News of Note—CDRH sent one warning letter to devicemakers this year

News of note

> In a sharp drop from the 18 warning letters it sent by July 2016, the FDA’s Center for Devices and Radiological Health issued a single warning letter this year—to St. Jude Medical about its implantable cardiac devices. Bloomberg story

> ExThera earned the FDA’s Expedited Access Pathway designation for its Seraph blood filter, a device designed to remove pathogens from whole blood. Release

> The FDA cleared Smiths Medical’s wireless, ambulatory infusion pump. Release

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

Suggested Articles

The FDA has cleared Drawbridge Health’s blood collection device designed to help monitor long-term blood sugar levels in people with diabetes.

FierceMedTech Fierce 15 winner 10x Genomics announced its plans for a $100 million IPO, on the Nasdaq using the symbol TXG.

Belgian devicemaker Miracor Medical received a breakthrough designation from the FDA for its treatment designed to limit the damage of a heart attack.