Allergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators. France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee […]
Implants
In2Bones intros ‘see-through’ implant for flat feet
Orthopedic surgical device developer In2Bones announced the global launch of its “see-through” PitStop implant for children and adults with flat feet. One of the most common foot deformities, flat-foot often starts during adolescence and continues into adulthood. In2Bones (Memphis, Tenn.) developed the PitStop subtalar implant to restore the stability of a patient’s arch during the walking […]
Nexxt Spine launches Saxxony posterior cervical spine system
Nexxt Spine has received FDA 510(k) clearance and has commercially launched its Saxxony Posterior Cervical Thoracic System. The system is designed to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments through posterior screw fixation. “The Saxxony System adds a robust posterior complement to our well received anterior cervical fixation offering as […]
FDA chooses 8 medtech companies for opioid crisis challenge
The FDA has selected eight medtech companies to develop devices to help reduce the country’s opioid abuse crisis. More than 250 companies submitted entries to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, announced in May. Those selected include Masimo Corp. and deep-brain-stimulation company Brainsway Ltd. The companies will be expected to […]
Is the medical device industry endangering people?
The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny. The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about […]
FDA clears Spinal Elements’ surface coating technology
Spinal Elements said that the FDA has issued 510(K) clearance for the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. The Carlsbad, Calif. company said that a number of products in its portfolio use Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device. Interbody fusion products with Ti-Bond […]
Senseonics reports mixed Q3 results
Shares in Senseonics (NYSE:SENS) fell today after the medical device maker missed EPS expectations but met sales estimates on Wall Street with its third quarter financial results. The Germantown, Md.-based company posted a net loss of -$31.9 million on sales of $5.2 million for the 3 months ended Sept. 30. Quarterly net losses were up 83% on sales […]
Ocular Therapeutix shares fall after Q3 earnings miss
Shares in Ocular Therapeutix (NSDQ:OCUL) fell today after the company missed EPS estimates on Wall Street with its third-quarter financial results. The Bedford, Mass.-based company posted a net loss of -$15 million on sales of $498,000 for the 3 months ended Sept. 30. Sales for the quarter were down -5% compared with the same period last year. Get the […]
INVO Bioscience touts two women’s ability to carry the same baby
INVO Bioscience today announced that a child had been born to a same-sex couple in which both partners were able to carry the baby in separate phases of the pregnancy. The couple, Bliss and Ashleigh Coulter of Mountain Springs, Texas, welcomed their son, Stetson, in late October. The women and their doctors used INVO Bioscience’s […]
The top 10 medical disruptors of 2019
The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year. The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150. […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal […]