Emergo by UL The U.S. Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance. Once finalized, the guidance document updates would expand the Breakthrough Devices Program’s scope to include devices that will improve accessibility and promote health equity. Specifically, the draft guidance clarifies the considerations […]
FDA sets steep increases for 2023 medical device user fees
Emergo by UL Medical device manufacturers and importers seeking to sell their products in the U.S. market can expect substantial increases in some FDA fees compared with those for 2022. The fee increases take effect at the beginning of FDA’s 2023 fiscal year, which began October 1, 2022. Notably, FDA is switching to a five-year […]
MassDevice.com +3 | The top 3 medtech stories for May 28, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Creating a compliant, lock-tight site budget for clinical trials
By Kathi Shah, MS, MBA
Creating a clinical trial site budget sounds simple right? A Sponsor contracts with an investigative site to conduct a clinical trial per the protocol. The Investigative site is compensated by the Sponsor to conduct the services outlined in the protocol. The relationship between the Sponsor and Investigative site is heavily weighted on the budget developed to compensate sites for their efforts to conduct the study.
Becton Dickinson mulls surgical instruments unit sale
(Reuters) — Medical equipment supplier Becton Dickinson & Co. (NYSE:BDX) is exploring a sale of its V. Mueller surgical instruments business following its $12 billion acquisition of peer CareFusion, according to people familiar with the matter. Franklin Lakes, N.J.-based BD hired investment bank JPMorgan Chase & Co. to assist with a potential sale, which could fetch […]
China jacks up registration fees for medical devices, drugs
(Reuters) — The China Food & Drug Administration steeply raised the fees required to register medical devices and drugs in the world’s 2nd-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.
Interoperability and the trough of disillusionment
Report: FBI probes what J&J knew about uterine surgery device
MassDevice.com +3 | The top 3 medtech stories for May 27, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
China investigates former top health official
(Reuters) — China is investigating the former head of a healthcare ministry unit responsible for drug trials and leading implementation of healthcare policy for bribery, a prosecutor said yesterday.
A court in Sichuan province said it was investigating Wang Yu, the former top official at the Bureau of Medical Administration, as part of a crackdown on corruption in the healthcare sector.
ConMed ripe for M&A | The week in medtech M&A
Analyst: ConMed ripe for M&A spree May 19, 2015 by Fink Densford ConMed, in the middle of an under-appreciated turnaround, could be poised to augment its growth via selective acquisitions, according to Leerink Partners analyst Richard Newitter. Newitter, who upgraded CNMD shares to “outperform” and boosted the price target to $64 from $60, wrote in […]
