FDA approval—r-SNM system (Axonics)
Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted.
FDA 510 (k) clearance—Critical Care Suite (GE Healthcare)
GE Healthcare has received FDA 510(k) clearance of its Critical Care Suite, which a press release reports are an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcare’s Edison platform, the AI algorithms are designed to reduce the turn-around time it can take for radiologists to review a suspected pneumothorax.
FDA 510 (k) clearance—ACR test (Healthy.io)
Healthy.io has received 510(k) clearance from the FDA for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease. A press release reports that this is the second FDA clearance the company has received. Additionally, the company also closed a $60 million Series C funding round led by Corner Ventures with participation by Joy Capital and all previous investors: Ansonia Holdings, Aleph, and Samsung NEXT.
FDA Breakthrough Device Designation—Checkpoint BEST system (Checkpoint)
Checkpoint Surgical has received FDA Breakthrough Device Designation for the Checkpoint brief electrostimulation therapy (BEST) system. The Checkpoint BEST system is, a press release reports, designed to provide electrical stimulation of peripheral nerves to promote nerve regeneration as an adjunct to surgical intervention following nerve injury, with the goal of accelerating and improving patient recovery.
FDA Breakthrough Device Designation—V-Wave
V-Wave has announced that FDA has granted it a second Breakthrough Device Designation—the first was for its interatrial shunt for heart failure and the second is for pulmonary arterial hypertension. The company is testing a minimally invasive, implanted interatrial shunt device for pulmonary artery hypertension in a global approved investigational device exemption (IDE) early feasibility study (RELIEVE-PAH).
FDA Breakthrough Device Designation—WiSE (EBR Systems)
EBR Systems has announced that the FDA has granted Breakthrough Device Designation for its WiSE cardiac resynchronisation therapy (CRT) for the treatment of heart failure. The WiSE (wireless stimulation endocardially) CRT system is designed to improve the heart’s pumping ability by synchronising the left and right ventricles to distribute blood to the lungs and body more effectively.
