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
FDA finalizes streamlined bundled, quarterly MDR reporting system
August 16, 2018 By Leave a Comment
The FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting. The program was created in part through public comments received by the FDA and is intended to allow manufacturers to report “certain device malfunctions in summary form on a quarterly basis” instead of an
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
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
Sensus squeaks past Wall Street Q2 expectations
August 3, 2018 By Leave a Comment
Sensus Healthcare (NSDQ:SRTS), narrowly beat analysts’ earnings expectations for the second quarter but missed the consensus sales forecast, sending share prices down today. Boca Raton, Fla.-based Sensus posted net losses of -$540,651, or -4¢ per share, on sales of $6.1 million for the three months ended June 30, cutting its losses by -29.2% on sales growth
Integer adds radial introducer for patients with smaller arteries
August 1, 2018 By Leave a Comment
Integer’s new radial access introducer kit for interventional cardiology and peripheral vascular procedures has won FDA clearance and the CE Mark. RadialSeal was engineered for optimal device compatibility and ease of insertion, the company said in a statement. Its thin-walled sheath design minimizes outer diameter while maximizing inner diameter, according to Payman Khales, president of Integer’s cardiovascular division.
CarboFix wins FDA nod for its carbon/PEEK pedicle screws
July 30, 2018 By Leave a Comment
CarboFix Orthopedics Ltd. has won FDA approval for a spinal screw system for use in people with advanced spinal cancer. The CarboClear carbon fiber pedicle screw system was designed to restore the integrity of the spinal column, even in the absence of fusion, for a limited time period in patients with advanced-stage thoracic and lumbar
Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
July 27, 2018 By Leave a Comment
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial
Endomagnetics’ device could help ID cancerous lymph nodes
July 25, 2018 By Leave a Comment
The FDA has approved Endomagnetics Inc.’s magnetic device system for guiding lymph node biopsies in breast cancer patients undergoing a mastectomy. The Sentimag Magnetic Localization System detects magnetic seeds or a magnetic drug to identify the specific lymph nodes to which cancer cells are most likely to spread from the original tumor. A biopsy of
Who’s afraid of the big, bad PMAs?
July 12, 2018 By Leave a Comment
PMAs at FDA are often a scary process for medical devices developers. But that doesn’t have to be the case, according to Michael Drues, a regulatory consultant based outside Boston who has worked with both medical device companies and FDA. There are many myths around premarket approval, such as the idea that PMAs always require
Here’s how FDA officials think you can legally promote off-label device, drug uses
June 13, 2018 By 2 Comments
The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the
FDA launches medical device innovation challenge to combat opioid crisis
May 30, 2018 By Leave a Comment
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go
