Strata Skin Sciences (NSDQ:SSKN) said it has reached an agreement with an “internationally acclaimed health institution” giving Strata an exclusive license to treat vitiligo using its Xtrac excimer laser. In a novel treatment for vitiligo, the excimer laser incrementally increases the light emitted in the UVB range to restore pigmentation to skin areas affected with […]
In2Bones intros ‘see-through’ implant for flat feet
Orthopedic surgical device developer In2Bones announced the global launch of its “see-through” PitStop implant for children and adults with flat feet. One of the most common foot deformities, flat-foot often starts during adolescence and continues into adulthood. In2Bones (Memphis, Tenn.) developed the PitStop subtalar implant to restore the stability of a patient’s arch during the walking […]
Enhancing post-market safety
Ashton Steinhagen, lead clinical research associate for IMARC Research, Inc. The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018. The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and […]
Olympus fined $85 million in duodenoscope case; former exec faces prison
Olympus (TYO:7733) and a former senior executive in Japan have pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the devices in the United States despite those failures, the Justice Department announced. Tokyo-based Olympus and Hisao Yabe, 62, both entered guilty pleas before […]
OrthoPediatrics announces pricing of common stock offering
OrthoPediatrics (NSDQ:KIDS) said today it will price an underwritten follow-on public offering of 1.5 million shares of its common stock at $27 per share. The company said it plans to use the proceeds of offering to invest in implant and instrument sets for consignment to its customers, fund research and development activities, expand its sales and […]
Meril Life Sciences wins approval for TAVR in India
Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells […]
Bruin Biometrics lands second SBIR award for ortho device
Bruin Biometrics (BBI) said it has won a $1.4 million Small Business Innovation Research (SBIR) Phase II program award from The National Institute of Arthritis and the musculoskeletal and skin division of the National Institutes of Health. BBI (Los Angeles) uses biometric sensor technology to aid clinicians in the early detection and monitoring of chronic, […]
MiMedx to lay off 24% of workforce in restructuring effort
MiMedx (NSDQ:MDXG) said yesterday that it plans to eliminate 24% of its total workforce as part of a larger overall plan to reduce cost and improve efficiency. The Marietta, Ga.-based company said that it plans to eliminate 240 full-time employees, with approximately half of those cuts coming from the salesforce. The plan also includes reducing costs […]
Vapotherm touts automated oxygen controller in preemie study
A recent clinical trial showed that Vapotherm’s (NYSE: VAPO) new IntellO2 module for its Precision Flow system greatly improved the chances of keeping premature babies in the target oxygenation range. The prospective, multi-center, controlled, order-randomized crossover trial demonstrated that using the IntellO2 module helped clinicians maintain newborns in the physician-prescribed oxygen saturation range 80% of the time, compared with 49 % […]
Notal Vision snags breakthrough designation for home OCT system
Ophthalmic diagnostic services company Notal Vision said it has won breakthrough device designation for its artificial-intelligence-aided macular degeneration diagnostic device. Privately-held Notal (Manassas, Va.) said its home-based optical coherence tomography (OCT) system was designed to automatically identify intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD). The Notal Home […]
Inspire Medical offers another 1.5 million shares following April IPO
Inspire Medical Systems (NYSE: INSP) is offering 1.5 million shares of common stock for sale to the public, and its stockholders are selling 1 million additional shares of the stock, according to a regulatory filing. The company hopes to make $66.8 million on the sale. Maple Grove, Minn.-based Inspire, which spun out from Medtronic (NYSE:MDT) in 2007, makes devices […]
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