March 3, 2017

European Council to vote March 7 on MDR

The European Council is set to vote March 7 on the recently finalized EU Medical Device Regulation (MDR), which requires more labeling data for devices, as well as consistency between labels and information found elsewhere in print and online.

After the March 7, vote, the European Parliament will vote on March 20. If passed, the regulations could become effective as early as May. Manufacturers would then have three years to comply with the MDR and five years to comply with the IVDR.

Japan’s PMDA Approves HAL for Medical Use

Japan’s Pharmaceuticals and Medical Devices Agency approved Cyberdyne’s HAL, a device that helps the movement of lower limbs during gait training therapy.

PMDA said non-clinical data on electrical safety, electromagnetic compatibility, and performance of HAL indicated no problems. Clinical testing showed the therapy increased walking distance by about 10 percent.

New Zealand Finalizes Agreement to Use Smith and Nephew Implants

New Zealand’s medical device and drug regulator has finalized an agreement to let the country’s hospitals purchase about 4,200 orthopedic implants and associated products from Smith and Nephew.

The final agreement would allow Smith and Nephew to supply the products at negotiated prices starting April 1. The original starting date in the proposed agreement was March 1, but the Pharmaceutical Management Agency extended the date to resolve inaccuracies in the schedule of prices (IDDM, Feb. 3).

FDA Grants Approval to Intersect ENT’s Steroid Releasing Implant Device

California–based, Intersect ENT has received FDA approval for Propel Contour, a dissolvable, steroid-releasing implant device that facilitates treatment of patients with chronic sinusitis in the frontal and maxillary sinuses.

The device is designed to conform to the sinus ostia, has a flexible delivery system to make it easier to access tight areas and deliver the steroid where it’s needed.

FDA Clears Expanded Indication For Vidas Brahms PCT Assay

The FDA has cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, and stopped in patients with sepsis.

The test is intended to be used in the hospital or emergency room.

FDA Permits Marketing Of Phenotest BC Kit for Bloodstream Infections

The FDA has allowed the marketing of the PhenoTest BC Kit to identify organisms that cause bloodstream infections and provide information about which antibiotics the organism is likely to respond to.

The test can identify 14 different species of bacteria and two species of yeast that cause bloodstream infections, while also providing antibiotic sensitivity information on 18 selected antibiotics.