Regulatory

OrthoPediatrics Corp. Files Sanctions Motion Against a Former Employee and WishBone Medical, Inc.

WARSAW, Indiana, Jan. 02, 2019 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, today issued a statement from Daniel Gerritzen, Vice President and General Counsel, concerning actions it filed against Robert von Seggern, a former employee, and WishBone Medical, Inc. in an Indiana state court in

By |2019-01-02T22:46:44+00:00January 2nd, 2019|Regulatory|

Hospital prices are about to go public

Dec 26, 2018 / By: Kaitlin Schroeder, Journal-News.com Prices hospitals charge for their services will all go online Jan. 1 under a new federal requirement, but patient advocates say the realities of medical-industry pricing will make it difficult for consumers to get much out of the new data. A federal rule requires all hospitals to post online a

By |2018-12-26T18:09:37+00:00December 26th, 2018|Regulatory|

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

December 20, 2018 / FDA News Release The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may

By |2018-12-20T16:57:53+00:00December 20th, 2018|Regulatory, Top Stories|

Ex-Cleveland Clinic Innovations head sentenced to 30 months in prison for role in $2.7M fraud case

Dec 19, 2018 / Paige Minemyer The former head of Cleveland Clinic Innovations, who pleaded guilty to defrauding the health system out of nearly $3 million, was sentenced to 30 months in prison. Gary Fingerhut, 58, was also ordered to pay the more than $2.7 million that was diverted from the Cleveland Clinic as part of

By |2018-12-20T16:26:28+00:00December 20th, 2018|Regulatory|

NuVasive Grows Cervical Spinal Interbody Portfolio With PEEK Corpectomy Implant

SAN DIEGO, Dec. 10, 2018 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of its Monolith®Corpectomy System, providing surgeons with a modular PEEK interbody solution for

By |2018-12-10T15:24:11+00:00December 10th, 2018|Regulatory, Spine, Top Stories|

IntraFuse Granted US Patent for FlexThread™ Intramedullary Fracture Fixation System

LOGAN, Utah, Dec. 6, 2018 /PRNewswire/ -- IntraFuse, a start-up medical device company operated by Surgical Frontiers, is focused on advanced surgical devices for improving outcomes for orthopedic extremity procedures, announced today that the United States Patent and Trademark Office has recently granted the company a key patent related to its FlexThread™ Intramedullary Fracture Fixation system. US Patent 10,136,929

By |2018-12-06T17:05:52+00:00December 6th, 2018|Regulatory, Top Stories|

Hospitals sue over site-neutral payment policy

By Susannah Luthi  | December 4, 2018 The American Hospital Association on Tuesday led a lawsuit against the Trump administration over the CMS' final rule imposing a site-neutral payment policy, which cuts some Medicare rates for outpatient hospital sites to match the rates for physicians' offices. The lawsuit, filed in the U.S. District Court for the District of Columbia, challenges

By |2018-12-05T15:57:26+00:00December 5th, 2018|Regulatory|

Carmel spine surgeon wins $112M verdict in royalty battle with Medtronic

November 30, 2018 / John Russell Dr. Rick C. Sasso, an Indiana spine surgeon and inventor, has won a sweeping, five-year legal battle against medical-device giant Medtronic, with a jury this week awarding him $112 million in damages. Sasso, 58, president of Carmel-based Indiana Spine Group, had claimed that Medtronic had violated a contract by not

By |2018-11-30T22:48:17+00:00November 30th, 2018|Regulatory|

Histogenics and FDA Continue to Discuss NeoCart® Phase 3 Clinical Trial Data and Potential Regulatory Pathway

WALTHAM, Mass., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today provided an update on the NeoCart regulatory pathway based on its ongoing dialogue with the U.S. Food and Drug Administration (the FDA).  Since

By |2018-11-29T15:37:14+00:00November 29th, 2018|Regulatory|

FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain

November 28, 2018 HOUSTON--(BUSINESS WIRE)--SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced the FDA has cleared its Investigational New Drug (IND) protocol for human trials in the U.S., considered to be the first IND approval for a fibroblast cell therapy

By |2018-11-28T16:44:11+00:00November 28th, 2018|Regulatory|