LivaNova Receives FDA Clearance for its B-Capta System for the S5 Heart-Lung Machine (HLM)
On 20 April 2021, London-based LivaNova’s B-Capta, a novel, in-line, blood-gas monitoring system, received FDA clearance 510(k), to be integrated into the S5 HLM to effortlessly and accurately monitor the arterial and venous blood gas parameters even during long and complex pediatric and adult cardiopulmonary bypass procedures.
LivaNova announced that the B-Capta received CE mark approval in Europe in May 2020 and completed a limited commercial release in Europe. The device will now be available globally.
B-Capta system uses sensing technology to provide error-free and continuous measurements to allow the physicians to react to parameter changes quickly. Its interface aligns parameters to those of the hospital’s laboratory blood gas analyzers, reduces the set-up time, and includes accurate oxygen partial pressure measurements.
The company also announced the FDA 510(k) clearance for the S5 PRO HLM, an upgraded version of the heart-lung machine and which features B-Capta as a primary component alongside a new level sensor and improved software plus a new alarm system.
Jolly Good and Teijin Pharma Ties Up to Develop VR Digital Therapeutics for Depression
On 23 April 2021, Teijin Pharma Limited entered into a partnership with Jolly Good Inc. to develop a safe and effective cognitive-behavioural therapy virtual reality (CBT-VR) system for anti-depression therapy. The companies will jointly conduct clinical trials and seek regulatory approval in Japan.
The partnership will utilize Jolly Good’s VR technology and Teijin Pharma’s expertise in knowledge and strategic skills. The companies have also agreed to support healthcare workers as well as improve the quality of life of patients. This partnership is one of many steps Pharma/Biotech companies are taking to advance DTx in improving the mental health of patients.
BENEV Launches Sylfirm X Ultimate Edition in the U.S.
On 26 April 2021, BENEV Company Inc., an FDA-registered manufacturer, launched a novel RF micro-needling device, Sylfirm X, in the United States as the exclusive distributor. Sylfirm X is the world’s first and only FDA registered pulsed wave and continuous wave radiofrequency device and has added a new feature of 300-micron depth.
Sylfirm X Ultimate Edition is manufactured by Viol Co., Ltd (a Gyeonggi-do, South Korean-based company) and will be distributed by BENEV Company in the U.S. Sylfirm X claims eight different continuous and pulse wave bipolar RF delivery modes and uses bipolar non-insulated microneedle RF electrodes to uniformly treat the entire skin layer, maximizing treatment results and offering global skin improvements, mainly redness and vascularity with PW modes; and skin laxity with the CW modes. It is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Phoenix Cardiac Receives CE mark for Mitral Regurgitation Device
On 26 April 2021, Phoenix Cardiac Devices, Inc. received CE Mark for its BACE (Basal Annuloplasty of the Cardia Externally) device, which is a novel modality for the treatment of Functional Mitral Regurgitation (FMR).
BACE is the only surgical device approved with long-term clinical data signifying benefits by addressing the root cause of FMR.
With the CE mark, it is validated that the BACE device is a safe, less invasive, and cost-effective method for the potential treatment of functional mitral regurgitation. According to the company’s press release, this important milestone will give Phoenix Cardiac a fresh momentum to their efforts to secure a partner for a second clinical study of the BACE device as it pursues a potential indication for heart failure.
FDA Green-Light to Lumenis for its IPL Device to manage Dry Eye Disease
On 29 April 2021, FDA granted De Novo authorization to Lumenis Ltd., the world’s largest energy-based medical device company for ophthalmic, aesthetic, and surgical applications and the inventor of intense pulsed light (IPL) technology, for its newest IPL device for improving signs of dry eye disease due to Meibomian Gland Dysfunction (MGD). It is the first and only such device to receive FDA approval for improving signs of dry eye disease.
The company has also launched OptiLight, a bright solution for dry eyes. OptiLight™ with Lumenis’ patented OPT® technology is designed for a consistent, precise, and controlled light-based treatment of signs of dry eye disease.
FDA Approval to Medtronic for Testing Implantable Tibial Neuromodulation Therapy for Bladder Incontinence
On 29 April 2021, Medtronic received approval from the FDA to advance with an investigational device exemption (IDE) trial to estimate its internally developed implantable tibial neuromodulation (TNM) device. It is a therapy designed to offer relief from symptoms of bladder incontinence.
The company will conduct the TITAN 1 Feasibility Study, a prospective, multicenter feasibility study to characterize the procedure for the implantable TNM device in subjects with bladder incontinence. Around twenty patients from eight sites in the U.S. will receive a device and will be followed for 12 months. Enrollment in the clinical study is expected to begin in May 2021.
