MedCity News

MAY 5, 2023

Formus Labs, a New Zealand-based medical technology startup, has received 510(k) clearance from the FDA for Formus Hip, its fully automated 3D software for hip replacement preoperative planning. The company hopes to start piloting the product at healthcare sites across the U.S. in the next few months.

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World of DTC Marketing

JUNE 22, 2022

America’s profit-riddled healthcare-industrial complex consumes 17% of GDP, equivalent to $3.6trn a year. However, changes are slowly being implemented that could lower healthcare costs. Healthcare is ripe for disruption, but any attempt to disrupt our state of healthcare has been met with pushback and challenges.

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MedCity News

JULY 13, 2023

FDA approval of Opill makes it the first oral contraceptive that may be used without a prescription. Clinicians say over-the-counter availability will lower barriers to access to a key component of reproductive healthcare.

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MedCity News

JUNE 16, 2022

At AWS’ Thursday conference for healthcare and life sciences innovation, the company’s chief security officer explained how the company is evaluating the test in clinical trials and preparing to file for its FDA approval.

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MedCity News

FEBRUARY 12, 2023

Here is a selection of recent executive hires, departures and layoffs occurring across the healthcare industry.

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European Pharmaceutical Review

MARCH 26, 2025

The US Food and Drug Administration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over. The post FDA approves first-in-class oral antibiotic appeared first on European Pharmaceutical Review.

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MedCity News

APRIL 3, 2024

This week, Eko Health received FDA clearance for a new AI-powered tool that aids in the early detection of low ejection fraction, a key indicator of heart failure. The post Eko Health Gains FDA Clearance For Cardiology Algorithm That Can Detect Heart Failure in 15 Seconds appeared first on MedCity News.

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MedCity News

SEPTEMBER 5, 2024

The startup’s AI platform, which was cleared by the FDA last year, automates ultrasound reporting so that healthcare providers can conduct these exams with greater accuracy and efficiency. Samsung announced its plans to acquire French medtech startup Sonio.

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World of DTC Marketing

OCTOBER 21, 2021

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

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World of DTC Marketing

JUNE 23, 2021

One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Source: STAT News Our healthcare system can’t continue to support drugs that don’t have good clinical outcomes behind them. I, therefore, find the FDA’s decision to be puzzling.

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World of DTC Marketing

MARCH 18, 2021

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. The post Dear FDA: WTF?

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Fierce Pharma

APRIL 10, 2024

FDA chided Kilitch Healthcare India for “poor practices” tied to written procedures around microbial contamination, shoddy lab records, behaviors that could have caused contamination and quality control lapses. In a four-observation warning letter issued this week, the U.S.

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World of DTC Marketing

JULY 13, 2021

SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. Our healthcare system cannot continue to support marginally effective drugs.

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MedCity News

FEBRUARY 22, 2024

About 80% of all FDA-approved healthcare AI applications are related to radiology — but due to a massive workforce shortage, radiologists don’t have the time to explore, choose, validate and implement the tools available to them.

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Fierce Pharma

AUGUST 27, 2024

In June, when the Supreme Court voted 6-3 to overturn the Chevron doctrine, it brought significant impact for the healthcare industry and federal regulators like the FDA and the Centers for Medicare & Medicaid Services. An expert recently discussed the ramifications of the ruling during a Fierce Pharma podcast interview.

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Fierce Pharma

JULY 11, 2023

travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. | U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting.

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Pharma Marketing Network

NOVEMBER 24, 2024

Understanding the Pharma Market Landscape To succeed, you need to understand the shifting dynamics of healthcare marketing. Targeting Healthcare Professionals (HCPs) Why focus on HCPs? Digital Marketing: A Game-Changer for Pharma The digital revolution has transformed healthcare marketing.

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World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. The FDA gave approval to a medication despite a strong NO vote from their advisory panel of scientific advisers. Where to start? John Carroll, Endpoints.

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PharmaVoice

JANUARY 16, 2024

FDA Commissioner Dr. Robert Califf recently spoke about the future of AI and machine learning and the need for constant vigilance to improve healthcare systems.

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World of DTC Marketing

JUNE 24, 2021

If the FDA understood consumer behavior like marketers instead of scientists, they would understand how DTC works. More importantly, the FDA needs to work with online sites to eliminate health misinformation. I’ve been pretty vocal about the need to address healthcare changes, and a good start would be with the FDA.

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MedCity News

JANUARY 22, 2024

No matter the outcome, it’s certain that the cost of drugs will not be an issue easily resolved anytime soon even though several other states also have laws allowing for drug imports.

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Fierce Pharma

JUNE 13, 2023

Morgan Healthcare Conference by scooping up liver disease specialist Albireo, the centerpiece of the buyout, Bylvay, has won a coveted label expansion. After Ipsen made a splash at this year's J.P. After Ipsen made a splash at this year's J.P.

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Medical Device Success

MAY 30, 2021

How will the Four Forces shaping healthcare affect your sales and marketing strategies and tactics? Mark Dixon once led one of the largest healthcare systems in the US. Now he is a consultant for both healthcare systems and some of the largest life science companies in the world. Reading time: 3 – 4 minutes.

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Nixon Gwilt Law

DECEMBER 3, 2024

With down rounds and unpriced rounds occurring on the equity side, healthcare innovation founders may consider a venture debt credit facility for additional working capital and to shore up their balance sheets. A knowledgeable legal team is critical in healthcare venture debt deals due to the dual complexities of corporate and healthcare law.

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pharmaphorum

APRIL 24, 2024

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

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MedCity News

OCTOBER 26, 2022

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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MedCity News

FEBRUARY 20, 2024

FDA’s regulation of single-use device reprocessing effectively made the U.S. the leader in EP sustainability efforts early on. However, very little has been done to build on this early leadership.

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MedCity News

SEPTEMBER 24, 2024

Many great ideas fail because of a fundamental misunderstanding or underestimation of the unique barriers entrenched within healthcare. Here are some key considerations that innovators from non-healthcare backgrounds need to be prepared for.

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Infuse Medical

DECEMBER 17, 2024

3D medical animation has become a revolutionary tool in today’s fast-paced healthcare environment, where clarity and accuracy rule. Expertise in both animation and healthcare A specialist company combines knowledge of the healthcare sector with animation skills. What is 3D Medical Animation?

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MedCity News

MAY 27, 2024

If Medicare acts, the potential of AI-enabled technologies to improve healthcare outcomes for patients, regardless of their geographic location or socioeconomic status, will be closer to being fully realized. The post Making Access to AI-enabled Medical Devices Equitable for All appeared first on MedCity News.

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Infuse Medical

JULY 4, 2024

If so, it is important to understand the regulatory requirements of the FDA. Do you know the FDA is the Food and Drug Administration? It is essential to understand the FDA’s definition of a medical device. Let’s see FDA regulations for medical device training.

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pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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MedCity News

JUNE 12, 2023

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities.

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World of DTC Marketing

APRIL 25, 2022

Fitbit collected such information, Faranesh told KHN, as part of a survey submitted to the FDA for clearance of its device. The challenge is getting to the doctor promptly without needing that maze that has become our healthcare system. This is precisely the feedback this author received during research.

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MedCity News

MARCH 2, 2023

When asked what the biggest threats facing them were, 94% of employers said high-cost pharmacy claims, 91% said medical inflation and 91% said million dollar treatments being approved by the FDA, according to a new survey from the Midwest Business Group on Health.

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MedCity News

OCTOBER 27, 2022

Earlier this year, the FDA approved the biotech’s first rare disease drug, a treatment for a type of anemia. Agios Pharmaceuticals sold royalties to an approved cancer drug to get immediate cash to support its new focus on rare diseases.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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