Why 2019 U.S. Medical Device Market Is Expected to Exceed Last Year Revenues

PALM BEACH, Florida, March 21, 2019 /CNW/ - A recent article in a medical device industry periodical, INN, said that: "2018 has been an important year for the medical device industry as M&A, technology and regulatory catalysts have impacted the market.  Following these trends, 2019 is expected to be an even bigger year for the market. US Food and Drug Administration (FDA) fees, cybersecurity and the FDA's 510(k) submission are catalysts that could move the market next year."  Late last year, FORBES had described the medical device market as: "… A disruptive market of $410 billionuntil 2023… 

The INN report said that the faster path the FDA has promoted for approval of medical devises, will be a key reason for the market's continuing surge. It said: "In November, the FDA announced another update to its Medical Device Safety action plan. The agency said it is "pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology.  By doing this, the organization will "modernize" its 510(k) clearance pathway, which will affect medical devices.

The changes are meant to create a safer product for patients while holding companies accountable for any safety discrepancies, all while holding on to the FDA's "gold standard for safety."  Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Nevro Corp. (NYSE: NVRO),PAVmed Inc. (NASDAQ: PAVM), Motif Bio plc (NASDAQ: MTFB), Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX).

The agency intends to follow up with these goals in early 2019 by cementing an alternative 510(k) pathway. In the statement, the agency also says it believes this will promote greater transparency and post-market surveillance for medical devices. The FDA says this 510(k) upgrade pathway will also account for new advances in "material science" such as digital health, 3D printing and other technologies.