Mylan (NSDQ:MYL) and Biocon touted today that Semglee, their co-developed insulin glargine biosimilar, won approval in the European Union and in Australia. The product will be sold in a pre-filled disposable pen and is the first biosimilar from Biocon and Mylan to be cleared in Europe. Semglee will launch in Australia later this year, Mylan reported, […]
Reva touts first implant of Fantom Encore bioresorbable scaffold in Switzerland
Reva Medical (ASX:RVA) announced today that the company’s Fantom Encore bioresorbable vascular scaffold was used for the first time in Switzerland. The sirolimus-eluting device, which is made from Reva’s proprietary Tyrocore polymer, features a 95-micron strut profile and x-ray visibility. “Reva’s Tyrocore polymer makes Fantom Encore the most advanced bioresorbable scaffold with x-ray visibility and the […]
Dexcom wins FDA nod for first interoperable continuous glucose monitor
Dexcom (NSDQ:DXCM) shares jumped yesterday after the company scored a unique FDA approval for its G6 continuous glucose monitor, marking the first time the U.S. regulatory agency has cleared a CGM as “fully interoperable” with other medical devices. The company’s latest CGM also eliminates the need for patients to calibrate the device by pricking their fingers. […]
Convexity Scientific launches pocket-sized nebulizer
Convexity Scientific announced today that the company launched its Flyp nebulizer for patients with asthma and chronic obstructive pulmonary disease. The handheld, pocket-sized device was approved by the FDA in May last year. Convexity’s nebulizer includes a vibrating internal disk that produces an inhaled aerosol mist to deliver medication deep into patients’ lungs. The device […]
Milestone Scientific wins Health Canada license for epidural drug-delivery system
Health Canada issued a medical device license to Milestone Scientific (NYSE:MLSS) this week for the company’s CompuFlo Epidural computer-controlled anesthesia system. The Livingston, N.J.-based company developed CompuFlo Epidural to use dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and reduce complications in real-time. The system also has 510(k) clearance in the U.S. “Receiving […]
Sanofi’s high-capacity insulin pen wins FDA nod
Sanofi (NYSE:SNY) reported today that its Toujeo Max SoloStar high-capacity insulin pen won FDA approval and will be available in the third quarter of this year. The new device holds 900 units of long-acting insulin and delivers 160 units/mL of Toujeo insulin glargine in each injection, the insulin-maker touted. “This new high capacity pen has a […]
This new technology could help surgeons clear out leftover cancer cells
In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. [Image by MDO art director Matthew Claney] After his wife died of breast cancer in 2003, David Lee stepped away from […]
Kala Pharmaceuticals posts Q4 earnings miss
Shares in Kala Pharmaceuticals (NSDQ:KALA) tumbled -14% yesterday after the biopharma company missed expectations on Wall Street with its fourth-quarter and full-year results. The Waltham, Mass.-based company posted a net loss of -$11.3 million, or -46¢ per share, for the 3 months ended Dec. 31, for bottom-line loss of -34.5% compared with the same period last year. […]
Tela Bio lands $1m investment for surgical implants
Privately-held Tela Bio said this week that it landed a $1 million investment from ProMedica, a not-for-profit healthcare group serving northwest Ohio and southern Michigan. According to the deal, Tela Bio and ProMedica Innovations Venture Fund plan to strike a strategic relationship to educate surgical specialists at the ProMedica Hernia Center using Tela Bio’s regenerative […]
FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
The FDA approved Novo Nordisk‘s (NYSE:NVO) request to include heart health data on the label of its Tresiba insulin degludec product. The Danish insulin-maker evaluated its Type II diabetes drug in a 7,637-patient trial, assessing the therapy for cardiovascular safety compared to insulin glargine. Novo Nordisk’s Devote trial met its primary endpoint after Tresiba demonstrated […]
