brain tumors
Leading provider of premium medical devices and hygiene products successfully launchesSuprasorb® CNP P3 and Debrisoft Pad for the first time in the region
Article provides full data set of pivotal clinical trial showing that HEMOBLAST Bellows is clinically and statistically superior to control at achieving hemostasis
Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday, FDA Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.
Data Presented Today at LINC Reiterate Commitment to Patient Safety and Data Transparency
FDA
Biom’up has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its HEMOBLAST Bellows Laparoscopic Applicator for all minimally-invasive procedures. Biom’up submitted the premarket approval (PMA) supplement to the FDA in July, 2018.
A 2013 study that analyzes IPO withdrawals between 1999 and 2004 found that about 13 percent returned later for a successful IPO, 36 percent turned again to raising capital privately, and 42 percent either merged or were acquired by other companies—another common strategy for biotechs. And about 11 percent filed bankruptcy.
One area that pharma companies are now focusing on is bringing more tech into the industry. This is proving to be a smart idea as new technologies are already helping to revolutionize research.
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