MDoloris Medical Systems has secured regulatory clearance for its HFVI MOC-9 high frequency variability index monitor in Japan.

The HFVI MOC-9 technology is said to be the first monitoring solution for patients undergoing analgosedation and anaesthesia in Japan.

MDoloris has developed HFVI MOC-9 for incorporation into Masimo’s Root patient monitoring and connectivity hub to serve as a full brain monitoring system.

HFVI is a parameter derived from the Heart Rate Variability, which is similar as Analgesia Nociception Index (ANI) in Europe. ANI enables clinicians to evaluate the parasympathetic activity of patients undergoing surgery or intensive care in Japan.

MDoloris Medical System CEO and founder Fabien Pagniez said: “We are excited by this additional major milestone successfully passed by MDoloris in 2021 in Asia Pacific after the obtention of reimbursement and successful sales launch in South Korea, despite the pandemic impact.

“Thanks to the fantastic job performed with Heiwa Bussan, the exclusive business partner for both Masimo and MDoloris in Japan, we can look forward to a strong product launch and subsequent growth in one of the largest markets for our solutions.”

The company has also announced the upcoming launch of its ANI platform with medical devices import and sales company Heiwa Bussan in Japan.

ANI enables clinicians to evaluate the autonomic nervous system, helping them to titrate their analgesics during the surgery and anesthesia to improve postoperative pain, PONV scores, shivering scores, as well as reduce post-operative opioids use and hospital stays.

MDoloris Medical Systems, a venture-backed French company, offers continuous and non-invasive surgical stress monitoring devices to the clinicians across the world.