As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices. In a study published in the September issue of JACC: Cardiovascular Intervention, Reva Medical‘s (ASX:RVA) Fantom coronary […]
Drug-Device Combinations
UK warns about alarm failure for Roche’s insulin pumps
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, […]
Report: Boston Scientific could still seek to pull Synergy stent from India
Boston Scientific (NYSE:BSX) is reportedly still considering a market withdrawal in India for its Synergy adsorbable polymer stent, after repeated attempts to lift a government-imposed price cap were rebuffed by regulators there. Representatives from the Marlborough, Mass.-based medical device giant met yesterday with National Pharmaceutical Pricing Authority officials to discuss pulling Synergy from India, according to LiveMint. […]
Following regulatory win, GSK & Innoviva tout data for once-daily triple-med inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval. Now, the companies are touting results from a late-stage trial of Trelegy Ellipta, which is composed of an inhaled corticosteroid, a long-acting […]
BD launches ultra-fine 6mm needle for injection pen devices
Becton Dickinson (NYSE: BDX) introduced today its ultra-fine micro pen needle for use with injection pen devices. The 6 mm x 32G pen needle is compatible with leading pen injection devices, the company said. “We added the BD Ultra-Fine micro pen needles to ensure BD has a comprehensive portfolio that provide options to patients and reinforces BD’s commitment […]
Glytec personalized diabetes software helps patients maintain A1C reductions
A study presented at this year’s meeting of the European Association for the Study of Diabetes showed that diabetic patients who use insulin therapy guided by Glytec‘s Glucommander software achieved glucose control quickly and successfully maintained A1C reductions long-term, the company reported today. Once a patient gets their blood sugar into range, the Glucommander software […]
MiMedx files IND for Ph2 AmnioFix osteoarthritis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]
OptiNose wins FDA nod for Xhance nasal spray
OptiNose said today that the FDA approved its Xhance nasal spray for the treatment of nasal polyps in patients 18 years and older. The fluticasone propionate nasal spray is designed to deliver medication using OptiNose’s exhalation delivery system. The patient actuates the pump spray into one nostril while simultaneously blowing into the mouthpiece of the […]
ALR Technologies’ insulin dose adjustment feature wins FDA approval
ALR Technologies said today that the FDA approved the insulin dose adjustment feature of its ALRT diabetes management system. The ALRT system uses insulin dosing guidelines from the American Association of Clinical Endocrinologists and American Diabetes Association as reference doses. The reference doses are compared with a patient’s current insulin dose to decide if a patient’s […]
Micell raises $62m for MiStent SES
Micell Technologies said last week that it raised a debt-and-equity round worth nearly $62 million from a syndicate of 51 unnamed investors. Paris-based Micell makes the MiStent SES sirolimus-eluting absorbable polymer coronary stent, designed to treat coronary artery disease. The company, which reported a nearly $26 million round last November, said in a regulatory filing that the […]
