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Food and Drug Administration (FDA)

The Boston Scientific Vercise Gevia

Hand-out Boston Scientific Corporation

The Food and Drug Administration (FDA) has approved Boston Scientific’s ImageReady MRI labelling for the Vercise Gevia Deep Brain Stimulation (DBS) system to be used in a full-body environment. Read more

North America

Biomedical startup Adapttech has seen its technology for improving the fitting of lower limb prostheses receive approval from the Food and Drug Administration as a Class I medical device. Read more

News

Dassault Systèmes has extended its collaboration with the U.S. Food and Drug Administration for another five years. Read more

News

Web content editor Ian Bolland spoke to Morgan Palmer, chief technology officer and Kim Wakeman, solutions engineer at ETQ about the FDA’s decision to formally end the Alternative Summary Reporting (ASR) Program. Read more

North America

Medtronic is recalling 11 versions of its MiniMed insulin pumps amid fears of cybersecurity risks. Read more

News

Johnson & Johnson Medical Devices Companies has announced that Ethicon has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VistaSeal open and laparoscopic Dual Applicators, to address surgical bleeding Read more

North America

The Food and Drug Administration has approved Boston Scientific’s Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease. Read more

North America

CSA Medical has announced its RejuvenAir System has been designated as a breakthrough device by the U.S. Food and Drug Administration (FDA). Read more

North America

BD has responded to warnings from the FDA surrounding risks from drug-coated devices by trying to reassure customers and shareholders. Read more

Devices

The Food and Drug Administration (FDA) has said that more work needs to be done when it comes to further enhancing patient safety regarding materials used in medical devices and implants. Read more

North America

The Food and Drug Administration commissioner Scott Gottlieb has tendered his resignation, meaning he will leave his post next month. Read more

North America

The Food and Drug Administration (FDA) has revealed it has received an increase in reports of breast implants linked to a deadly cancer. Read more

North America

Regular contributor Reece Armstrong looks for the positive repercussions in what turned out to be a challenging past year for the medical device sector. Read more

Opinion

The Advanced Medical Technology Association (AdvaMed) has proposed legislation to continue medical device reviews from the Food and Drug Administration (FDA) in the event of U.S. government shutdowns. Read more

North America

Orthopaedic fixation company Ossio has received 510(k) market clearance from the Food and Drug Administration (FDA) for its OSSIOfiber Bone Pin Family. Read more

North America

The Food and Drug Administration has announced it is finalising guidance on its existing Breakthrough Devices Program as well as announcing plans for a Safer Technologies Program (STeP). Read more

North America

Eight medical device firms have been selected by the Food and Drug Administration (FDA) to help prevent and treat opioid use disorder. Read more

North America

The Food and Drug Administration (FDA) has granted Breakthrough Device Designation to artificial intelligence software for chronic thromboembolic pulmonary hypertension (CTEPH) pattern recognition. Read more

North America

The Food and Drug Administration (FDA) has announced “several key actions” to update its Medical Device Safety Action Plan with the aim of creating a more robust medical device safety net through better data. Read more

News

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Homeland Security (DHS) have entered a partnership to help address cybersecurity in medical devices. Read more

Devices