Over the past 2 years, concerted efforts have been undertaken by policymakers and FDA’s Oncology Center of Excellence to mitigate risks and improve the transparency of the accelerated approval program. These actions are crucial to restoring public trust – trust that has suffered considerable erosion.
Consumer-led healthcare will change patient care pathways, driving the industry to grow and collaborate in new ways, both with patients around their own health and with partners and innovators.
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.
Moximed snagged $40 million as it works to secure approval for its device, an implantable shock absorber for the knee designed to put off the need for full joint replacement. CEO Anton Clifford touts that the MISHA Knee System is the first of its kind.
The FDA approved Johnson and Johnson Vision Care's Acuvue Theravision with the antihistamine Ketotifen to treat allergy-induced itchy eyes for contact lens wearers.
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the regulatory nod to a PharmaEssentia drug that reduces the levels of those blood cells.
Following years of research and investment, liquid biopsies are steadily accumulating FDA approvals. The tests are being used in molecular profiling of solid tumors and as companion diagnostics for targeted cancer therapies.
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.
An infographic shows the different types of Covid-19 types that are either approved by the FDA or have CE Mark and how they work.
Headspace raised a total of $93 million in funding, including a $53 million equity round and $40 million of debt capital. The company said it would put some of the funds toward clinical tests, but has not shared new details on its efforts to seek FDA approval.
Augmedics, a Chicago startup that uses augmented reality for surgical guidance, secured 510K clearance from the FDA.
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
FDA approves the first-of-its-kind large-panel genetic diagnostic test from Foundation Medicine with CMS offering a preliminary National Coverage Decision on it. Commercial insurers so far have preferred to cover diagnostics tests that target a single or a handful genes.
After much speculation, FDA has given the green light to Puma's investigational breast cancer therapy neratinib (Nerlynx). Pivotal data had shown marginal benefits and a high rate of side effects, blurring the line between risk and reward.
Championed as the first new chemical entity approved for Parkinson's disease in over a decade, safinamide is really part of an existing family of drugs that have been on the market for decades.
FDA approves Absorb, first fully bioresorbable polymer stent, which will heat up competition with Boston Scientific's partially absorbable version.
Medical device companies have a lot to manage when it comes to maintaining requirements from the FDA, and doing everything manually just doesn't make sense anymore.