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Elizabeth Orr

Managing Editor, Policy & Regulation

Washington, DC

Elizabeth leads a team of Medtech Insight reporters devoted to covering medical device and diagnostics regulation in the US and abroad. As a reporter, she focuses on FDA regulation, legislation, and legal issues. A graduate of the University of Maryland College Park, she worked for outlets including FDA News, DecisionHealth (formerly UCG) and the Washington Examiner before joining Medtech Insight in 2015. She lives in Arlington, VA, with her husband and children.

Latest From Elizabeth Orr

COVID-19 EUAs To Stay Active After Public Health Emergency Ends

Authorizations in place for diagnostics, personal protective equipment, and other products cleared for emergency use during the pandemic will remain in place until the potential for an outbreak no longer exists or products receive traditional clearances, according to a Federal Register notice issued by HHS this week.

Coronavirus COVID-19 Policy

News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More

News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.

FDA Policy

Pain Device Firm’s Undoing Over $16K ‘Piece of Plastic’

Neuromodulation company Stimwave has agreed to pay $10M in fines and the ex-CEO is facing health care fraud charges after a whistleblower revealed the company was selling a fraudulent “receiver” component. 

Regulation Enforcement

News We’re Watching – FDA Nixes Neuralink Trials, Layoffs at J&J, Novel Knee Implants

This week, we learned that the US FDA thinks Elon Musk’s Neuralink brain interface device isn’t ready for human trials.  Additionally, J&J cut about 300 medtech jobs, Stryker launched a knee implant, and Active Implants’ meniscus replacement device made it to the FDA’s advisory panel calendar. 

Regulation Commercial

More Cancer Cases Tied To Breast Implants, FDA Says

The US agency announced this week that it’s reviewing multiple reports of a form of carcinoma that arises in the scar tissue around a breast implant.

FDA Policy

CMS Officials Stress Coverage Decision Timeline At ACLA Panel

Device developers who want to ensure the best possible reimbursement for their products should be thoughtful in how they approach the US Centers for Medicare and Medicaid Services, agency officials said during a recent meeting.

Policy Medical Device
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