FDA Approval
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MedCity Influencers, BioPharma
What is the Next Chapter for FDA’s Accelerated Approval’s in Oncology?
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.
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MedCity Influencers, Health Tech
The future of wearable health tech
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.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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New funding fuels device-maker’s pursuit of FDA approval
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.
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J&J receives FDA approval for drug-eluting contact lens
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.
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FDA approves PharmaEssentia interferon drug for a rare type of blood cancer
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.
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String of FDA approvals gives momentum to liquid biopsies
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.
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Here are some of the approved Covid-19 tests available and how they work
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.
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Meditation app Headspace raises $93M
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.
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Startups, Devices & Diagnostics, Health Tech
FDA approves startup’s AR headset for surgical guidance
Augmedics, a Chicago startup that uses augmented reality for surgical guidance, secured 510K clearance from the FDA.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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FDA considering imposing 10-year limit when manufacturers choose older predicates
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.
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FDA approves Foundation Medicine’s genetic diagnostic test as CMS paves the way for coverage
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.
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Puma’s controversial cancer drug secures FDA approval
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.
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Newly-approved Parkinson’s drug isn’t that novel
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.
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Bioresorbable heart stent wars to heat up in U.S.
FDA approves Absorb, first fully bioresorbable polymer stent, which will heat up competition with Boston Scientific’s partially absorbable version.
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Health IT, Devices & Diagnostics
Medical device companies can protect themselves with complaint management software
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.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
