We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued ProTom International a Form 483 with eight observations following an inspection of the company’s manufacturing plant in North Reading, Mass., last December. Read More
The FDA’s Center for Devices and Radiological Health is proposing to issue an order requiring Philips Respironics to submit a plan to repair, replace or refund the purchase price of a range of recalled respiratory devices that it manufactured after November 2015. Read More
The FDA released a revised guidance clarifying when device sponsors that make certain low-risk product changes may not have to submit supplements for already approved premarket approvals (PMAs) or humanitarian device exemptions (HDEs) during the COVID-19 public health emergency. Read More
FDA investigators issued a four-observation Form 483 to Suture Concepts, a manufacturer of soft-tissue management devices, following a December inspection of the company’s Beverly, Mass., facility. Read More
Belgium-based Ion Beam Applications (IBA) has acquired Modus Medical Devices, a Canadian manufacturer of “phantoms” used for quality assurance in radiation therapy. Read More