Insulet (NSDQ:PODD) said this week that it won ISO 27001 certification for its Omnipod Dash product, meeting the international standard for best practice in an information security management system. The Billerica, Mass.-based company’s Omnipod Dash system wirelessly connects Insulet’s Personal Diabetes Manager with a tubeless, waterproof insulin pump. The PDM calculates how much insulin should be administered using […]
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Dexcom inks $250m amended deal with Verily for next-gen diabetes tech
Dexcom (NSDQ:DXCM) said yesterday that it plans to pay $250 million upfront in stock to Verily in an amended collaboration and licensing deal. The two companies are working to develop a second-generation continuous glucose monitoring system. The updated deal also notes that the companies could collaborate on additional products and software. The new agreement structure makes […]
Boston Scientific puts $4B on the table for BTG’s interventional portfolio
Boston Scientific (NYSE:BSX) said today that it agreed to offer $4.24 billion to acquire British medical device maker BTG (LON:BTG) and its portfolio of interventional drug-device therapies. The Marlborough, Mass.-based company said that its acquisition of BTG will augment Boston Scientific’s capabilities in the treatment of cancer and pulmonary embolism. “We are confident that the addition of these therapies […]
FDA extends decision date for Sage’s postpartum depression injection
Sage Therapeutics (NSDQ:SAGE) said today that the FDA extended its decision date for Sage’s Zulresso brexanolone injection to March 19, 2019. The U.S. regulatory agency was previously slated to decide whether or not to approve the drug as a treatment for postpartum depression by Dec. 19. The Cambridge, Mass.-based company noted that the FDA elected to […]
Intersect ENT touts pooled analysis of steroid-releasing sinus implants
Intersect ENT (NSDQ:XENT) last week touted the publication of a pooled analysis of the company’s Propel Contour and Propel Mini steroid-eluting sinus implants. The company’s devices are designed to prop open the sinus ostia following endoscopic sinus surgery. As the implant dissolves, medicine is delivered directly to the sinus lining. The analysis, published in the International Forum […]
Valeritas prices $36m public offering
Valeritas (NSDQ:VLRX) today priced an underwritten public offering of 75 million shares at 48¢ per share and accompanying warrants. The Bridgewater, N.J.-based company expects to reel in roughly $36 million in proceeds from the offering. The offering’s series A and B warrants have exercise prices of 60¢ per share and 48¢ per share, respectively. Valeritas said the offering is […]
Lyndra touts positive results for long-acting drug-delivery tech
Lyndra Therapeutics reported positive results from a pharmacokinetics study of its once-weekly drug-delivery capsule, touting that it successfully transitioned a once-daily therapy to a weekly dosage form. The Watertown, Mass.-based company’s oral drug-delivery technique is designed to provide sustained release of one or more drugs for up to a week. Lyndra’s star-shaped capsule opens when […]
ivWatch inks distro deal for IV monitoring device
ivWatch said this week that it landed an international partner to manage the distribution of its continuous intravenous monitoring device. The Hampton, Va.-based company inked a deal with supplier New Medical to distribute its ivWatch Model 400 system in Australia and New Zealand. ivWatch’s sensor, which is roughly the size of a pencil eraser, uses light to […]
FDA warns on pain drugs for implantable pumps
The FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps. Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said. […]
Xeris Pharmaceuticals touts data for glucagon auto-injector
Xeris Pharmaceuticals (NSDQ:XERS) touted data this month for its ready-to-use glucagon auto-injector, highlighting the device’s efficacy and usability. The Chicago-based company’s rescue pen is under review for approval by the FDA as a treatment for severe hypoglycemia in people with diabetes. “Hypoglycemia can quickly evolve from a mild event to an emergency, so prompt and reliable intervention […]