TORONTO – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure.
PERTH, Australia – About seven years ago, Australia’s George Institute for Global Health conducted a study to find out how many people require dialysis for end-stage kidney failure compared to how many people receive treatment.
The Washington Legal Foundation’s (WLF) webinar on False Claims Act (FCA) litigation highlighted several developments in case law, including that non-relator FCA cases were up significantly in fiscal year 2020. However, Jay Stephens, an attorney with Kirkland & Ellis LLP, noted that Sen. Chuck Grassley (R-Iowa) has taken aim yet again at the materiality standard for false claims as spelled out in the Supreme Court’s Escobar, a move which if successful could amplify the federal enforcement focus on life science companies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: White House names pick for CMS administrator’s post; FDA posts advisory for pulse oximetry; CDC: Telehealth visits dropped over last half of 2020; CRS says user fee shares of total review costs on the rise; Federal Circuit kicks case back to PTAB.
If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD offers little detail in reaction to advisory hearing; FDA invites stakeholders to user fee negotiations; MHRA wary of paclitaxel.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Additive Orthopaedics, FX Shoulder, Medtronic.
A U.S. FDA advisory committee voted 14 nays to three ayes that the benefits of the Lutonix 014 drug-coated balloon (DCB) do not outweigh the risks in a panel proceeding peppered by problems with missing data and a lack of operator blinding. The panel widely saw the use of paclitaxel-eluting technologies in other areas of the vasculature as a reassurance that this device might perform as promised, but the outcome nonetheless leaves the sponsor with a new round of negotiations with the FDA as to how to move forward.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS commits more funds for testing, materials to fight pandemic; Medtronic announces recall of Valiant Navion; Florida man pleads guilty in DME fraud.
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