Regulatory
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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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Hospitals
Antimicrobial Resistance Concerns Leach into FDA’s Classification of Wound Dressings Containing Drugs
Posted in Regulatory and Compliance by MDDI Staff on November 15, 2016 On September 20–21, 2016, FDA convened an advisory panel…
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