Regulatory
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Extremities
Ortho Consulting Group Hosts Webinar Discussing How to Successfully Navigate the Medical Device Industry’s Regulatory Challenges Selling into the UK Post-Brexit
Ortho Consulting Group is hosting a webinar discussing how to successfully navigate the medical device industry’s regulatory challenges for medical…
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Financial
Stryker announces receipt of all required regulatory approvals for proposed acquisition of Wright Medical
Kalamazoo, Michigan, Nov. 04, 2020 (GLOBE NEWSWIRE) — Stryker (NYSE: SYK) announced today that all required regulatory approvals have been…
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Neuro
MCRA Hires Former Leader of FDA Breakthrough Device Program & Neurology Division Manager
WASHINGTON, Oct. 8, 2020 /PRNewswire/ — MCRA, LLC, a leading medical device and biologics advisory firm and clinical research organization (CRO) integrating…
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Biologics
Cerapedics Announces Canadian Approval of its next-generation bone graft
Canada will be the first commercial market to launch i-FACTOR®+ Matrix WESTMINSTER, Colo., September 15, 2020 — Cerapedics, a private…
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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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