Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
Levita Magnetics International Corp. received uplifting news this week as the U.S. FDA cleared its magnetic-Assisted Robotic Surgery (MARS) minimally invasive surgical platform. MARS builds on the company’s first product, the Levita magnetic surgical system, by providing greater control of surgical instruments to surgeons. The platform is cleared for use in bariatric, colorectal, gallbladder and prostate surgeries.
Mdoloris Medical Systems SAS reported it has developed an automated system for regulating perioperative pain based on continuous optimization of parasympathetic tone. Closed-loop control systems are still rare in the anesthesia space, but they provide greater reliability in achieving set objectives, reduce the risk of human error and free the anesthesiologist from the burden of manually adapting the administration of the various therapies required for surgery.
Cresilon Inc. obtained U.S. FDA clearance for a hemostatic gel that staunches the flow of blood from minor external wounds. The Cresilon hemostatic gel (CHG) is the first technology to blend polymers from the algae plant to instantaneously create a mechanical barrier against bleeding.
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
Surgical care startup Medivis Inc. tallied $20 million in a series A financing led by Thrive Capital. The funds will be used to advance its 3D holographic clinical visualization system. Initialized Capital and Mayo Clinic also participated in the round, along with investors Bob Iger, Kevin Durant, Robert Spetzler, Hugo Barra and Coalition Operators. With the funding from the series A, Medivis has raised a total of roughly $25 million to date.
A surgical navigation platform developed by Proprio Inc., that is intended to replace traditional surgical technologies which produce harmful radiation and can impede surgical workflow, won U.S. FDA 510 (k) clearance.
Beijing Surgerii Technology Co. Ltd. completed a series C3 round to support the development of its robotic system for single-port laparoscopic surgery.
The U.S. FDA has cleared Aroa Biosurgery Ltd.’s 510(k) for its Enivo pump and catheter, which are key components of the company’s new Enivo tissue apposition platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in removing surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
