Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Axonics wins CE Mark for SNM, touts cost-efficacy study
Axonics Modulation Technologies said today it won CE Mark approval in the European Union for its SNM sacral nerve modulation system and announced the publication of a cost-efficacy study of the device in Neurourology and Urodynamics.
The SNM rechargeable neuromod system is designed to treat overactive bladder, urinary retention and fecal incontinence through sacral nerve stimulation, the Irvine, Calif.-based company said. Read more
4. Medella Health raises $1.4 million for CGM contact lens
Start-up Medella Health said last week it raised $1.4 million to fund its in-development smart contact lens designed to continuously monitor glucose levels and transmit glucose data to a mobile device.
The Canadian start-up, launched out of the Velocity Garage incubator, pulled in funds from the 1517 Fund, Fifty Years Fund, Garage Capital, BDC Capital and other investors. Read more
3. Zimmer Biomet reveals FDA warning letter
Zimmer Biomet today revealed a warning letter it received in late may over non-conformities with good manufacturing practice requirements for its quality system regulation at its Montreal, Quebec facilities.
The letter, which came based on a January inspection of the company’s facilities, restricts the clearance of premarket approval applications for Class III devices which are affected by the quality system regulation deviations. The company said that it has no such applications. Read more
2. ESC adds St. Jude’s CardioMems to guidelines for directed HF therapy
The European Society of Cardiology has added St. Jude Medical‘s CardioMems heart failure system to its guidelines as a “directed therapy management and monitoring tool for heart failure patients,” the company said today.
The CardioMems device consists of a wireless sensor implanted in the pulmonary artery via catheter to directly measure pressure in the vessel. The device is designed to help physicians manage patients’ medication to control their heart failure before visible changes to weight or blood pressure occur. Read more
1. Ocular Therapeutix shares plummet as 2nd Phase III misses primary endpoint
Ocular Therapeutix saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint.
Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears. Read more
