Intact Vascular said today that it won CE Mark approval in the European Union for its Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty below the knee. The indication extends the system’s use in the EU to the tibial arteries between the knee and the ankle. The Tack implant can be used in arteries ranging from […]
leon-nanodrugs, Bionpharma to develop microjet reactor-based dermatological product
leon-nanodrugs GmbH and Bionpharma Inc. said yesterday that the 2 groups inked a deal to develop a dermatological product using leon-nanodrugs’ microjet reactor nanotechnology platform. The companies will share the development of the undisclosed product. Development will be done at leon-nanodrugs’ U.S.-based formulation partner CoreRx in Clearwater, Florida. Bionpharma will market and distribute the product […]
Femasys Inc. raises $4m
Femasys Inc. said last week that it raised $4 million, according to a regulatory document filed with the SEC. Atlanta-based Femasys wrote that 8 investors contributed to the round and that it paid Los Angeles-based investment bank Salem Partners LLC an estimated $200,000 in sales commissions. The 1st sale in the financing round happened on Jan. 6 […]
Battery issue prompts recall for Physio-Control’s LifePak 1000 AED
Physio-Control said last week that it is launching a voluntary field action for its LifePak 1000 defibrillator, after reports that the device can shut down unexpectedly during treatment. The Redmond, Washington-based company has received 34 reports describing instances when customers have attempted to use the LifePak device and it has shut down due to an […]
FDA warns again on Pentax duodenoscopes
The FDA issued a statement today warning that Hoya (TYO:7741) subsidiary Pentax Medical’s ED-3490TK video duodenoscopes have a potential risk associated with the design and manufacturing of the device. Cracks in the adhesive that seals the scope’s distal cap and tip can lead to microbial and fluid ingress, according to information provided to the FDA by Pentax. […]
Eyewear giants Essilor, Luxottica to merge
Italian eyewear maker Luxottica (NYSE:LUX) and France’s leading lens manufacturer, Essilor (EPA:EI), have reached a €46 billion ($49 billion) agreement to merge and create a global eyewear company with annual revenue of more than €15 billion. “Finally … 2 products which are naturally complementary – namely frames and lenses – will be designed, manufactured and […]
Abbott touts dorsal root ganglion stim study
Abbott (NYSE:ABT) today touted short- and long-term data published in the journal Pain, which demonstrated that its dorsal root ganglion stimulation therapy benefits patients suffering from complex regional pain syndrome more than traditional spinal cord stimulation. The Abbott Park, Ill.-based company said it’s the only company in the world approved to offer DRG stimulation. The newly-published data […]
Bio-Rad Laboratories to acquire RainDance Technologies
Bio-Rad Laboratories (NYSE:BIO) said yesterday that it inked a definitive agreement to acquire RainDance Technologies for an undisclosed amount. The Hercules, Calif.-based company said it expects the transaction to close in the 1st quarter of 2017 and that it will reveal the terms of the acquisition when it discusses its 4th quarter and full-year financial […]
Medical isotope producer Shine Medical raises $27.2m
Shine Medical Technologies said last week in an SEC filing that it raised $27.2 million in a round of debt financing. Over 200 investors have contributed to the $29 million offering, which made its 1st sale on October 11, 2013. Monona, Wis.-based Shine Medical makes radioactive isotopes for medical diagnostic purposes such as detecting and treating cancer, according to the […]
Health Canada approves Fujifilm’s Vevo HD ultra-high-frequency ultrasound device
Fujifilm Sonosite Inc. subsidiary Fujifilm VisualSonics Inc. said today that it won approval from Health Canada for its Vevo Med ultra-high-frequency clinical ultrasound device. The device operates at frequencies that are higher than conventional ultrasound devices, enabling healthcare professionals to see sonograms with image resolution down to 30 micrometers. “Throughout its history, Fujifilm has been […]
Obalon logs 1st commercial use of weight loss balloon
Obalon Therapeutics (NSDQ:OBLN) said that it has begun U.S. commercial shipments of its Obalon weight-loss balloon. In September last year, Carlsbad, Calif.-based Obalon won pre-market approval from the FDA for its ingestible, gas-filled weight-loss balloon, with plans to have it on the U.S. market in early 2017. “It is incredibly gratifying to be shipping the Obalon balloon […]