Stryker Corp. has won the FDA’s nod for an implantable balloon spacer to aid in the healing of torn rotator cuffs. The de novo clearance of the Inspace subacromial tissue spacer system comes more than a decade after the biodegradable shoulder repair implant first debuted in European markets. The minimally invasive Inspace device is intended for arthroscopy treatment of massive irreparable rotator cuff tears (MIRCTs).
Negotiations between the FDA and industry over the next device user fee are going on behind closed doors, but the agency’s summaries of these meetings suggest there are sharp disagreements. While the FDA continues to press industry on additional fees for the total product life cycle advisory program, industry’s dissatisfaction with the FDA’s fiscal management of the user fee program has prompted a demand for a one-off audit of the agency’s use of those user fees.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Istar Medical, Palliare.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coaptech, Tidal Medical.
Hoping to get Germany to drop its opposition to a proposed World Trade Organization (WTO) waiver of intellectual property (IP) rights, several U.S. lawmakers have asked to meet with German Chancellor Angela Merkel when she’s in Washington for a July 15 summit with President Joe Biden.
It’s more than 20 years since the tobacco firm Philip Morris International Inc. commissioned a controversial research paper, “Public Finance Balance of Smoking in the Czech Republic,” which infamously argued that smokers cut state health care expenditure by dying early. The paper was considered an outrage and led to a high-profile apology from the company, after being widely derided by politicians and commentators internationally. The company’s July 9 proposal to buy the respiratory diseases firm Vectura Group plc for $1.2 billion is already looking just as provocative according to U.K. politicians and anti-smoking groups, who are calling for the government to intervene to stop it going ahead.
The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.
The COVID-19 pandemic may have been largely responsible for the lower volume of enforcement activities against device makers in 2020, but the volume of these activities seems to be ramping up in 2021. Recently, the FDA posted a large batch of warning letters to device makers while the U.S. Department of Justice (DoJ) announced two new enforcement actions, including a $27 million fine to the operators of durable medical equipment distributorships for kickbacks, part of a growing set of signals that enforcement is back in vogue in the U.S.
TORONTO – Spino Modulation Inc., a subsidiary of Montreal-based med-tech company Spinologics Inc., has received breakthrough device designation for a vertebral body tethering (VBT) device to treat adolescent idiopathic scoliosis, one of three types of scoliosis that cause the spine to develop an abnormal curve.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: East End Medical, Stryker, Xenios.
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