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The FDA has granted Grifols marketing clearance for its AlphaID At Home direct-to-consumer screening test for alpha-1 antitrypsin deficiency, which can cause a hereditary form of emphysyma as well as cirrhosis of the liver. Read More
Wintech Medipro, a manufacturer of surgical and medical face masks in Katy, Texas, has drawn a Form 483 for a host of observations, including inadequate complaint handling, medical device reporting and employee training. Read More
The device features a spectral sensor that continuously adjusts light intensity to compensate for higher light absorption levels in darker skin tones. Read More
Nuheara has gained FDA clearance for its HP Hearing Pro, meeting both FDA Class II and OTC requirements for hearing aids in a wireless ear bud design. Read More
Rockwell Medical received a Form 483 after the FDA observed inadequate corrective and preventive actions (CAPA) and equipment maintenance problems in a July inspection of the company’s Grapevine, Texas, facility. Read More
Thermo Fisher Scientific announced it will purchase The Binding Site Group, a UK-based developer of specialty assays and instruments for diagnosis and management of blood cancers and immune system disorders, for $2.6 billion. Read More
Massachusetts-based Abiomed’s Impella RP Flex with SmartAssist heart pump has received FDA’s premarket approval to provide temporary right ventricular support for up to 14 days. Read More