On its surface, E. Hedinger AG v. Brainwave Science looks like a standard lawsuit alleging breach of contract. But the plaintiff’s claims go much further. Electromechanical company Hedinger (Wattwil, Switzerland) sued “brain-fingerprinting” company Brainwave Science (Southborough, Mass.) in 2017 in Massachusetts Superior Court over a distribution agreement that Hedinger claims Brainwave breached about a year […]
FDA gives massive Medtronic recall Class I designation
FDA has slapped the most serious designation on a recall of approximately 156,957 Medtronic (NYSE:MDT) dual-chamber pacemakers. The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and […]
Affluent Medical touts results of endovascular aneurysm repair study
Medtech startup Affluent Medical (Paris, France) said a study of its endovascular aneurysm repair (EVAR) system device showed patients had fewer endoleaks and needed fewer secondary interventions, and that their aneurysms shrank in volume and diameter. The company’s Kardiozis endovascular prosthesis uses thrombogenic fibers to embolize an abdominal aortic aneurism sac during a conventional EVAR procedure […]
NeoTract’s UroLift system gains expanded insurance coverage
Teleflex (NYSE:TFX) subsidiary NeoTract said that two more health insurers have agreed to offer coverage for the company’s UroLift system or patients with an enlarged prostate. The Wayne, Penn.-based subsidiary of Teleflex said that major U.S. insurer Humana and the Motion Picture Industry Pension & Health Plans (MPI), administered by Anthem Blue Cross, have added UroLift to its […]
IEEE publishes safety standards draft for medtech interoperability
The Institute of Electrical and Electronics Engineers (IEEE) Standards Association said it has published a draft set of standards intended to provide safe and secure medical device interoperability. IEEE 11073-20701-2018, also known as IEEE Approved Draft Standard for Service-Oriented Medical Device Exchange Architecture & Protocol Binding, completes the International Organization for Standardization (ISO)/IEEE 11073 family of standards for […]
A record year for device innovation
Emily Zetzer, clinical research associate, IMARC Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives. The FDA’s efforts to continue the […]
161m medical device units recalled in Q4 2018
The number of medical device units recalled in the fourth quarter of 2018 skyrocketed by 449% to 161 million from the same quarter a year ago, according to a report by Stericycle Expert Solutions. Those figures made it the second highest quarter for medtech units recalled since at least 2004. Medical device recalls fell by 1%, lower […]
Check-Cap’s cancer screening capsule will have U.S. study
Check-Cap (NSDQ:CHEK) said its X-ray-enabled, colorectal cancer-screening capsule will have a pilot study in the United States. The Isfiya, Israel-based startup makes the C-Scan System, an ingestible capsule used to detect precancerous polyps without the need for laxatives or an invasive procedure. The C-Scan system uses an ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, and proprietary […]
Brain tumor ‘monorail’ lands FDA breakthrough device nod
A “tumor monorail” that lures aggressive brain tumor cells to their death in an external container has won “breakthrough device” designation from FDA. The purpose of the device is not to destroy the glioblastoma tumor, but to halt its lethal spread, making the disease more of a condition to manage than a death sentence, according […]
Long-term stroke risk cut by carotid surgery or stenting
An international research team who compared the long-term effects of carotid artery surgery and stenting found the risk of stroke “remarkably low” even 10 years later, regardless of the type of procedure. Short-term stroke prevention was found to be better among surgery patients, but stenting technology has improved since these patients were implanted, said the study’s […]
New binoculars help cataract patients choose replacement lenses
Researchers in Spain have developed a device that simulates the improved vision that a cataract patient can have before corrective surgery even takes place. The scientists at the Spanish National Research Council’s Institute of Optics in Madrid compared the visual acuity obtained at different distances through a commercial trifocal lens (with focal points for close, intermediate […]
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