Nemaura Medical (OTC:NMRD) said today that shares of its common stock were approved to list on the NASDAQ exchange. The medtech company’s shares are slated to start trading on Jan. 25 under its existing symbol. Nemaura, which is developing a wireless continuous glucose monitor, finished its clinical trial program in Europe late last year and is […]
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Glytec touts patient outcomes for diabetes management system
Four new studies were published in this month’s issue of the Journal of Diabetes Science and Technology touting patient outcomes linked to Glytec‘s eGlycemic diabetes management system, the company reported. In both inpatient and outpatient settings, the use of eGMS for insulin therapy management was safer and more effective than traditional standards of care. The studies reported […]
Lenis inks distribution deal for needle-free injection system
Lenis Medical and Premier Distributing have inked an exclusive distribution deal for the U.S. sales of its needle-free injection system. Lenis’ high-velocity, spring-loaded device injects medication painlessly into the skin, according to the company. Lenis touted its system as being universally applicable to subcutaneous and intramuscular medications, including steroids, insulin, vaccines and orthopedic drugs. The […]
TapImmune brings therapeutic vaccines into the clinic for ovarian, breast cancer
In the past decade, new innovations and well-funded research have heralded in the era of immunotherapy. The pace of change within the field has amazed Peter Hoang, the chief executive of a Jacksonville, Fl.-based company working to develop therapeutic vaccines for cancer. “15 years ago, if you or I walked into a venture capitalist’s office, […]
Pulmatrix wins EU nod for inhaled dry-powder anti-fungal trial
The UK Medicines and Healthcare Products Regulatory Agency has given Pulmatrix (NSDQ:PULM) the go-ahead to launch its first-in-human study for an inhaled formulation of the anti-fungal drug, itraconazole. The company is evaluating its drug, Pulmazole, as a treatment for allergic bronchopulmonary aspergillosis in patients with asthma. The 42-patient Phase I/Ib study is slated to assess the drug’s safety […]
SFC Fluidics inks deal with JDRF to develop automated insulin delivery system
SFC Fluidics has inked a two-year deal with JDRF to develop an automated insulin delivery system that combines a continuous glucose monitor and an insulin delivery algorithm into a single disposable device. JDRF is slated to provide funding to the medical device company as part of its Artificial Pancreas Project, which aims to accelerate the […]
Braeburn dealt setback over monthly, weekly opioid abuse therapy
The FDA has issued a complete response letter to Braeburn Pharmaceuticals, denying its application for an investigational weekly and monthly buprenorphine depot injection designed to treat adults with opioid use disorder. The company reported that the dreaded CRL does not request additional clinical studies, but Braeburn did not elaborate as to what sort of additional […]
Medtech stories we missed this week: Jan. 19, 2018
From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news […]
EpiPen shortage in Canada to last until March
Pfizer Canada (NYSE:PFE) has warned Health Canada that there is a shortage of 0.3 mg EpiPen auto-injectors due to a manufacturing disruption. The company, which licenses the emergency allergy treatment from Mylan (NSDQ:MYL), reported that the problem should be resolved by March 2. There are no alternative auto-injectors available on the market in Canada for patients at […]
DarioHealth launches iPhone-compatible glucose meter in Australia
DarioHealth (NSDQ:DRIO) said today that the Lightning-enabled version of its blood glucose monitoring system is available in Australia. The device is designed to connect with the latest Apple products, including the iPhone 7, iPhone 8 and iPhone X. The product’s launch comes just one month after it won approval from Australian authorities. Israel-based DarioHealth reported that […]