J&J Device Sales Fall
The healthcare giant reported worldwide medical devices sales of $27.5 billion for the full-year 2014, a decrease of 3.4 percent versus the prior year.
Trends to Watch For in Medical Device Industry
Access to recently developed materials, new technological deliveries and access to new markets are only a few of the trends that have affected changes in the medical device market and industry.
Behemoth Merger by End of the Month?
According to a regulatory filing dated January 12, Medtronic and Covidien could complete their $43 billion mega-merger by the end of the month.
Roche to Invest $1.18 B in Foundation Medicine to Boost Cancer Efforts
The deal will help Roche develop combination therapies and identify cancer patients more accurately.
Won’t Follow M&A Trend – Says Smith & Nephew CEO
Olivier Bohuon says he is not a fan of the concept of big is beautiful, and adds that there’s not much innovation occurring in hip implants.
The Key to Successfully Selling Medical Devices in China and Japan – Good Distributors
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
Humanitarian Use Devices and Third-Party Reimbursement
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?
Wake Up, Western Medical Device Makers!
While getting rid of the medical device tax is a key issue for many Western device manufacturers, perhaps a more important issue is global competition.
5 Questions About the Medical Device Tax, and Its Potential for Repeal
Will the device tax be repealed? What are its implications under the 114th Congress? This primer provides some answers.
HCT/P Regulation and Third-Party Reimbursement
Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.
