Companion Spine Announces FDA Premarket Approval ("PMA") of the DIAM™ Spinal Stabilization System for the Treatment of Degenerative Disc Disease ("DDD")

Companion Spine, the French-American specialist in surgeon innovated spine implant surgery, announced that the U.S. Food and Drug Administration (the "FDA") has approved the DIAM™ Spinal Stabilization ...
Becker's Spine Review

Companion Spine’s posterior motion-preserving device earns premarket approval

Companion Spine earned the FDA’s premarket approval for its DIAM spinal stabilization system, according to a Dec. 15 news release. DIAM is the first posterior motion-preserving device approved in the ...
Business Wire

Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for Evolysse™ Sculpt Injectable Hyaluronic Acid Gel Product

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that it has ...
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Femasys gets FDA OK for final FemBloc trial, secures $12M financing, stock surges

Femasys (FEMY) on Monday said that the FDA approved continuation of the final phase of its FemBloc pivotal trial, sending shares 25% higher in premarket trading. This milestone follows the successful ...
Law

FDA Sued Over Allegedly Defective Spinal Cord Stimulators

The suits cite the U.S. Supreme Court’s 2024 decision in Loper Bright Enterprises v. Rainmondo in naming the FDA as a defendant. The lawsuits allege the devices should require pre-market approval ...
Crypto Briefing

Gemini stock soars premarket after US prediction markets license approval

Gemini derivatives approval boosts shares as CFTC grants a license for Gemini to operate a US derivatives exchange and ...

Companion Spine Announces FDA Premarket Approval ("PMA") of the DIAM Spinal Stabilization System for the Treatment of Degenerative Disc Disease ("DDD")

DIAM Spinal Stabilization System is the first posterior motion-preserving device approved in the U.S. for the treatment of moderate to severe primary low back pain A breakthrough treatment addressing ...