Teal Health received FDA approval for the first-ever at-home cervical cancer test, which seeks to give patients an alternative to the in-office pap smear. The test is already covered by four major payers in California.
The ability to take a drug to market is an important milestone, but it is not the entire picture. To truly move the needle, both clinically and commercially, biopharma companies must fine-tune their teams, approaches and incentives to produce unique and innovative products.
Finding the best analytics tools for health care revenue management can revolutionize operational processes. Compare the leading software options to discover helpful team resources.
Solving three major challenges in the development of new oncology drugs
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.
CeloNova Biosciences has received FDA approval for a new nanocoated polymer stent that has shown low thrombosis rates, a life-threatening complication of stenting.
The layout of your phlebotomy station can significantly impact efficiency. A well-thought-out setup ensures that every tool is within reach, minimizing unnecessary movement and reducing patient wait times.
"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(Opens in a new window) (ABT) announced it received FDA approval for MitraClip(Opens in a new window), 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. […]
St. Jude Medical(Opens in a new window) (STJ) announced FDA approval of its ILUMIEN OPTIS PCI Optimization System(Opens in a new window), 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 […]
Discover what tools are essential for efficient, safe surgical extractions in today’s health care landscape, from elevators to forceps and beyond.
After a difficult premarket approval process and tenuous relationship with the FDA, Atlanta’s CardioMEMS(Opens in a new window) 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 […]
Biotronik(Opens in a new window), 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(Opens in a new window), 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, […]
In her speech at Advamed 2013(Opens in a new window), FDA(Opens in a new window) Commissioner Dr. Margaret Hamburg(Opens in a new window) said a new challenge will be regulating in some way lab development tests. Now, LDTs are left to CLIA(Opens in a new window), which, Hamburg said, does not ensure they are properly designed, […]
Boston Scientific(Opens in a new window) (BSX) announced it has received U.S. Food and Drug Administration approval(Opens in a new window) 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(Opens in a […]
EP mapping (and the catheters that go with them) continues to be a hot topic in cardiac(Opens in a new window).St. Jude Medical(Opens in a new window) adds an approved ablation catheter enabled to work with its prize hen, MediGuide Technology, the EP 3-D navigation platform(Opens in a new window) that “allows physician to see […]