US OKs American Medical's prolapse repair technology:
This article was originally published in Clinica
The US FDA has given American Medical Systems the all-clear to sell its minimally invasive technology for repairing vaginal prolapse. The Apogee system, which repairs vaginal vault prolapse using graft material, is designed to improve patient outcomes compared with traditional abdominal or laparoscopic techniques, said the Minnetonka, Minnesota company. Scheduled for commercial release later this year, it will join the firm's other prolapse product, the Straight-In Sacral Colpopexy system. Over 36 million women in the US and Europe suffer from vaginal prolapse, with over six million of those cases being severe, the firm added. Because current procedures are lengthy and complex, only 350,000 surgical repairs are performed annually.
You may also be interested in...
BD and BioMedomics have released a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.
A medtech industry group is asking the Trump administration to clarify if small medical device companies that have equity investors qualify for small business loans and forgiveness under the coronavirus relief package.
Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.