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Two device companies that share the same address in Natick, Mass., have received separate warning letters from the FDA for quality system failures observed during an FDA inspection, including not fully investigating complaints and a lack of adequate corrective and preventive actions (CAPA). Read More
The initial response to the FDA’s trial opening of its Customer Collaboration Portal to premarket device submissions has been encouraging, the agency says. Read More
It’s possible to detect the potentially stroke-inducing cardiac condition atrial fibrillation effectively and more cheaply using wearable devices, according to researchers at Harvard Medical School and Massachusetts General Hospital. Read More
Cognito Therapeutics’ gamma sensory stimulation therapy reduced white matter atrophy in the brains of patients with Alzheimer’s disease in a six-month study, the company announced at the Alzheimer’s Association International Conference 2022 in San Diego. Read More
Janet Woodcock, principal deputy FDA commissioner, made clear the dire situation her agency will be in if user fees aren’t rapidly reauthorized and the FDA doesn’t receive new money from Congress to update its flagging IT infrastructure. Read More
As the EU’s 2017 Medical Device Regulation (MDR) comes fully into force, devicemakers need to keep track of significant changes in the form of “implementing and delegated acts,” according to one UK-based regulatory expert. Read More
Smiths Medical has issued an urgent medical device correction letter about a potential risk associated with pressure chambers used with the company’s Level 1 Fast Flow Fluid Warmers, which deliver solutions or warmed blood to patients. Read More
The Center for Devices and Radiological Health (CDRH) is seeking companies involved in medical device development and manufacturing to participate in its Experiential Learning Program (ELP), which sends CDRH staff on virtual or on-site training visits. Read More
Lice Clinics of America says its medical device is the only product on the market that has been cleared by the FDA to use air in treating head lice. Read More
Boston Scientific has agreed to pay $85 million to Nevro to settle their intellectual property litigation over spinal cord stimulation patents. Read More
The FDA has pledged to help manufacturers of sterilized devices if a new emissions regulation planned by the Environmental Protection Agency (EPA) for later this year causes disruption in commercial sterilizer facility operations. Read More