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1. FDA clears Joimax Endovapor 2
Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates electricity for monopoly and bipolar cutting and coagulation of tissue structures in surgery. It has programs designed for spinal cord surgery with an interdisciplinary application. It also has 2 monopolar and 2 bipolar sockets with an easy touchpad technology.
2. Health Canada approves Eclipse MicroPen Elite
Eclipse Aesthetics announced that it has received clearance from Health Canada for the Eclipse MicroPen Elite advanced micro-needling device, according to an April 26 press release. The MicroPen Elite is an advanced medical-grade, automated, cordless, high-speed micro-needling device that is designed to improve the appearance of wrinkles, stretch marks, acne scars, skin tone and texture. It can be used on the face, neck, décolleté, arms, hands and more. The MicroPen Elite is a safe alternative to common skin resurfacing tools like lasers and dermal rollers.
3. Theraclion inks Chinese joint venture
Theraclion announced in an April 24 press release that it has signed a joint venture agreement with Inner Mongolia Furui Medical Science Co. Theraclion will own 56% of Theraclion China Co. and 44% of Inner Mongolia Furui Medical Science Co. The joint venture company will be based in Shenzhen, China and will develop the Chinese market for Theraclion’s Echopulse.
4. Mederi Therapeutics wins SAGE CSR support for GERD treatment
The Society of American Gastrointestinal and EndoScopic Surgeons (SAGES) recently issues a Clinical Spotlight Review (CSR) Guideline statement on Stretta Therapy for GERD for Mederi Therapeutics, according to an April 24 press release. The CSR recommendation suggests that Stretta significantly improves health-related quality of life score, heartburn scores, and incidence of esophagitis and esophageal acid exposure in GERD patients.
5. Millennium Medical Technologies wins FDA nod for Lipo-Loop
Millennium Medical announced in an April 24 press release that it has become the first in the nation to receive FDA clearance for a reusable fat collection and transfer system that is used in plastic or reconstructive surgery and regenerative aesthetics. Additionally, the clearance covers the use of components used with the company’s liposuction and body shaping technology. The suction canisters in the Lipo-Loop system are molded from medical-grade materials and come in sizes of 250, 500, 1,000, 2,000 and 3,000 ml. They are also packaged non-sterile but are autoclavable. Collection jars have a stainless steel Luer fitting at its base to facilitate the transfer of untreated fat back into the patient by a cleared injection apparatus.
6. Anaconda Biomed taps Creganna Medical for device dev
Anaconda Biomed announced that it has chosen Creganna Medical to develop, test and manufacture its ANCD BRAIN device, according to an April 24 press release. The product is currently aiming to go through regulatory and clinical phases. Creganna Medical will support Anaconda Biomed in the final stages of its product development from manufacturing to obtaining CE approval in Europe.
7. SiBone logs U.K. guidelines win
SiBone announced in an April 7 press release that the U.K.’s National Institute for Health and Care Excellence has published its Interventional Procedure Guidance document for minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. MIS SI joint fusion should be available to patients who are diagnosed in the U.K. National Health System, according to the guidance. It also suggested that the safety and efficacy of minimally invasive sacroiliac joint fusion surgery sufficient as long as there are standard arrangements.
