‘Invisible scalpel’ wins CE Mark for Guided Therapy Systems

Guided Therapy Systems has launched its intense therapeutic ultrasound (ITU) Actisound device in the U.K. and Europe following CE Mark approval. Actisound acts like an invisible scalpel, working beneath the surface of the skin to precisely deliver small thermal ablations to tendons, ligaments, and other soft tissue to stimulate collagen growth and the regeneration of connective

ARTMS’ system may ease cost, shortage of valuable radioisotopes

ARTMS Products (Vancouver, B.C) has won the CE mark for its first-in-class, advanced technology Quantm irradiation system, designed to produce high-value medical imaging isotopes such as technetium-99m (Tc-99m) on medical cyclotrons. Tc-99m is given to nearly 50,000 Americans every day to diagnose cancer and heart disease. It is used in more than 80% of all nuclear

Integer adds radial introducer for patients with smaller arteries

Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark. RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division.

Regulatory changes a top concern for medtech companies in 2018

Changing regulatory environments are a top concern for medtech industry professionals in 2018, according to a recent survey from Emergo Group (Austin, Texas). According to the survey, 68% of industry senior managers and executives said that changing regulatory environments is one of the biggest challenges their companies face. Europe is currently going through major regulatory

Why U.S. first may be the new medical device development strategy

Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice