The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is trying to succeed on a front where others have failed.
Coming soon to a screen near you: more psoriasis ads. FDA has approved J&J's guselkumab (Tremfya) for use in moderate to severe plaque psoriasis. Despite plenty of competition, annual sales are expected to be north of $1 billion by 2022.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
CeloNova Biosciences has received FDA approval for a new nanocoated polymer stent that has shown low thrombosis rates, a life-threatening complication of stenting.
"Most high-risk medical devices are being approved on the basis of a single pivotal trial, and these trials have clear weaknesses," said Yale University public health researcher Joseph Ross.
Everyone agrees patients are waiting far too long to access new drugs and treatments that enhance and extend lives. Most people concerned with accelerating treatments and cures are understandably focused on the process of drug discovery, development and approval. However, a less known but equally frustrating impediment is a federally required “scheduling” under the Controlled […]
Abbott Labs (ABT) announced it received FDA approval for MitraClip, a less-invasive mitral valve repair technology. The device allows physicians to repair the mitral valve using a catheter rather than open heart surgery for patients with mitral regurgitation. The company will launch the product in the U.S. immediately. While open heart mitral valve surgery is […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
St. Jude Medical (STJ) announced FDA approval of its ILUMIEN OPTIS PCI Optimization System, and the product’s U.S. launch. The device gives physicians a real-time, 360-degree panoramic view of the arteries, to help with stent placement and to guide treatment for patients with coronary artery disease. But what’s the true value proposition between this new […]
After a difficult premarket approval process and tenuous relationship with the FDA, Atlanta’s CardioMEMS received a mixed message from an FDA advisory panel on its CHAMPION HF Pressure Measurement System, an implantable sensor monitor to help guide treatment in patients with congestive heart failure. The panel voted unanimously that the device was safe, the majority […]
Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for its Ilesto DX, an implantable cardiac defibrillator. Earlier this year, it received FDA device approval for family of implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillators. This week’s approval is an “upgraded” device. This “smaller, thinner” new generation platform allows for a […]
In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA, which, Hamburg said, does not ensure they are properly designed, consistently assembled or clinically valid. She called for a “critical baseline” of these sorts of in […]
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Boston Scientific (BSX) announced it has received U.S. Food and Drug Administration approval for its IntellaTip MiFi XP catheter and 501(k) clearance for its Zurpaz 8.5F steerable sheath, growing its EP mapping/ablation technology portfolio. This makes it the third major player–following both St. Jude Medical, which acquired Endosense, and GE, which invested in Acutus Medical–to […]
EP mapping (and the catheters that go with them) continues to be a hot topic in cardiac. St. Jude Medical adds an approved ablation catheter enabled to work with its prize hen, MediGuide Technology, the EP 3-D navigation platform that “allows physician to see the exact location and orientation of devices” inside a patient’s heart […]
Wonders never cease. The Food and Drug Administration announced Friday that it was expanding the approved use of Botox, the wrinkle-fighting injection, to also treat adults with an overactive bladder. What!!?? Apparently, when Botox is injected into the bladder muscle, it causes the muscle to relax. And that increases the storage capacity of the bladder […]
Medical device maker Dune Medical Devices announced Wednesday that the company has received a pre-market approval from the Food and Drug Administration for its breast cancer detection device. The MarginProbe System can be used following the removal of cancerous tissue to know whether there is cancer in the immediate vicinity of the excised tissue. It […]
The Food and Drug Administration announced Tuesday that it has approved Framingham, Massachussetts-based HeartWare’s left ventricle assist device for heart failure patients awaiting a heart transplant. The HeartWare Ventricular Assist System is a mechanical, implantable pump that helps the heart’s left ventricle pump blood that is rich in oxygen to the body in patients whose […]