MHRA Cautions on Needle Breakage
The UK’s Medicines and Healthcare products Regulatory Agency is advising that those using steel cannula infusion sets manufactured by Unomedical to check them before and after use. The agency says there is a small risk that the needle could break, resulting in the leakage of medication. Found in clinical and home settings, the infusion sets are used to treat diabetes, Parkinson’s disease and chronic pain. According to an MHRA announcement, the following steel cannula infusion sets are affected: SURE-T, SURE-T Paradigm, Contact Detach, Contact, Sub Q, Neria, Neria Detach, Neria Multi and Thalaset.
EMBA Medical Scores CE Mark Hourglass
Dublin, Ireland-based EMBA Medical has received the go-ahead from EU authorities to market the Hourglass peripheral embolization plug. “This is the first integrated, over-the-wire device designed for peripheral embolization procedures,” says EMBA CEO George Wallace, in a prepared statement. “The goal with over-the-wire design is to provide physicians with an accurate, stent-like delivery of the device in the vessel.” The device is not approved for sale in the U.S.
FDA Blesses ReShape System
Obese patients in the U.S. soon will have a new noninvasive treatment option. The FDA has signed off on an integrated dual balloon system from San Clemente, Calif.-based ReShape Medical. The device is delivered into the stomach through a minimally invasive endoscopic procedure that can be completed in 30 minutes or less. The temporary device should be removed six months after insertion. It is indicated for weight reduction in obese adult patients with one or more obesity-related condition and who have failed previous attempts at weight loss through diet and exercise alone.
Details Emerge about J&J/Google JV
Indian competition authorities have given their blessing to a joint venture between Johnson & Johnson’s Ethicon unit and Google to advance the development of robotically assisted surgical devices. Dubbed Warren Robotics, the collaboration first was announced in March. At the time, neither the name of the JV nor the financial details were disclosed. The Indian authorities determined that because the assets being contributed were entirely outside the country and there were no horizontal or vertical overlaps, there would be no adverse effects on competition.
MeMed Gets Grant from EU Initiative
Israel’s MeMed has scored a $3.3 million grant from the European Commission to support the development of its Respiratory ImmunoDx project. Provided by the commission’s Horizon 2020 Small and Medium-Sized Enterprise Instrument initiative, the grant gives funding for products that potentially could affect the EU economy and global healthcare. MeMed will use the money to ensure the second-generation ImmunoDx can take measurements of a patient’s immune response to infection at the point of care, and to fund a multicenter study evaluating the device for patients with lower respiratory tract infection.