Topic:

Regulatory

Latest Headlines

Latest Headlines

U.S. DOJ probes Olympus over kickbacks, false marketing claims

The U.S. Department of Justice is investigating allegations that Olympus representatives may have violated a pair of federal laws governing kickbacks and false claims in marketing its medical devices, the Japan-based company said.

Drugmakers fall in line with Pakistani government's price-cutting plans

SINGAPORE-- Pakistan's pharmaceutical industry reportedly has decided to step aside and cease opposition to a government plan to force down the price of certain drugs marketed in the country as of July 1, 2016.

Pet tear-stain removers still widely available despite FDA warnings

The extreme cold gripping the country is likely causing a lot of watery eyes, not just in people, but in dogs, too. In some breeds, excess tearing can result in brownish stains under the eye--a common condition that has prompted several companies to market products meant to erase those marks.

FDA approves the first 3-D breast CT scanner without tissue compression from Koning

Koning has gained a PMA approval for the first 3-D breast computed tomography scanner to extensively image the breast without compressing it.

CMS finalizes plan to offer Medicare coverage for CT scans among smokers

In an effort to detect lung cancer, the Centers for Medicare & Medicaid Services finalized plans to offer Medicare coverage for CT scans, or low-dose computed tomography, among smokers aged 55-77.

U.S. Chamber knocks IP laggards India, Indonesia, Thailand and Vietnam in Asia

SINGAPORE-- India, Indonesia, Thailand and Vietnam are at the bottom in terms of protections for intellectual property, and much of the rest of Asia is ranked near them in an assessment by a U.S. Chamber of Commerce unit. Singapore was ranked in the top 5 in the Pacific region with Australia, Japan, New Zealand and South Korea close behind.

FDA Commissioner Margaret Hamburg to step down

After 6 years at the helm of the FDA, Commissioner Margaret Hamburg is preparing to step down. Her legacy will be a positive one in the device world, where relations between the regulator and industry are much better than when she came into office.

Medtronic gains first FDA approval for Covidien device: Pipeline Flex for brain aneurysm

Medtronic scored its first new FDA approval resulting from the acquisition of Covidien, which closed less than two weeks ago. The nod is for Pipeline Flex, a next-generation minimally invasive flow diversion device for unruptured aneurysm. It comes from Covidien's fast-growing, but tiny, neurovascular group.

FDA chief Hamburg to step down, with new deputy a potential successor

Dr. Margaret Hamburg is stepping down from her post as FDA commissioner sometime in March after 6 years of serving in the position, according to government officials.

DOJ issues permanent injunction against German devicemaker for violating FDA regs

After conducting 10 inspections and overseeing 45 recalls on devices made by Germany's Maquet Holding, and repeatedly citing it for violations of the Quality System good manufacturing, Medical Device Reporting and other regulations, the FDA has had enough.