Preparing For Your Clinical Evaluation Report
Preparing For Your Clinical Evaluation Report Aligning with MEDDEV 2.7.1 and the MDR The newest revision has defined, clarified and tightened guidance on clinical evidence requirements for unapproved technologies as well as products that have been on the market for an...
read more4 Steps to Deploy a Cybersecurity Postmarket Strategy
While the development of innovative technologies and connected devices continues to flourish, public concern surrounding cybersecurity has increased significantly in recent years.
read moreTips from Corporate Strategy Experts
As the medical device industry changes, companies are looking to achieve sustainable growth and business development.
read moreWhat Is Healthy?
With the new regulations, industry professionals have the unique opportunity to explain themselves and be clear about what claims are important for health today.
read morePBMs Hold the Key to Pharmaceutical Success
Recent debates surrounding drug pricing have forced the pharmaceutical industry to navigate multiple avenues ensuring optimal coverage while maintaining high levels of ROI. Though the industry has worked extensively with insurance providers, building positive...
read moreLibby Jenkins – Bayer CropScience LP
Executive Leadership Support Forum: Raleigh-Durham: Speaker Interview
read moreKim Howington – Teleflex
Executive Leadership Support Forum: Raleigh-Durham: Speaker Interview
read moreAnne Belote – University of North Carolina at Chapel Hill
Executive Leadership Support Forum: Raleigh-Durham: Speaker Interview
read moreChase Hensel – Welkin Health
8th Annual Life Science Chief Executive Officer Forum: Speaker Interview
read moreMark Throdahl – OrthoPediatrics Corp.
8th Annual Life Science Chief Executive Officer Forum: Speaker Interview
read moreLupin Receives FDA Approval for New Cholesterol Drug
Lupin has received an FDA approval for its cholesterol drug, Nikita Pitavastatin. The drug, which received a new drug approval from the agency, is poised as the latest treatment for patients suffering from primary hyperlipidemia or mixed dyslipidemia by lowering total...
read moreAum Cardiovascular Grabs FDA Node for Heart Monitoring Device
Aum Cardiovascular has secured FDA approval for its cardiovascular device, Cadance. The device, which is to be used in a primary care setting, applies an algorithm to the natural acoustics of the heart. This will allow doctors to adequately diagnose...
read moreAbiomed Reports Share Increase After Lower than Expected CMS Cuts
Abiomed has announced a rise in shares due to a less-than-expected CMS cut to reimbursements for the company’s heart pump, Impella. The Centers for Medicaid and Medicare Services initially proposed a 35% cut to reimbursement, but only 19% was actually...
read moreCRISPR Technology Reaches Breakthrough in Embryo Gene Editing
Scientists have reportedly successfully edited the genes of embryos to repair a serious disease mutation without damaging the embryos. The study, which was recently published in the journal, Nature, indicates a breakthrough in the biotechnology industry...
read moreCONTACT US
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