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The European Commission has issued a regulation that will allow devicemakers to distribute instructions for use (IFUs) in electronic format, playing catch-up with the FDA and other international regulatory agencies that have already allowed devices to be accompanied by electronic-only instead of paper instructions. Read More
Allergan Aesthetics, an AbbVie company, has completed its $550 million acquisition of Irvine, Calif.-based Soliton, gaining that company’s rapid acoustic pulse device for improving the appearance of cellulite. Read More
Sponsors of devices already cleared through the FDA’s 510(k) pathway that wish to gain approval for changing the sterilization method they use may find it easier to do so under a new pilot program the agency is considering. Read More
The review was triggered by Philips’ international recall of its ventilators, CPAP and BiPAP devices due to risks posed by the soundproofing material. Read More
The company is sponsoring clinical research on the system in three study programs worldwide, including an early feasibility study in the U.S. Read More
Dental Technologies of Lincolnwood, Ill., drew an FDA warning letter for not adequately investigating a manufacturing problem, among other quality violations. Read More
Sponsors of device trials in the EU that need to make significant changes to their study protocols can consult a new guidance document just released by the European Commission’s Medical Devices Coordination Group (MDCG) — written to support procedures for device trials as they relate to the EU’s Medical Device Regulation. Read More