Regulatory
-
Hospitals
Massachusetts system pays DOJ $1.9M after employee theft reveals drug inventory inaccuracies
By Dave Muoio – Dec 8, 2022 A Massachusetts health system has agreed to a nearly $2 million settlement with the…
Read More » -
Hospitals
FTC notches another antitrust win as HCA Healthcare, Steward Health Care call off 5-hospital sale
By Dave Muoio – Jun 17, 2022 The Federal Trade Commission is two-for-two this month on hospital merger challenges, announcing Thursday…
Read More » -
Spine
SpinaFX Hits Key Milestones Since Closing its $6.88M Series A Round
Acquires intellectual property to support pursuit of regulatory approval for innovative treatment TORONTO, May 26, 2022 /PRNewswire/ – Minimally invasive image-guided therapy…
Read More » -
Regulatory
Medtronic names new chief scientific, medical, and regulatory officer
Dr. Laura Mauri will drive integration of medical and scientific intelligence and patient safety and engagement as chief scientific, medical and regulatory…
Read More » -
Biologics
BioRestorative Therapies Announces the Appointment of Robert Paccasassi to Vice President of Quality Assurance/Regulatory Compliance
MELVILLE, N.Y., Jan. 11, 2022 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ:BRTX), a life sciences company…
Read More » -
Biologics
MCRA Expands International Regulatory Team
Peter Bowness, Ph.D., former British Standard Institution (BSI) senior regulator and decision maker joins MCRA as Director, International Regulatory Affairs…
Read More » -
Regulatory
Titan Medical Announces Appointment of Tammy Carrea as Vice President of Quality and Regulatory Affairs
August 2, 2021 TORONTO–(BUSINESS WIRE)–Titan Medical Inc. (Nasdaq:TMDI; TSX: TMD), a medical device company focused on the design and development…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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…
Read More » -
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,…
Read More »