Regulatory
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Extremities
HSS Innovation Institute: 360-Degree Support
by Elizabeth Hofheinz, M.P.H., M.Ed. Few people can argue with the business wisdom that says to surround yourself with talented…
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COVID-19
FCC grants GE Healthcare waiver to expedite medical equipment during COVID-19 pandemic
May 12, 2020 / Jeff Lagasse, Associate Editor The Federal Communications Commission today granted GE Healthcare’s request for a waiver to…
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Hospitals
Silony Medical’s Process Advisory Board
by Elizabeth Hofheinz, M.P.H., M.Ed., April 24, 2020 What can a scrub tech tell you about instrument design? Quite a…
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COVID-19
MCRA Launches Medical Device U.S. FDA Regulatory & Clinical Trial Advisory Support & Call Center to Assist with the COVID-19 Pandemic
WASHINGTON, March 24, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device advisory firm and CRO with specialization in regulatory affairs, clinical research,…
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COVID-19
Here are 3 drugs in development to fight coronavirus, 2 vaccines and one ‘passive’ vaccine
March 19, 2020 / By Emily R. Siegel Finding a vaccine for coronavirus has become a public health priority, and pharmaceutical…
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Regulatory
Zimmer Biomet warns on some StageOne bone spacer molds
MARCH 17, 2020 – By SEAN WHOOLEY Zimmer Biomet (NYSE:ZBH) issued an urgent field safety notice in Europe to warn on certain StageOne…
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Financial
MCRA Strengthens its Reimbursement, Health Economics, and Market Access Division with the Hiring of Tess Wong, MS
WASHINGTON, Jan. 16, 2020 /PRNewswire/ — MCRA, LLC, is a leading clinical research organization (CRO) and advisory firm specializing in medical devices and…
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Financial
Reactions to Congressional Repeal of Medical Device Excise Tax
by Elizabeth Hofheinz, M.P.H., M.Ed., December 17, 2019 It looks like roughly 21,000 American jobs are safe. An analysis by…
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Financial
Medical device tax on track for permanent repeal
December 16, 2019 / By NANCY CROTTI A bipartisan spending bill unveiled today by Congressional leaders would permanently repeal the 2.3%…
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Biologics
Anika Appoints Mira Leiwant as Vice President of Regulatory Affairs, Quality, and Clinical Affairs
October 14, 2019 BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated company, focused on developing regenerative therapies leveraging its…
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Hospitals
Lawmakers hoping to overhaul privacy rules for substance-use disorders
August 14, 2019 / SUSANNAH LUTHI Lawmakers are hoping Congress can pass a proposed overhaul of addiction-related privacy laws now that the…
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Financial
More clinical evidence needed to accelerate adoption of AI-enabled decision support: report
Jan 28, 2019 / by Heather Landi Artificial intelligence-enabled clinical decision support (CDS) has the potential to equip clinicians with the…
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Hospitals
MiMedx Receives Regulatory Approval to Commercialize Product Portfolio in Australia
MARIETTA, Ga., Aug. 9, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced…
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Hospitals
Emergo Survey: Regulatory Issues Remain Biggest Challenge for Most Medical Device Companies
February 27, 2017 by Stewart Eisenhart EMERGO SUMMARY OF KEY POINTS: Regulatory issues continue to be the biggest business challenge…
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Hospitals
Medical Device Violations: FDA Launches Portal to Report Regulatory Misconduct
Author: Heather Maver – December 7th, 2016 The FDA recently launched a portal for individuals to report allegations of regulatory…
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