Vascular Graft Solutions has reported the first clinical use of its Frame external support technology in high-flow arteriovenous (AV) fistulas. The first five cases were performed by Dr. Vladimir Matoussevitch from Cologne University Hospital in Germany. The braided cobalt chrome, kink-resistant external support was designed for autologous vein grafts in bypass or reconstruction of peripheral arterial
Vascular Graft Solutions’ aneurysm graft used in hemodialysis patients
August 20, 2018 By Leave a Comment
Murata to boost MEMS production in Finland
August 20, 2018 By Leave a Comment
Murata Manufacturing announced it is investing $45 million in the purchase of two factory buildings and the construction of a third to manufacture micro electro mechanical systems (MEMS) sensors in Finland. The Kyoto-based company had been leasing the two buildings it purchased and expects to complete the adjacent 172,000-square-foot factory in Vantaa, Finland, by the end
ValenTx raises $10.3 million for implantable gastric bypass device
August 17, 2018 By Leave a Comment
Startup ValenTx has attracted nearly $10.3 million from 32 investors, according to a filing with the Securities & Exchange Commission. The Maple Grove, Minn. company is developing a removable gastric bypass device as an alternative to Roux-en-Y gastric bypass surgery. It raised $10,271,050 in the round begun July 18, 2018. The ValenTx endoluminal bypass therapy
FDA clears CoreLink’s new spinal implant
August 17, 2018 By Leave a Comment
Spinal implant maker CoreLink has landed FDA 510(k) clearance for a new anterior lumbar (ALIF) interbody device. The Foundation 3D ALIF uses the company’s proprietary mimetic metal technology, which mimics natural bone characteristics, including 100% open-pore architecture and micro-roughened porosity with hydro-wicking properties. The new ALIF design also has patent-pending technology that creates a combination of
Bone Index wins CMS coverage for osteoporosis diagnostic device
August 16, 2018 By Leave a Comment
Finnish orthopedic device manufacturer Bone Index said it has won Medicare and Medicaid coverage for its Bindex point-of-care osteoporosis measurement device for ambulatory surgical and outpatient settings. Bindex measures the cortical bone thickness of the tibia and an algorithm calculates the density index, a parameter that estimates bone mineral density at the hip as measured
SPR Therapeutics’ new PNS system wins FDA nod
August 16, 2018 By Leave a Comment
The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems. The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only
Hologic will distribute analgesic system to aesthetic providers
August 15, 2018 By Leave a Comment
Hologic (NSDQ:HOLX) has inked an agreement between its Cynosure division and Porter Instrument to distribute Porter’s nitrous oxide and oxygen system, Nitronox, in the United States and Canada. Nitronox is a self-administered nitrous oxide and oxygen delivery system that provides a fast-acting inhaled analgesic to help patients manage discomfort and anxiety while remaining alert and
What you need to know about medical device packaging
August 15, 2018 By Leave a Comment
A recent study about recalls of foot and ankle implants included a portion that likely drew less attention than the headline. Some of these implants were recalled because they arrived at the hospital in an unsterile condition, and the authors said faulty packaging may have been the cause. Poor packaging can cause a host of
Smithwise helps startup find its focus
August 14, 2018 By Leave a Comment
After Basil Leaf Technologies won the Qualcomm Tricorder XPrize in 2017, founder Dr. Basil Harris needed help figuring out how to bring this almost-all-in-one diagnostic tool to market. Basil Leaf’s mobile platform DxtER includes a group of non-invasive sensors that can wirelessly communicate with a smart device as they collect data on vital signs, body
Avinger posts loss on disappointing sales
August 14, 2018 By Leave a Comment
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
August 14, 2018 By Leave a Comment
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
Study slams FDA’s ‘fast-track’ approval process
August 13, 2018 By 2 Comments
More than 98% of the 161 foot and ankle devices 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
SpaceLabs’ Arkon anesthesia system recalled again
August 13, 2018 By Leave a Comment
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
Envoy Medical’s hearing implant wearers can get MRIs
August 8, 2018 By Leave a Comment
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
ARTMS’ system may ease cost, shortage of valuable radioisotopes
August 8, 2018 By Leave a Comment
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
