Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses. The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with […]
“Snake oil” BP app got high user marks despite inaccurate results
People may like mobile blood pressure apps better when the apps reveal positive results, even if those results are inaccurate 80% of the time, according to a recent study. A team of researchers who previously revealed the inaccuracy of the Instant Blood Pressure (IBP) app returned to the topic to study 81 adults who compared the app’s readings […]
Study slams FDA’s ‘fast-track’ approval process
More than 98% of the 161 foot and ankle implants that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process allows […]
SpaceLabs’ Arkon anesthesia system recalled again
The FDA has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use […]
Saudi Arabia updates clearance policy for medical device shipments
By Stewart Eisenhart, Emergo Group The Saudi Food and Drug Authority (SFDA) has published an update to its requirements for clearance of medical device shipments at Saudi ports of entry. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
Envoy Medical’s hearing implant wearers can get MRIs
The FDA has given Envoy Medical’s landmark Esteem middle-ear implant clearance for MR-conditional labeling in both 1.5 and 3.0 Tesla (T) scanning environments. White Bear Lake, Minn.-based Envoy introduced the Esteem — the first fully implantable device to treat hearing loss in the U.S. — in 2010. Surgeons and audiologists who work closely with hearing […]
ARTMS’ system may ease cost, shortage of valuable radioisotopes
ARTMS Products (Vancouver, B.C) has won the CE mark for its first-in-class, advanced technology Quantm irradiation system, designed to produce high-value medical imaging isotopes such as technetium-99m (Tc-99m) on medical cyclotrons. Tc-99m is given to nearly 50,000 Americans every day to diagnose cancer and heart disease. It is used in more than 80% of all nuclear […]
CryoLife shares up on street-beating Q2 revenues
CryoLife (NYSE: CRY) beat analysts’ revenue estimate by 11% in the quarter ended June 30, driving shares up $3.75 in mid-afternoon trading. Atlanta, Ga.-based CryoLife’s revenue hit $68.5 million in the quarter, up from $47.8 million for the same period of 2017. Its bottom line slumped to $226,000 or 0.1¢ per share, well below Wall Street’s projection of 0.8¢ […]
Northwell’s prosthetic leg could get amputees back in the swim
A New York State heathcare provider has developed a 3D-printed artificial leg to help combat veterans and other amputees to swim again. Northwell Health’s prosthetic, “The Fin,” is the first such prosthetic leg attachment to give amputee swimmers the ability to navigate from land to the water and back without having to switch prosthetics. Northwell has begun […]
Surmodics’ acquisition hits earnings bottom line
Surmodics (NSDQ:SRDX) today posted earnings that beat expectations on Wall Street and adjusted its guidance for the remaining year. The Eden Prairie, Minn. company took an expected hit to earnings due to its $5 million-plus acquisition of Embolitech’s thrombectomy platform. Surmodics posted a net loss of -$2.68 million compared with a profit of $720 million in the […]
Spectralytics invites customers to ‘camp out’ at new development center
Spectralytics has completed a dedicated product development center in Maple Plain, Minn. to speed delivery of prototypes to customers and free up the production lines in its other facilities. Spectralytics’ two existing plants in Dassel, Minn., 55 miles west of the Twin Cities, offer laser cutting, welding, drilling, ablation, marking, electropolishing, assembly, and engineering services […]
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