FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
Inspire Medical wins coverage from five more BCBS plans
Inspire Medical Systems (NYSE:INSP) (“Inspire”) said it has secured positive coverage policies for its Inspire neurostimulation therapy, intended to treat obstructive sleep apnea, from an additional five Blue Cross Blue Shield Association healthcare plans. These plans include Blue Cross Blue Shield of Mississippi, BCBS Regence, Premera Blue Cross, BCBS of Kansas, and BCBS of Massachusetts. […]
Global Kinetics touts movement-monitoring study results
Global Kinetics’ Personal KinetiGraph (PKG), a wearable device for Parkinson’s disease patients, provided more information about symptoms than a routine clinic visit, a recent study found. The device, which monitors, quantifies and reports Parkinson’s movement symptoms, generated new data that was significant enough to change the medical management of one-third of study participants, according to […]
Vectorious starts trial of implantable wireless heart monitor
Vectorious Medical Technologies said it has begun a first-in-human trial of its left atrial pressure monitoring device. Tel Aviv-based Vectorious is developing the V-Lap implantable wireless heart monitor, which is designed to monitor pressure in the heart’s left atrium. The Vector-HF trial will enroll up to 30 patients at six sites across Germany, Israel, Italy and the U.K. […]
Cellect Biotechnology launches U.S. clinical trial
Cellect Biotechnology (NSDQ:APOP) said it is collaborating with Washington University on a study of its ApoGraft stem cell selection technology for bone marrow transplantations. This will be the first clinical trial in the U.S. using Tel Aviv, Israel-based Cellect’s ApoGraft, which is designed to prevent acute graft-versus-host disease following bone marrow transplantation. The company previously reported positive safety and […]
Resonetics continues buying spree, snaps up Minnesota firm
Resonetics said it has acquired Caribou Technologies (Blaine, Minn.), a supplier of centerless grinding, forming, coiling, machining and laser processing for the medtech industry. In addition to servicing a large number of medical device manufacturers in the Twin Cities market, Caribou has built a strong and growing customer base in high growth market segments around the world, according […]
Could this device replace pacemaker batteries?
The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College. Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college. Get the full […]
Ortho RTi touts rotator cuff study results at conference
Startup Ortho Regenerative Technologies (CNSX:ORTH) said two new studies have validated its product’s ability to improve the repair of two distinct joint tissues – the rotator cuff tendon and articular cartilage. The rotator cuff study results were presented yesterday at the Annual Orthopaedic Research Society meeting in Austin, Texas. Get the full story on our sister site, Medical Design […]
Relievant back-pain device study stopped for positive results
Relievant Medsystems said it has halted enrollment in a clinical trial of its Intracept lower-back pain device due to the device’s superiority over non-surgical management. The Level I Intracept study found a “highly significant reduction” in the Oswestry Disability Index (ODI) score in patients treated with the Intracept procedure over patients in the non-surgical management arm. The […]
Boston Sci joins cyber-physical R&D collaborative
Boston Scientific (NYSE:BSX) has joined PracticePoint, a membership-based, cyber-physical medtech R&D and commercialization alliance founded by Worcester (Mass.) Polytechnic Institute (WPI). PracticePoint is an agile, scalable collaborative research facility featuring point-of-practice clinical suites — including a residential suite, rehabilitative care suite, controlled care suite, and surgical imaging suite — co-located with engineering and manufacturing capabilities and […]
Pain-management firm SPR Therapeutics seeks to raise $20m
SPR Therapeutics has raised $8 million of a $20 million Series C round of funding that began Jan. 19, according to an SEC filing. The Cleveland-based company’s Sprint peripheral nerve stimulation (PNS) system is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The product was launched in November 2018 with indications […]