Approvals

FDA Clears ‘Industry-First’ Mammography Device

GE Healthcare received 510(k) clearance for its “industry-first” mammography remote control device called Senographe Pristina Dueta.

Patients can use the handheld wireless remote control to manage their compression during examinations with GE’s mammography system.

FDA Approves Biotronik’s Quadripolar CRT Pacemaker

Biotronik secured FDA approval for its Edora HF-T QP MR conditional quadripolar cardiac resynchronization therapy pacemaker (CRT-P).

The device allows physicians to tell the implant an MRI exam is coming up, so the device can automatically engage its MRI safety mode during a scan.

FDA Clears XSTAT to Stop Gun and Knife Wounds in Arms and Legs

RevMedX secured FDA 510(k) clearance for XSTAT 12 and XSTAT 30 devices used to stop severe bleeding from knife and gun-shot wounds in the arms or legs.

The devices are large syringes that quickly push dozens of tablet-sized highly absorbent pieces of foam into a wound. Once the foam tablets are inside the wound, they quickly expand, blocking the blood from escaping and delivering pressure onto the wound from within.

The FDA previously approved the devices for use in civilian and battlefield situations, but only to treat junctional wounds around the groin and shoulders.