Abbott Halts Sales of Bioresorbable Vascular Stent

Abbott pulled its absorbable vascular scaffold Absorb from the market on Sep. 14, saying the product cost more to make than it earned. Read More

FDA Guidance Aims to Improve Demographic Data for Devices

The FDA released guidance to help the medical device industry analyze and report clinical study data on age, racial and ethnic subgroups, noting there is… Read More

FDA Seeks Ideas for Regulations to Cut Under Trump Policy

The FDA is asking stakeholders for help identifying federal requirements that can be repealed or replaced under the Trump administration’s deregulatory push. Read More

Protecting Devices From Cybersecurity Risks

With the recall of 465,000 Abbott pacemakers deemed at risk of getting hacked — marking the first ever device recall for a cybersecurity issue — it’s time for a deeper dive on how to protect your product from cyber risk. Read More

U.S., Brazil Add New Auditing Bodies for MDSAP

The FDA and Brazil’s National Surveillance Agency have added new auditing bodies to their list of organizations eligible to conduct quality management system audits for the Medical Device Single Audit Program. Read More

Warning Letter Roundup: FDA Flags Four Devicemakers

The FDA issued warning letters to four device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations. Read More

FDA Seeks Entrepreneurs to Join Digital Health Team

CDRH is looking for entrepreneurs to help the agency create digital health regulations. Read More

483 Roundup: FDA Finds Shortfalls at Four Device Facilities

The FDA found numerous GMP and other violations during inspections of four device manufacturing facilities. Read More

MDISS Unveils First of Many Device Security Testing Labs

The Medical Device Innovation, Safety and Security Consortium has launched the first of its many device security testing labs planned for 2017 as part of its… Read More

Devicemakers Call Nation-States Top Cybersecurity Threat

Devicemakers view government-sponsored hackers as the top cybersecurity threat, according to a new survey from KPMG. Read More