The agriculture sector is still in serious talks on what items should require genetically modified organism labeling, the definition of GMO, the kinds of labels to be used and the products that can be exempted from the labeling. Consumers, food manufacturers and retailers all want the ruling to be simple, clear and cover all biotech products.
Biofuels and oil industries testified at the Environmental Protection Agency's public hearing on the proposed blending volumes for 2019 and 2020 under the Renewable Fuel Standard, in which the industry, including the American Coalition for Ethanol, tackled issues such as the agency's overall approach to enforcing the RFS, conventional biofuels levels and the effective working of the renewable identification number marketplace. The Renewable Fuels Association said that the agency should take action to reallocate 2.25 billion ethanol-equivalent gallons to oil refiners and that the EPA must ensure that small refinery waivers are not abused or granted unnecessarily.
Abbott is making big investments in production capacity for its FreeStyle Libre continuous glucose monitor, as it expects the product to generate $90 million or more this year, CEO Miles White says. White says the company's $470 million diabetes care unit saw 34% quarterly organic growth.
A round of financing has been closed by Viz.ai, generating $21 million in proceeds for expansion of the company's development and sales teams and for US clinical trials. The company has developed a diagnostic algorithm that analyzes CT scans using artificial intelligence for faster diagnosis and treatment of stroke.
A round of equity financing involving eight anonymous sources has pulled in $2 million for Louisville, Ky.-based Neuronetrix, which develops tools for evaluating cognitive disorders. The company has not disclosed how it intends to use the proceeds.
Additional growth capital has been secured by Seattle-based Bardy Diagnostics from its existing equity investors. The company, which develops ambulatory cardiac monitors and custom data technologies, will use the financing for expansion of its monitoring services and sales team, as well as to advance research and development and artificial intelligence diagnostics.
A 107-patient clinical study found use of Applied Medical's Alexis wound protector/retractor was associated with a 52% reduction in pancreaticoduodenectomy surgical site infection, compared with surgeries that did not involve a wound protector. The trial included patients who had a biliary stent and were undergoing an elective pancreaticoduodenectomy in Calgary, Alberta, and Ottawa, Ontario.
Corindus Vascular Robotics has promoted Douglas Teany from senior vice president of research and development and operations to chief operating officer.
Draft guidance has been issued by the FDA that would revise guidance issued in 1998 on metal expandable biliary stents used for relief of bile duct narrowing caused by a tumor, providing new recommendations for premarket notification submissions. New information in the draft covers nonclinical bench testing, magnetic resonance compatibility for passive implants, and shelf life and packaging.
The FDA has granted Vallum 510(k) clearance for its nanotextured spinal interbody fusion device, called PEEKplus. The surface of the device has nanoscale concavities of 20 to 50 nanometers, which the company says have been shown to promote bone growth and fusion.